protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT04126031 | 5.8 | Oral Switch Therapy | 5.8. Oral Switch Therapy Subjects in Part B may be switched to oral therapy after at least 48 hours of IV CAZ-AVI if the subject has a good or sufficient clinical response and is tolerating oral fluids or food. The decision to switch to oral therapy is entirely at the Investigator's discretion. If subjects are switched... | [] |
NCT04126031 | 5.9 | Intravenous Switch Therapy | 5.9. Intravenous Switch Therapy In rare situations it may be appropriate to discharge subjects in Part B to continue outpatient parenteral antimicrobial therapy (OPAT) at home. The decision to switch to OPAT is entirely at the Investigator's discretion, but subjects cannot continue to receive the CAZ-AVI study drug out... | [] |
NCT04126031 | 5.10 | Concomitant Treatment(s) | 5.10. Concomitant Treatment(s) Use of potent inhibitors of organic anion transporters OAT1 and/or OAT3 (eg, probenecid, p-aminohippuric acid (PAH), or teriflunomide) are prohibited during the study because they have the potential to alter (decrease) the clearance of avibactam when coadministered. This prohibition on th... | [] |
NCT04126031 | 6 | STUDY PROCEDURES | 6. STUDY PROCEDURES Study periods are defined in [Figure 1](#page-25-0). Details of the study plan and procedures are provided in the [SCHEDULE OF ACTIVITIES](#page-14-0) and are described in detail by visit in the following sections. | [] |
NCT04126031 | 6.1 | Screening and Enrollment | 6.1. Screening and Enrollment Prior to any study specific procedures, the subject's parent or parents (depending on local requirements) or legally acceptable representative must provide written informed consent. During the screening period, subjects will be assessed regarding eligibility criteria. Subjects who do not m... | [] |
NCT04126031 | 6.1.1 | Visit 1: Eligibility/Screening Procedures (Day -1 to 1) | 6.1.1. Visit 1: Eligibility/Screening Procedures (Day -1 to 1) Each subject will undergo Screening assessment procedures on the day of or one day prior to the first dose of CAZ-AVI as outlined in the [SCHEDULE OF ACTIVITIES.](#page-14-0) Screening assessments can serve as baseline if they are completed on the same cale... | [] |
NCT04126031 | 6.1.1.1 | Clinical Assessments | 6.1.1.1. Clinical Assessments - 1. Obtain informed consent. - 2. Review the inclusion and exclusion criteria. - 3. Obtain a complete medical history, including, but not limited to, history of delivery, antepartum and peripartum antibacterials, vaccinations, congenital abnormalities, surgeries, and all conditions diagno... | [] |
NCT04126031 | 6.1.1.2 | Laboratory Assessments | 6.1.1.2. Laboratory Assessments - 1. Obtain blood samples for complete blood count (CBC) with differential and chemistry panel (see Laboratory Manual). For Part A, if the subject is improving and laboratory assessments were performed within 2 days of CAZ-AVI infusion, those test results may be used for eligibility and ... | [] |
NCT04126031 | 6.1.1.3 | Microbiological Assessments (Part B Only) | 6.1.1.3. Microbiological Assessments (Part B Only) - 1. If clinically indicated and performed as part of subject's regular medical care, obtain blood culture for testing per [Section 7.3.1;](#page-54-0) cultures should be repeated per standard of care upon knowledge of a positive result until sterilization is confirmed... | [] |
NCT04126031 | 6.2 | Study Period | 6.2. Study Period | [] |
NCT04126031 | 6.2.1 | Visit 2, Study Day 1 | 6.2.1. Visit 2, Study Day 1 Study Day 1 is the day of the first administration of study therapy. | [] |
NCT04126031 | 6.2.1.1 | Study Therapy Administration | 6.2.1.1. Study Therapy Administration - 1. Infusion of CAZ-AVI IV over a 2-hour (10 min) period, according to the cohort as indicated in [Table](#page-34-1) 2. The dose should be calculated based on the subject's first weight of the day on the starting day unless the local standard practice for neonatal weight-based do... | [] |
