protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT01283542 | 10.5 | Secondary objectives | 10.5 Secondary objectives
Analysis population All secondary efficacy analyses will be based on the full analysis set (FAS). The safety analysis set will be used for all safety analyses. | [
"Analysis population"
] |
NCT01283542 | 10.5.1 | Efficacy variables and analysis | 10.5.1 Efficacy variables and analysis The secondary efficacy endpoints are described on section 3.3.2. The changes in mean and percent tumor volume variation from baseline to Weeks 4, 12, and 24 will be presented together with the 90% confidence interval (90% CI). If the data are in a non-normal distribution, median C... | [] |
NCT01283542 | 10.5.3 | Safety analyses and parameters | 10.5.3 Safety analyses and parameters The safety evaluation will be based mainly on frequency of adverse events (AEs), number of patients with laboratory values outside the reference ranges, and number of patients with clinically significant changes in ECGs. Other safety data (for example, vital signs and special tests... | [] |
NCT01283542 | 10.5.3.1 | Adverse events | 10.5.3.1 Adverse events All AEs recorded during the study will be summarized. The incidence of treatment-emergent AEs (new or worsening from baseline) will be summarized by system organ class, severity (based on CTCAE grade), type of AE, and relationship to the study drug. Deaths that may be reported as SAEs and non-fa... | [] |
NCT01283542 | 10.5.3.2 | Laboratory abnormalities | 10.5.3.2 Laboratory abnormalities All laboratory values will be converted in SI units and the severity grade will be calculated using the appropriate Common Toxicity Criteria (CTC). The frequency of laboratory abnormalities will be shown by parameter and study day. Considerably abnormal laboratory values (new or worsen... | [] |
NCT01283542 | 10.5.3.3 | Other safety data | 10.5.3.3 Other safety data Weight, height, and vital signs will be summarized in each period, using descriptive statistics (N, mean, standard deviation, median, minimum, and maximum). Physical examination abnormalities, ECOG performance status, radiology tests, ECGs, MRIs, and visual evaluations will be identified and ... | [] |
NCT01283542 | 10.5.4 | Tolerability | 10.5.4 Tolerability Dose decreases and AEs related to the study drug, e.g., gastrointestinal disorders, glucose metabolic disorders, cardiac dysfunctions, laboratory abnormalities, infections, and injection site reactions, will be summarized by presenting counts and percentages for the safety population. | [] |
NCT01283542 | 10.6 | Sample Size Calculation | 10.6 Sample Size Calculation This study is a proof of concept. The sample size of 19 evaluable patients was selected without taking statistical power into account. The response rate (proportion of patients with tumor volume decrease ≥ 20%) of at least 10% is considered clinically significant for this patient population... | [] |
NCT01283542 | 11 | Administrative procedures | 11 Administrative procedures | [] |
NCT01283542 | 11.1 | Enrollment compliance | 11.1 Enrollment compliance When all inclusion / exclusion criteria are met and a patient is qualified to enter the study and when all information is entered into the eCRF, enrollment will be allowed. This will allow enrollment to be properly monitored and will ensure that the populations with each type of tumor are app... | [] |
NCT01283542 | 11.2 | Ethic and regulatory compliance | 11.2 Ethic and regulatory compliance This clinical study was designed and must be implemented and reported according to the protocol, the Harmonized Tripartite Guideline for ICH Good Clinical Practice, the applicable local regulations (including European Resolution 2001/20/EC and U.S. Code of Federal Rules Title 21), a... | [] |
NCT01283542 | 11.3 | Investigator's and REC's responsibilities | 11.3 Investigator's and REC's responsibilities The protocol and the proposed informed consent form must have been reviewed and approved by a duly established Research Ethics Committee (REC) before the start of the study. A signed and dated statement that the protocol and informed consent form were approved by the REC m... | [] |
NCT01283542 | 11.4 | Informed Consent Form | 11.4 Informed Consent Form Eligible patients may only be enrolled in the study after providing the written informed consent (witnessed, whenever required by law or regulation), approved by the REC or, if unable to do it, after this consent is provided by the patient's legally acceptable representative. In cases in whic... | [] |