NCT04126031 | 6.2.1.2 | Clinical Assessments | 6.2.1.2. Clinical Assessments - 1. Identify, assess, and record any new or ongoing AEs or SAEs. - 2. Record concomitant medications including, but not limited to, all antimicrobials, parenteral nutrition, and blood and blood component transfusions. For subjects who are being breast fed, record all medications taken by ... | [] |
NCT04126031 | 6.2.1.3 | Laboratory Assessments | 6.2.1.3. Laboratory Assessments - 1. If clinically indicated, prior to the start of the infusion, obtain blood samples for CBC with differential and chemistry panel (see Laboratory Manual). - 2. Part B Only: If clinically indicated and if blood gases are available, calculate base excess (BE) using the formula: BE = $$0... | [] |
NCT04126031 | 6.2.1.4 | Microbiological Assessments (Part B Only) | 6.2.1.4. Microbiological Assessments (Part B Only) - 1. If clinically indicated and performed as part of subject's regular medical care, obtain blood culture for testing per [Section 7.3.1;](#page-54-0) cultures should be repeated per standard of care upon knowledge of a positive result until sterilization is confirmed... | [] |
NCT04126031 | 6.2.1.5 | PK Procedures – Part A Only | 6.2.1.5. PK Procedures – Part A Only Following the infusion of CAZ-AVI, blood samples for PK (0.3 mL per sample) will be collected at the following time points: 1) anytime within 15 minutes after stopping CAZ-AVI infusion, 2) anytime between 30 minutes and 90 minutes after stopping CAZ-AVI infusion, and 3) anytime betw... | [] |
NCT04126031 | 6.2.2 | Visit 3, Study Day 2: Part A Only | 6.2.2. Visit 3, Study Day 2: Part A Only | [] |
NCT04126031 | 6.2.2.1 | Clinical Assessments | 6.2.2.1. Clinical Assessments - 1. Identify, assess, and record any new or ongoing AEs or SAEs. - 2. Record concomitant medications including, but not limited to, all antimicrobials, parenteral nutrition, and blood and blood component transfusions. For subjects who are being breast fed, record all medications taken by ... | [] |
NCT04126031 | 6.2.2.2 | Laboratory Assessments | 6.2.2.2. Laboratory Assessments - 1. Obtain blood samples for complete blood count (CBC) with differential and chemistry panel (see Laboratory Manual). - 2. Perform urinalysis (see Laboratory Manual). - 3. Calculate urine output over the last 8 hour period. | [] |
NCT04126031 | 6.2.3 | Visit 4, Study Day 3: Part A Only | 6.2.3. Visit 4, Study Day 3: Part A Only | [] |
NCT04126031 | 6.2.3.1 | Clinical Assessments | 6.2.3.1. Clinical Assessments - 1. Identify, assess, and record any new or ongoing AEs or SAEs. - 2. Record concomitant medications including, but not limited to, all antimicrobials, parenteral nutrition, and blood and blood component transfusions. For subjects who are being breast fed, record all medications taken by ... | [] |
NCT04126031 | 6.2.3.2 | Laboratory Assessments | 6.2.3.2. Laboratory Assessments - 1. If clinically indicated, obtain blood samples for complete blood count (CBC) with differential and chemistry panel (see Laboratory Manual). - 2. If clinically indicated, perform urinalysis (see Laboratory Manual). | [] |
NCT04126031 | 6.2.4 | Visits 3-15, Study Days 2-14: Part B Only | 6.2.4. Visits 3-15, Study Days 2-14: Part B Only | [] |
NCT04126031 | 6.2.4.1 | Study Therapy Administration | 6.2.4.1. Study Therapy Administration - 1. Infusion of CAZ-AVI IV over a 2-hour (10 min) period q8h, according to the cohort as indicated in [Table](#page-34-1) 2. The CAZ-AVI dose in Part B should not be adjusted based on fluctuations in daily weight, and it should remain the same throughout the dosing period up to 14... | [] |
NCT04126031 | 6.2.4.2 | Clinical Assessments | 6.2.4.2. Clinical Assessments - 1. Identify, assess, and record any new or ongoing AEs or SAEs. - 2. Record concomitant medications including, but not limited to, all antimicrobials, parenteral nutrition, and blood and blood component transfusions. For subjects who are being breast fed, record all medications taken by ... | [] |
NCT04126031 | 6.2.4.3 | Laboratory Assessments | 6.2.4.3. Laboratory Assessments - 1. If clinically indicated, obtain blood samples for CBC with differential and chemistry panel (see Laboratory Manual). - 2. If clinically indicated and if blood gases are available, calculate base excess (BE) using the formula: BE = $$0.02786 pCO2 10^{(pH - 6.1)} + 13.77 pH - 124.58$$... | [] |
NCT04126031 | 6.2.4.4 | Microbiological Assessments | 6.2.4.4. Microbiological Assessments - 1. If clinically indicated and performed as part of subject's regular medical care, obtain blood culture for testing per [Section 7.3.1;](#page-54-0) cultures should be repeated per standard of care upon knowledge of a positive result until sterilization is confirmed. - 2. If clin... | [] |
NCT04126031 | 6.2.4.5 | PK Procedures | 6.2.4.5. PK Procedures Do not draw PK blood samples if the subject received a blood or blood component transfusion within the past 24 hours. For subjects who are at risk from additional blood loss, collection of PK samples will require assessment by the Investigator. Obtain 3 single PK blood samples between the end of ... | [] |
NCT04126031 | 6.2.5 | End of IV (EOIV): Part B Only | 6.2.5. End of IV (EOIV): Part B Only EOIV assessments should be performed within 24 hours after completion of the last infusion of CAZ-AVI or at the time of premature discontinuation of CAZ-AVI or early withdrawal from study (if on IV therapy). The EOIV assessments should be conducted in place of the regular study visi... | [] |
NCT04126031 | 6.2.5.1 | Clinical Assessments | 6.2.5.1. Clinical Assessments - 1. Identify, assess, and record any new or ongoing AEs or SAEs. - 2. Record concomitant medications including, but not limited to, all antimicrobials, parenteral nutrition, and blood and blood component transfusions. For subjects who are being breast fed, record all medications taken by ... | [] |
NCT04126031 | 6.2.5.2 | Laboratory Assessments | 6.2.5.2. Laboratory Assessments - 1. Obtain blood samples for complete blood count (CBC) with differential and chemistry panel (see Laboratory Manual). - 2. If clinically indicated and if blood gases are available, calculate base excess (BE) using the formula: BE = $$0.02786 pCO2 10^{(pH - 6.1)} + 13.77 pH - 124.58$$ -... | [] |
NCT04126031 | 6.2.5.3 | Oral Switch Therapy Administration | 6.2.5.3. Oral Switch Therapy Administration Administer oral switch therapy as appropriate per Investigator discretion. | [] |
NCT04126031 | 6.2.5.4 | Microbiological Assessments | 6.2.5.4. Microbiological Assessments - 1. If clinically indicated and performed as part of subject's regular medical care, obtain blood culture for testing per [Section 7.3.1;](#page-54-0) cultures should be repeated per standard of care upon knowledge of a positive result until sterilization is confirmed. - 2. If clin... | [] |
NCT04126031 | 6.2.6 | End of Treatment (Oral or OPAT): Part B Only | 6.2.6. End of Treatment (Oral or OPAT): Part B Only The assessments at EOT should be performed within 48 hours after the last dose of oral or OPAT switch therapy or at the time of premature discontinuation of oral or OPAT switch therapy or early withdrawal from study (if on oral or OPAT switch therapy). If a subject do... | [] |
NCT04126031 | 6.2.6.1 | Laboratory Assessments | 6.2.6.1. Laboratory Assessments - 1. If clinically indicated, obtain blood samples for complete blood count (CBC) with differential and chemistry panel (see Laboratory Manual). - 2. If clinically indicated and if blood gases are available, calculate base excess (BE) using the formula: BE = $$0.02786 pCO2 10^{(pH - 6.1)... | [] |
NCT04126031 | 6.2.6.2 | Microbiological Assessments | 6.2.6.2. Microbiological Assessments 1. If clinically indicated and performed as part of subject's regular medical care, obtain blood culture for testing per [Section 7.3.1;](#page-54-0) cultures should be repeated per standard of care upon knowledge of a positive result until sterilization is confirmed. - 2. If clinic... | [] |