NCT01283542 | 11.5 | Protocol amendments | 11.5 Protocol amendments Any change or addition to the protocol may be performed only by means of a written protocol amendment, which must be approved by Novartis, Health Authorities, whenever required, and by the REC. Only amendments required for the safety of patients may be implemented before approval by the REC. In... | [] |
NCT01283542 | 11.5.1 | History of amendments | 11.5.1 History of amendments Amendment 1 extends the treatment schedule for patients from week 24 to week 96. For the purpose of a reference for long-term safety and efficacy evaluation of pasireotide LAR treatment, patients benefiting from the treatment with this medication according to the evaluation by the physician... | [] |
NCT01283542 | 11.6 | Discontinuation of the study | 11.6 Discontinuation of the study Participation in this study is voluntary. Research subjects may withdraw their consent. The investigator may discontinue the participation of any research subject in this study, at any time, if considered as in his/her best interest. Novartis Biociências S. A. may discontinue the study... | [] |
NCT01283542 | 11.7 | Supply and new supply, storage of the drug, and traceability / accountability of the study drug | 11.7 Supply and new supply, storage of the drug, and traceability / accountability of the study drug Study drugs must be received by a designee at the study site, handled and stored safely and appropriately, and kept in a safe place, with access restricted only to the investigator and his/her designees. Upon receipt, p... | [] |
NCT01283542 | 12 | Protocol compliance | 12 Protocol compliance The investigators agree to dedicate due diligence to avoid protocol deviations. The investigator must not, under any circumstances, contact Novartis or its representatives, if any, monitoring the study to request approval for a protocol deviation, as no authorized deviation is allowed. If the inv... | [] |
NCT01283542 | 13 | Publication policy | 13 Publication policy Any formal presentation or publication of the study data will be considered as a joint publication by the investigator(s) and Novartis team. Authorship will be determined by mutual agreement, based on the number of patients enrolled. For multicenter studies, it is mandatory that the first publicat... | [] |
NCT01283542 | 14 | References (available upon request) | 14 References (available upon request) Adams, R. L., Adams, I. P., Lindow, S. W., Atkin, S. L. 2004, "Inhibition of endothelial proliferation by the somatostatin analogue SOM230", Clin Endocrinol (Oxf.), vol. 61, no. 4, pp. 431-436. Agresti A. 1998, "Approximate is Better than Exact for Interval Estimation of Binomal P... | [] |
NCT01445730 | 1 | Screening | 1. Screening Subjects will undergo physical examination (cardiorespiratory status, blood pressure, BMI, waist-hip-ratio and recording of their medical history. A blood sample is drawn after an overnight fast. - 1.1 The screening measures: serum triglycerides, LDL cholesterol and HDL cholesterol, blood count, creatinine... | [] |
NCT01445730 | 2 | Lipolytic enzymes and genetic studies | 2. Lipolytic enzymes and genetic studies - 2.1 Subjects will receive 75 IU/kg heparin i.v. to determine lipoprotein lipase and hepatic lipase masses and activities. 71 - 2.2 A blood sample for DNA extraction is drawn. Single nucleotide polymorphisms (SNPs) in genes involved in regulation of lipid metabolism, insulin re... | [] |
NCT01445730 | 3 | Oral fat load study | 3. Oral fat load study After a 12-h fast, subjects will receive a mixed meal consisting of bread, butter, cheese, low fat milk and tea or coffee (63 g carbohydrates, 56 g fat (P/S ratio 0.11), 39.9 g protein) in the morning. Blood samples are drawn before and up to 8 hours after the meal. During this time only water wi... | [] |
NCT01445730 | 4 | Determination of liver, subcutaneous and intra-abdominal fat | 4. Determination of liver, subcutaneous and intra-abdominal fat On a separate visit the amount of liver, subcutaneous and visceral fat are determined. Proton magnetic resonance spectroscopy is performed with a 1.5 T whole-body device80 to determine liver fat content. Magnetic resonance imaging is used to determine subc... | [] |
NCT01445730 | 5 | Oral glucose tolerance test | 5. Oral glucose tolerance test An oral glucose tolerance test (For all sampling: please see Excel: Fructose\sample handling\fatload\ogtt\heparin\TIMEPOINTS\040612) will be performed in the morning after an overnight fast at screening as well at the end of the 3 month diet period. Sampling time will be at 0, 5, 10, 30, ... | [
"SUMMARY:",
"Substudy (in Helsinki)",
"Kinetic protocol visit (replacing study visit 3)",
"Kinetic modeling",
"Novelty and importance",
"Collaborative partners",
"REFERENCES"
] |
NCT01799993 | 1 | Title Page - amended | 1. Title Page - amended A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia Test Drug: BAY 41-6551 (Amikacin Solution for Inhalation and the ... | [
"Confidential",
"Signature of the sponsor's medically responsible persons [3](#page-3-1)",
"Signature of the principal investigator"
] |
NCT01799993 | 2 | Synopsis - amended | 2. Synopsis - amended | Title | A Prospective, Randomized, Double-Blind, Placebo-Controlled,Multicenter Study to Evaluate the Safety and Efficacy ofBAY41-6551 as Adjunctive Therapy in Intubated andMechanically-Ventilated Patients with Gram-Negative Pneumonia | | |--------------------------------------------------------... | [
"Safety variables All patients who have received at least one dose of the study drug(s) will be evaluated for safety in a descriptive manner. The safety analysis will include tabulation of the type (using Medical Dictionary for Regulatory Activities [MedDRA] glossary) and frequency of all AEs. Drug-related AEs, ser... |
NCT01799993 | 4 | Glossary and Abbreviations [15](#page-14-1) - amended | 4. Glossary and Abbreviations [15](#page-14-1) - amended AARC American Association for Respiratory Care AC/DC adaptor alternating current/direct current adaptor AE Adverse event ALT alanine aminotransferase ANC Absolute neutrophil count AP Aeroneb Pro APACHE II Acute Physiology and Chronic Health Evaluation II ARDS Acu... | [] |
NCT01799993 | 5 | Introduction | 5. Introduction | [] |
NCT01799993 | 5.1 | Background and Rationale - amended | 5.1 Background and Rationale - amended Amikacin is a well-known aminoglycoside antibiotic used intravenously (IV) or intramuscularly (IM) for the treatment of infections caused by Gram-negative bacteria. Its spectrum of activity makes it suitable for use in nosocomial pneumonia patients where Gram-negative organisms ar... | [] |
NCT01799993 | 5.2 | Risk Factors | 5.2 Risk Factors The incidence of NP is associated with many factors, with mechanical ventilation and the duration of ventilation being primary causes of HAP, VAP, or HCAP occurrence. NP was associated with mechanical ventilation in 86% of cases in one study, and the risk for acquiring VAP increased from 5% in patients... | [] |
NCT01799993 | 5.3 | Bacteriology | 5.3 Bacteriology The identification of microorganisms reported to be responsible for HAP, VAP, and HCAP varied substantially across different institutions, and was affected by factors such as underlying disease, previous antibiotic use, diagnostic methods, and local patterns of antibiotic-resistant organisms. Hospital-... | [] |
NCT01799993 | 5.4 | Aerosolized Antibiotic Therapy | 5.4 Aerosolized Antibiotic Therapy | [] |
NCT01799993 | 5.4.1 | Animal Studies | 5.4.1 Animal Studies Accumulation of amikacin was observed in the rat lung after 14 consecutive days of noseonly inhalation exposure ranging from 20 to 109 mg/kg/day total inhaled nebulized amikacin (data on file, Bayer Report PH 36378, AT06142). Amikacin (548 μg/g 1.13) was detected in lung tissue, but not plasma afte... | [] |
NCT01799993 | 5.4.2 | Human Studies - amended | 5.4.2 Human Studies - amended Aerosolized antibiotics have been administered to critically ill patients to treat pulmonary infections in hospitalized patients and have been investigated in clinical studies for the prevention and treatment of pneumonia in hospitalized patients.[3](#page-76-6)[,24](#page-77-7) The advant... | [] |
NCT01799993 | 6 | Study Objectives - amended | 6. Study Objectives - amended [19](#page-20-2)The study objective is to demonstrate that as adjunctive therapy to IV antibiotics, BAY 41- 6551 400 mg (amikacin as free base) administered as an aerosol by the PDDS Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as... | [] |
NCT01799993 | 7 | Investigators and Other Study Participants - amended | 7. Investigators and Other Study Participants - amended [20](#page-21-1)The The role of the coordinating investigator has been assigned to Michael S. Niederman, MD, New York-Presbyterian University Hospital of Columbia and Cornell, PPD PPD Bayer will utilize an independent Data Monitoring Committee (DMC) to oversee thi... | [] |