NCT04126031 | 6.2.7 | Test of Cure (TOC): Part B Only | 6.2.7. Test of Cure (TOC): Part B Only Conduct TOC assessments 7 to 14 days after administration of the last dose of study therapy (IV or oral). If a subject was previously assessed as a clinical failure, only the safety assessments need to be performed (ie, AEs and SAEs, concomitant medications, adjunctive therapeutic... | [] |
NCT04126031 | 6.2.7.1 | Clinical Assessments | 6.2.7.1. Clinical Assessments - 1. Identify, assess, and record any new or ongoing AEs or SAEs. - 2. Record concomitant medications including, but not limited to, all antimicrobials, parenteral nutrition, and blood and blood component transfusions. For subjects who are being breast fed, record all medications taken by ... | [] |
NCT04126031 | 6.2.7.2 | Laboratory Assessments | 6.2.7.2. Laboratory Assessments - 1. If clinically indicated, obtain blood samples for CBC with differential and chemistry panel (see Laboratory Manual). - 2. If clinically indicated, perform urinalysis (see Laboratory Manual). - 3. If clinically indicated, calculate urinary output over the last 8 hour period. | [] |
NCT04126031 | 6.2.7.3 | Microbiological Assessments | 6.2.7.3. Microbiological Assessments - 1. If clinically indicated and performed as part of subject's regular medical care, obtain blood culture for testing per [Section 7.3.1;](#page-54-0) cultures should be repeated per standard of care upon knowledge of a positive result until sterilization is confirmed. - 2. If clin... | [] |
NCT04126031 | 6.2.8 | Late Follow-Up (LFU) | 6.2.8. Late Follow-Up (LFU) | [] |
NCT04126031 | 6.2.8.1 | Part A | 6.2.8.1. Part A Follow-up contact will be completed at least 28 calendar days, and up to 35 calendar days after infusion of CAZ-AVI to capture any potential adverse events or serious adverse events. Contact with the subject's parent(s)/legal guardian/legally acceptable representative may be conducted via a telephone ca... | [] |
NCT04126031 | 6.2.8.2 | Part B | 6.2.8.2. Part B Conduct LFU assessments, preferably in person, 28 to 35 days after the last dose of IV CAZ-AVI. The LFU may be conducted via telephone for any subject who has not experienced clinical relapse, did not have ongoing AEs or SAEs at TOC, or did not develop AEs or SAEs since TOC. If symptoms of relapse or ne... | [] |
NCT04126031 | 6.3 | Subject Withdrawal [Early Termination] | 6.3. Subject Withdrawal [Early Termination]
Withdrawal of Consent: Subjects whose parent(s)/legal guardian/legally acceptable representative request to discontinue receipt of study treatment will remain in the study and must continue to be followed for protocol specified follow-up procedures. The only exception to thi... | [
"Withdrawal of Consent:",
"Lost to Follow-Up:"
] |
NCT04126031 | 7 | ASSESSMENTS | 7. ASSESSMENTS Every effort should be made to ensure that the protocol-required tests and procedures are completed as described. However, it is anticipated that from time to time there may be circumstances outside of the control of the Investigator that may make it unfeasible to perform the test. In these cases the Inv... | [] |
NCT04126031 | 7.1 | Pharmacokinetics | 7.1. Pharmacokinetics | [] |
NCT04126031 | 7.1.1 | Plasma for Analysis of Ceftazidime - Avibactam | 7.1.1. Plasma for Analysis of Ceftazidime - Avibactam Blood samples (0.3 mL) to provide approximately 0.15 mL of plasma for pharmacokinetic (PK) analysis will be collected into appropriately labeled tubes containing Sodium Fluoride/Potassium Oxalate (custom blue top) at times as shown in [Figure 3](#page-53-0) and spec... | [] |
NCT04126031 | 7.2 | Banked Biospecimens | 7.2. Banked Biospecimens Not applicable. | [] |
NCT04126031 | 7.2.1 | Additional Research | 7.2.1. Additional Research Not applicable. | [] |
NCT04126031 | 7.3 | Microbiology | 7.3. Microbiology | [] |
NCT04126031 | 7.3.1 | Blood Sample for Culture | 7.3.1. Blood Sample for Culture If clinically indicated and performed as part of subject's regular medical care, obtain blood for culture at Baseline (preferably before any antibacterials are administered) and at any time through TOC. Cultures should be repeated per standard of care upon knowledge of a positive result ... | [] |