NCT01799993 | 8 | Investigational Plan | 8. Investigational Plan | [] |
NCT01799993 | 8.1 | Study Design - amended | 8.1 Study Design - amended This is a Phase III, prospective, randomized, double-blind, placebo-controlled, multicenter, multinational study designed to show that aerosolized BAY 41-6551 400 mg (amikacin as free base) every 12 hours is more effective than placebo (aerosolized normal saline), as 22 Paragraph added per Am... | [] |
NCT01799993 | 8.2 | Study Plan - amended | 8.2 Study Plan - amended Patients who have met all of the inclusion criteria and none of the exclusion criteria will be stratified by geographic region (or country) and disease severity using the Acute Physiology and Chronic Health Evaluation (APACHE II) score (Stratum I: APACHE II score 23 Paragraph revised with Amend... | [] |
NCT01799993 | 8.3 | Selection of Study Population - amended | 8.3 Selection of Study Population - amended [33](#page-25-2)Patients of age 18 and older, who are hospitalized, have pneumonia suspected or confirmed to be caused by Gram-negative organisms, and who are intubated and mechanicallyventilated will be selected for this study. In all patients where the pathogen is suspected... | [] |
NCT01799993 | 8.3.1 | Inclusion Criteria - amended | 8.3.1 Inclusion Criteria - amended A patient must meet all of the following inclusion criteria to be eligible to participate in the study: - 1) Males and non-pregnant, non-lactating females, 18 years of age or older. For females of child-bearing potential, one of the following medically acceptable contraceptive methods... | [] |
NCT01799993 | 8.3.2 | Exclusion Criteria - amended | 8.3.2 Exclusion Criteria - amended A patient who meets any of the following exclusion criteria will be excluded from study participation: - 1) A history of hypersensitivity to amikacin or other aminoglycosides - 2) Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours[39](#page-27-2) at ... | [] |
NCT01799993 | 8.3.3 | Discontinuation of Patients | 8.3.3 Discontinuation of Patients Patients may prematurely discontinue study drug and/or prematurely discontinue or terminate from the study for a number of reasons. The reason(s) for premature discontinuation or termination should be clearly stated in the CRF. A follow-up contact will be arranged as appropriate. At th... | [] |
NCT01799993 | 8.3.3.1 | Reasons for Premature Discontinuation of Study Drug - amended | 8.3.3.1 Reasons for Premature Discontinuation of Study Drug - amended Since study drug is provided only as an adjunctive therapy and not the primary treatment for the patient's Gram-negative pneumonia, every effort should be made to allow patients to complete a full course of inhaled study drug to determine the impact ... | [] |
NCT01799993 | 8.3.3.2 | Reasons for Premature Discontinuation from the Study | 8.3.3.2 Reasons for Premature Discontinuation from the Study - Lost to follow-up - Withdrawal of consent - At the specific request of the sponsor | [] |
NCT01799993 | 8.3.3.3 | Premature Termination of Study/Closure of Center | 8.3.3.3 Premature Termination of Study/Closure of Center The sponsor has the right to close this study, and the investigator/sponsor has the right to close a study center, at any time, although this should occur only after consultation between involved parties. The IEC/IRB must be informed. Should the study/center be c... | [] |
NCT01799993 | 8.4 | Treatments | 8.4 Treatments | [] |
NCT01799993 | 8.4.1 | Treatments to be Administered - amended | 8.4.1 Treatments to be Administered - amended [47](#page-30-4)Treatment will consist of standard of care IV antibiotics for intubated patients with Gramnegative pneumonia with consideration to include 2 antibiotics as per the 2005 ATS/ IDSA Guidelines, plus aerosolized BAY 41-6551 or aerosolized placebo (Section [8.2](... | [] |
NCT01799993 | 8.4.1.1 | Antibiotic Selection | 8.4.1.1 Antibiotic Selection | [] |
NCT01799993 | 8.4.1.1.1 | Initial Empiric Antibiotic Therapy - amended | 8.4.1.1.1 Initial Empiric Antibiotic Therapy - amended In cases where specific bacterial pathogens from the respiratory tract have not yet been positively identified[48](#page-31-2), the selection of the initial IV antibiotic regimen will be empiric and based on several factors including the patient's allergy history, ... | [] |