NCT04126031 | 7.3.2 | Urine Sample for Culture | 7.3.2. Urine Sample for Culture If clinically indicated per standard of care, obtain urine for culture at Baseline (preferably before any antibacterials are administered) and at any time through TOC. Cultures should be repeated per standard of care upon knowledge of a positive result until sterilization is confirmed. P... | [] |
NCT04126031 | 7.3.3 | Other Specimens and Tissue Samples for Culture | 7.3.3. Other Specimens and Tissue Samples for Culture If clinically indicated and performed as part of subject's regular medical care, obtain other specimen and tissue samples from potential foci of infection for culture as clinically indicated at Baseline (preferably before any antibiotics are administered) and at any... | [] |
NCT04126031 | 7.4 | Safety Assessments | 7.4. Safety Assessments Subjects must be evaluated by a physician or an appropriately trained health care professional at every visit, and the evaluation must be documented. The procedures discussed below will be completed at the designated visits. | [] |
NCT04126031 | 7.4.1 | Laboratory Safety Assessments | 7.4.1. Laboratory Safety Assessments Blood samples and urine samples will be collected at screening baseline and EOIV, if applicable. Samples may also be collected at any time during the treatment period, at TOC and LFU if clinically indicated. The following laboratory variables will be measured: Table 3. Laboratory Sa... | [] |
NCT04126031 | 7.5 | Blood Volume | 7.5. Blood Volume This protocol complies with European Union's recommendations for blood loss associated with pediatric research (Anonymous, 2017)[7](#page-80-0) and the World Health Organization guidelines "Blood Sample Volumes in Child Health Research: Review of Safe Limits" (Howie, 2011). [8](#page-80-1) To minimize... | [] |
NCT04126031 | 8 | ADVERSE EVENT REPORTING | 8. ADVERSE EVENT REPORTING | [] |
NCT04126031 | 8.1 | Requirements | 8.1. Requirements The table below summarizes the requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial (CT) Serious Adverse Event (SAE) Report Form to Pfizer Safety. These requirements are delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs... | [] |
NCT04126031 | 8.1.1 | Additional Details on Recording Adverse Events on the CRF | 8.1.1. Additional Details on Recording Adverse Events on the CRF All events detailed in the table above will be recorded on the AE page(s) of the CRF. It should be noted that the CT SAE Report Form for reporting of SAE information is not the same as the AE page of the CRF. When the same data are collected, the forms mu... | [] |
NCT04126031 | 8.1.2 | Eliciting Adverse Event Information | 8.1.2. Eliciting Adverse Event Information The Investigator is to record on the CRF all directly observed AEs and all AEs spontaneously reported by the study subject's parent(s)/legal guardian/legally acceptable representative. In addition, each study subject's parent(s)/legal guardian/legally acceptable representative... | [] |
NCT04126031 | 8.1.3 | Withdrawal From the Study Due to Adverse Events (see also the [Subject](#page-51-0) [Withdrawal \[Early Termination\]](#page-51-0) section) | 8.1.3. Withdrawal From the Study Due to Adverse Events (see also the [Subject](#page-51-0) [Withdrawal \[Early Termination\]](#page-51-0) section) Withdrawal due to AEs should be distinguished from withdrawal due to other causes, according to the definition of AE noted below, and recorded on the CRF. When a subject wit... | [] |
NCT04126031 | 8.1.4 | Time Period for Collecting AE/SAE Information | 8.1.4. Time Period for Collecting AE/SAE Information The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each subject begins from the time the subject's parent(s)/legal guardian/legally acceptable representative provides informed consent, which is obtained before the subj... | [] |