NCT01799993 | 8.4.1.1.2 | HAP, VAP, or HCAP in Patients with Late Onset Disease or Risk Factors for MDR Pathogens and All Disease Severity | 8.4.1.1.2 HAP, VAP, or HCAP in Patients with Late Onset Disease or Risk Factors for MDR Pathogens and All Disease Severity Patients at risk for infection with Pseudomonas aeruginosa, Acinetobacter species, Klebsiella pneumoniae, Enterobacter species, and methicillin-resistant Staphylococcus aureus (MRSA) should initial... | [
"Table 1: Initial Empiric Antibiotic Therapy – For Patients With Late-Onset Disease or Risk Factors for MDR Pathogens"
] |
NCT01799993 | 8.4.1.1.3 | Initial Intravenous, Adult Doses of Antibiotics | 8.4.1.1.3 Initial Intravenous, Adult Doses of Antibiotics Table 2: Initial Intravenous, Adult Doses of Antibiotics for Empiric Therapy | Antibiotic | Dosage a | |--------------------------------|----------------------------------| | Antipseudomonal cephalosporin | | | Cefepime | 1–2 g every 8–12 h | | Ceftazidime | 2 g... | [] |
NCT01799993 | 8.4.1.1.4 | Adjustment of Empiric Intravenous Antibiotic Therapy - amended | 8.4.1.1.4 Adjustment of Empiric Intravenous Antibiotic Therapy - amended It is not uncommon for the initial empiric therapy recommendations to require adjustment once the results of respiratory tract and blood cultures become available. Therapy can often be de-escalated (fewer antibiotics) or additional agents included... | [] |
NCT01799993 | 8.4.2 | Identity of Investigational Products | 8.4.2 Identity of Investigational Products For this study, BAY 41-6551 inhalation solution will be supplied to clinical sites as a preservative-free sterile solution, which has been labeled for clinical study use. > Active Ingredient: Amikacin sulfate 1:1.8 Pharmacologic Class: aminoglycoside antibiotic Molecular Formu... | [] |
NCT01799993 | 8.4.3 | Method of Assigning Patients to Treatment Groups - amended | 8.4.3 Method of Assigning Patients to Treatment Groups - amended All patients who meet the enrollment criteria will be stratified based on geographic region (or country) [52](#page-35-3) and disease severity (as determined by the APACHE II score calculated at the time the patient is evaluated for entry into the study a... | [] |
NCT01799993 | 8.4.4 | Selection of Doses in the Study | 8.4.4 Selection of Doses in the Study The dose of study drug is 400 mg (amikacin as free base) BAY 41-6551 or 3.2 mL of placebo every 12 hours administered by inhalation (Section [5.4.2](#page-19-0)). | [] |
NCT01799993 | 8.4.5 | Administration and Dosing Regimen - amended | 8.4.5 Administration and Dosing Regimen - amended Dosing of BAY 41-6551 by inhalation will be every 12 hours for ten full days according to Table 4. All investigators should be aware that 400 mg every 12 hours dose of aerosolized BAY 41-6551 refers to the quantity of amikacin free base in BAY 41-6551 Solution (Amikacin... | [] |
NCT01799993 | 8.4.6 | Dose Modification | 8.4.6 Dose Modification | [] |
NCT01799993 | 8.4.6.1 | Renal Impairment - amended | 8.4.6.1 Renal Impairment - amended Dosing for both IV and aerosol treatments may require modification based on the patient's renal function as measured by serum creatinine and urine output. It may also be necessary to modify the dosage regimen of aerosol therapy if there is evidence of bronchospasm during administratio... | [] |
NCT01799993 | 8.4.6.2 | Bronchospasm | 8.4.6.2 Bronchospasm If, in the opinion of the investigator or sub-investigator(s), the patient experiences an acute onset of bronchospasm, the patient may be treated prophylactically with a bronchodilator according to clinical judgment prior to each subsequent dose of aerosol treatment, and the patient may remain on s... | [] |
NCT01799993 | 8.5 | Pulmonary Drug Delivery System (PDDS Clinical) | 8.5 Pulmonary Drug Delivery System (PDDS Clinical) | [] |
NCT01799993 | 8.5.1 | Identity of Device - amended | 8.5.1 Identity of Device - amended The PDDS Clinical is a single patient, single-dose drug delivery system, designed to deliver aerosolized medication for patients during mechanical ventilation and after extubation in the course of clinical investigation. The PDDS Clinical will be used with the inline T-piece for use d... | [] |
NCT01799993 | 8.5.2 | Ventilator Settings | 8.5.2 Ventilator Settings The PDDS Clinical is designed for use with standard, adult ventilator settings. An intermittent positive pressure ventilatory mode is required to activate the PDDS Clinical to deliver aerosol during inspiration (refer to the PDDS Clinical Instruction Manual). A heat-moisture exchanger (HME) ma... | [] |
NCT01799993 | 8.5.3 | Device Supply – amended | 8.5.3 Device Supply – amended Prior to the first aerosolized dose of BAY 41-6551, one PDDS Clinical will be dispensed. The serial numbers for the PDDS Clinical control module and the lot number of the nebulizer/reservoir will be recorded in the dispensing log. During the 10-day treatment period, one control module will... | [] |
NCT01799993 | 8.5.4 | Device Replacement | 8.5.4 Device Replacement Devices for intubated and non-intubated patients may be replaced at any time if there is a suspicion of malfunction, but must be replaced if the investigator suspects the device is not performing optimally for any reason. | [] |
NCT01799993 | 8.5.5 | Device Malfunction or Failure | 8.5.5 Device Malfunction or Failure If any of the devices need to be replaced, the reason(s) will be documented in the patient's device accountability record. Additional PDDS Clinical devices are provided for this purpose. The unique serial number of the new PDDS Clinical control module and lot number for the nebulizer... | [] |
NCT01799993 | 8.6 | Blinding/Unblinding - amended | 8.6 Blinding/Unblinding - amended The decision to unblind is the principal investigator's. The Medical Expert is available to discuss the need to unblind any patient, and can be contacted if needed.[59](#page-40-5) Unblinding should only occur in the event of an emergency. Investigators should note that the occurrence ... | [] |
NCT01799993 | 8.7 | Prior and Concomitant Medication | 8.7 Prior and Concomitant Medication Patients are excluded if they have received another experimental drug within the previous 28 days. Concomitant or sequential use of IV, oral, or topical nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paramomycin, viomycin, polymyxin B, colis... | [] |
NCT01799993 | 8.8 | Treatment Compliance | 8.8 Treatment Compliance At all appropriate assessment periods or visits, the investigator or other study personnel will note in the CRF whether treatment has been administered, as directed in the protocol, during the preceding interval. If not, the date and reason for each deviation must be recorded. All efforts will ... | [] |
NCT01799993 | 9 | Study Procedures | 9. Study Procedures | [] |
NCT01799993 | 9.1 | Schedule of Visits and Visit Specific Procedures and Assessments | 9.1 Schedule of Visits and Visit Specific Procedures and Assessments | [] |
NCT01799993 | 9.1.1 | Screening Period (48 Hours Prior to Randomization) | 9.1.1 Screening Period (48 Hours Prior to Randomization) Potential study patients will be recruited by the study staff among hospitalized patients with a clinical diagnosis of pneumonia who have been intubated and mechanically-ventilated (patients who have had a tracheotomy may be considered as possible study participa... | [] |
NCT01799993 | 9.1.2 | Treatment Period (Day 1 to Day 10) - amended | 9.1.2 Treatment Period (Day 1 to Day 10) - amended Day 1 is defined as the day the initial dose of study medication (aerosolized BAY 41-6551 or aerosolized placebo[61](#page-43-2)) is given. Day 1 may be the same day as when the informed consent form (ICF) is signed, screening assessments are performed, and the patient... | [] |
NCT01799993 | 9.1.2.1 | Assessments Performed Daily - amended | 9.1.2.1 Assessments Performed Daily - amended Patients will have the following assessments and procedures performed daily, unless otherwise indicated, during the treatment period: - A physical examination including vital signs - An assessment of clinical signs and symptoms of pneumonia 62 24 hours changed to 48 hours w... | [] |
NCT01799993 | 9.1.2.2 | Assessments Performed on Days 1, 3, 5, and 7 - amended | 9.1.2.2 Assessments Performed on Days 1, 3, 5, and 7 - amended [65](#page-44-1)Patients will have the following assessments and procedures performed on Days 1, 3, 5, and 7 during the treatment period as indicated: CXR obtained NOTE: the reading and interpretation of the CXR by the investigator and/or subinvestigator(s)... | [] |
NCT01799993 | 9.1.3 | Post-Treatment Period (Days 10-32) | 9.1.3 Post-Treatment Period (Days 10-32) | [] |
NCT01799993 | 9.1.3.1 | End of Therapy Visit (Day 10) - amended | 9.1.3.1 End of Therapy Visit (Day 10) - amended The end of therapy (EOT) visit will be conducted on Day 10 or within 24 hours after completion of study drug. The Investigator Assessment of Patient Outcome will involve an evaluation of clinical signs and symptoms.[66](#page-45-2) Patients will have the following assessm... | [] |
NCT01799993 | 9.1.3.2 | Test-of-Cure (TOC) Visit (Days 17 - 19) - amended | 9.1.3.2 Test-of-Cure (TOC) Visit (Days 17 - 19) - amended The TOC visit will be conducted on Days 17-19 of the study. The Investigator Assessment of Patient Outcome will be determined by an assessment of clinical signs and symptoms.[68](#page-46-1) Patients will have the following assessments and procedures performed d... | [] |
NCT01799993 | 9.1.3.3 | Late Follow-Up Visit (Days 28 - 32) - amended | 9.1.3.3 Late Follow-Up Visit (Days 28 - 32) - amended The LFU visit will be conducted on Days 28 – 32 of the study. Patients will be strongly encouraged to return to their study facility for their LFU visit. However, if this is not feasible all obtainable information can be collected by telephone from the patient or th... | [] |
NCT01799993 | 9.2 | Completion of Study | 9.2 Completion of Study A patient is considered to have completed the study when they have completed the treatment period and both post-treatment follow-up visits (eg, TOC and LFU visit). | [] |
NCT01799993 | 9.3 | Follow-Up Assessments | 9.3 Follow-Up Assessments Follow-up assessments will be obtained as needed to monitor any SAE until the event resolves or is considered to be stable and non-resolving. Hearing loss should be noted on the CRF. | [] |
NCT01799993 | 9.4 | Unscheduled Assessments or Visits | 9.4 Unscheduled Assessments or Visits The investigator is responsible for monitoring patients for any treatment-related toxicity. Blood samples for clinical laboratory tests may be drawn at any time at the discretion of the investigator. Samples obtained at unscheduled times will be sent to the local laboratory for ana... | [] |
NCT01799993 | 9.5 | Premature Discontinuation / Early Withdrawal from Study - amended | 9.5 Premature Discontinuation / Early Withdrawal from Study - amended Patients prematurely discontinuing or withdrawing early from the study, for whatever reason, will be asked to undergo the following evaluations at the time of discontinuation / withdrawal: - Complete physical examination, including vital signs; in ad... | [] |
NCT01799993 | 9.6 | Study Measurements | 9.6 Study Measurements The objective of this study is to evaluate the efficacy and safety of adjunctive aerosolized BAY 41-6551 in the treatment of intubated and mechanically-ventilated adult patients with Gram-negative pneumonia. | [] |
NCT01799993 | 9.6.1 | Efficacy Variables – amended | 9.6.1 Efficacy Variables – amended | [] |
NCT01799993 | 9.6.1.1 | Primary Efficacy Variable: Survival - amended | 9.6.1.1 Primary Efficacy Variable: Survival - amended [74](#page-49-4)The primary efficacy variable is Survival, which is determined by tabulating the cumulative mortality and survival through the LFU visit for each mITT patient. Survival (and mortality) is the only criteria evaluated for the primary endpoint, no other... | [] |
NCT01799993 | 9.6.1.2 | Additional Analysis of Clinical Success - amended | 9.6.1.2 Additional Analysis of Clinical Success - amended [75](#page-49-5)There are three additional analyses of clinical success. These three analyses are separate from the primary endpoint. The three analyses are (1) the FNIH recommendations for an endpoint based on mortality plus septic shock, (2) the Investigator's... | [] |
NCT01799993 | 9.6.1.2.1 | FNIH Criteria - amended | 9.6.1.2.1 FNIH Criteria - amended [76](#page-49-6)Clinical success using FNIH recommendations is defined as mITT patients who survived through the LFU visit and did not have septic shock. Patients will be designated as having a septic shock event based on the standard medical queries (SMQ) terms tabulated as adverse ev... | [] |
NCT01799993 | 9.6.1.2.2 | Investigator Assessment of Patient Outcome - amended | 9.6.1.2.2 Investigator Assessment of Patient Outcome - amended [77](#page-50-0) The investigators will also assess patient outcome based on a composite endpoint. The Investigator Assessment of Patient Outcome is separate and different from the primary endpoint of Survival, which is done by using a computer algorithm ba... | [] |
NCT01799993 | 9.6.1.2.2 | 1End of Therapy (Day 10) | 9.6.1.2.2.1End of Therapy (Day 10) [78](#page-50-1)The Investigator Assessment of Patient Outcome will be evaluated at the EOT visit using the following terms and definition.
Investigator Assessment of Patient Outcome - Cure: - Improvement or lack of progression of all abnormalities associated with pneumonia on chest ... | [
"Investigator Assessment of Patient Outcome - Cure:",
"Investigator Assessment of Patient Outcome - Failure:"
] |
NCT01799993 | 9.6.1.2.2 | 2Test-of-Cure (TOC) Visit (Day 17-19) - amended | 9.6.1.2.2.2Test-of-Cure (TOC) Visit (Day 17-19) - amended [81](#page-51-2)The Investigator Assessment of Patient Outcome will be evaluated at the TOC visit using the following terms and definitions:
Investigator Assessment of Patient Outcome - Cure: - Improvement or lack of progression of all abnormalities associated ... | [
"Investigator Assessment of Patient Outcome - Cure:",
"Investigator Assessment of Patient Outcome - Failure:"
] |
NCT01799993 | 9.6.1.2.2 | 3Late Follow-up Visit (Days 28 – 32) – amended | 9.6.1.2.2.3Late Follow-up Visit (Days 28 – 32) – amended [84](#page-53-0)The Investigator Assessment of Patient Outcome will be evaluated at the LFU visit. As mentioned previously, a patient evaluated at the TOC visit as a patient outcome failure will have that response carried forward to the LFU visit. For patients wh... | [] |
NCT01799993 | 9.6.1.2.2 | 4Premature Discontinuation Visit - amended | 9.6.1.2.2.4Premature Discontinuation Visit - amended [85](#page-53-1)A patient may not complete a full 10-day (20 doses) course of study drug treatment or may not reach the TOC visit (Days 17-19). These patients may prematurely discontinue therapy because they are failing study treatment and alternative antibiotic ther... | [
"Investigator Assessment of Patient Outcome - Failure:"
] |
NCT01799993 | 9.6.1.2.3 | Composite Endpoint Evaluation: - amended | 9.6.1.2.3 Composite Endpoint Evaluation: - amended [86](#page-55-1)An evaluation of patient outcome based on 5 components is determined by using a computer algorithm based on collected data and specific criteria. This assessment based on 5 criteria is separate and different from the Primary Endpoint of Survival. For a ... | [
"Stable respiratory function:",
"Unstable respiratory function"
] |
NCT01799993 | 9.6.2 | Safety Variables | 9.6.2 Safety Variables All patients who have received at least one dose of the study drug(s) will be evaluated for safety in a descriptive manner. The safety analysis will include tabulation of the type (using Medical Dictionary for Regulatory Activities [MedDRA] glossary) and frequency of all AEs. 86 Per Amendment 8 !... | [] |
NCT01799993 | 9.6.2.1 | Clinical Laboratory Tests | 9.6.2.1 Clinical Laboratory Tests The following clinical laboratory tests will be performed (Section [15.1](#page-80-0)): - Hematology: hemoglobin, hematocrit, WBC with differential (%), red blood cell (RBC) count, platelet count - Chemistry: alkaline phosphatase, alanine aminotransferase/serum glutamate pyruvate trans... | [] |
NCT01799993 | 9.6.2.2 | Bacteriological Response Assessments | 9.6.2.2 Bacteriological Response Assessments Bacteriological response will be based on the results of the appropriate cultures taken before, during, and after therapy. For infections caused by two or more pathogens, the response for each organism will be assessed separately. 87 Revised per Amendment 8  Visit (Days 17-19) | 9.6.2.2.1 Test-of-Cure (TOC) Visit (Days 17-19) The bacteriological response at the TOC visit will be graded as follows: - Eradication: the absence of the original pathogen(s) at the post-treatment TOC culture of specimens from the original site of infection - Presumed eradication: absence of appropriate culture materi... | [] |
NCT01799993 | 9.6.2.2.2 | Late Follow-up Visit (Days 28-32) | 9.6.2.2.2 Late Follow-up Visit (Days 28-32) Continued Eradication: the absence of the original pathogen(s) at the post-treatment late follow-up culture of specimens from the original site of infection. Continued Presumed Eradication: absence of appropriate culture material for evaluation because the patient's pneumonia... | [] |
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