NCT04126031 | 8.1.4.1 | Reporting SAEs to Pfizer Safety | 8.1.4.1. Reporting SAEs to Pfizer Safety All SAEs occurring in a subject during the active collection period are reported to Pfizer Safety on the CT SAE Report Form. SAEs occurring in a subject after the active collection period has ended are reported to Pfizer Safety if the Investigator becomes aware of them; at a min... | [] |
NCT04126031 | 8.1.4.2 | Recording Non-serious AEs and SAEs on the CRF | 8.1.4.2. Recording Non-serious AEs and SAEs on the CRF During the active collection period, both non-serious AEs and SAEs are recorded on the CRF. Follow-up by the Investigator may be required until the event or its sequelae resolve or stabilize at a level acceptable to the Investigator, and Pfizer concurs with that as... | [] |
NCT04126031 | 8.1.5 | Causality Assessment | 8.1.5. Causality Assessment The Investigator's assessment of causality must be provided for all AEs (serious and non-serious); the Investigator must record the causal relationship on the CRF, and report such an assessment in accordance with the SAE reporting requirements, if applicable. An Investigator's causality asse... | [] |
NCT04126031 | 8.1.6 | Sponsor's Reporting Requirements to Regulatory Authorities | 8.1.6. Sponsor's Reporting Requirements to Regulatory Authorities AE reporting, including suspected unexpected serious adverse reactions, will be carried out in accordance with applicable local regulations. | [] |
NCT04126031 | 8.2 | Definitions | 8.2. Definitions | [] |
NCT04126031 | 8.2.1 | Adverse Events | 8.2.1. Adverse Events An AE is any untoward medical occurrence in a study subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Examples of AEs include, but are not limited to: - Abnormal test findings; - Clinically significant signs and... | [] |
NCT04126031 | 8.2.2 | Abnormal Test Findings | 8.2.2. Abnormal Test Findings Abnormal objective test findings should be recorded as AEs when any of the following conditions are met: - Test result is associated with accompanying symptoms; and/or - Test result requires additional diagnostic testing or medical/surgical intervention; and/or - Test result leads to a cha... | [] |
NCT04126031 | 8.2.3 | Serious Adverse Events | 8.2.3. Serious Adverse Events A serious adverse event is any untoward medical occurrence at any dose that: - Results in death; - Is life-threatening (immediate risk of death); - Requires inpatient hospitalization or prolongation of existing hospitalization; - Results in persistent or significant disability/incapacity (... | [] |
NCT04126031 | 8.2.4 | Hospitalization | 8.2.4. Hospitalization Hospitalization is defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility, or any prolongation of an existing admission. Admission also includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric wing to a med... | [] |
NCT04126031 | 8.3 | Severity Assessment | 8.3. Severity Assessment | If required on the AE page of the CRF, the Investigator will use the adjectives MILD,MODERATE, or SEVERE to describe the maximum intensity of the AE. For purposes ofconsistency, these intensity grades are defined as follows: | | | | | |---------------------------------------------------------... | [] |
NCT04126031 | 8.4 | Special Situations | 8.4. Special Situations | [] |
NCT04126031 | 8.4.1 | Protocol-Specified Serious Adverse Events | 8.4.1. Protocol-Specified Serious Adverse Events There are no protocol specified SAEs in this study. All SAEs will be reported to Pfizer Safety by the Investigator as described in previous sections, and will be handled as SAEs in the safety database. | [] |
NCT04126031 | 8.4.2 | Potential Cases of Drug-Induced Liver Injury | 8.4.2. Potential Cases of Drug-Induced Liver Injury Humans exposed to a drug who show no sign of liver injury (as determined by elevations in transaminases) are termed "tolerators," while those who show transient liver injury, but adapt are termed "adaptors." In some subjects, transaminase elevations are a harbinger of... | [] |
NCT04126031 | 8.4.3 | Exposure to the Investigational Product During Pregnancy or Breastfeeding, and Occupational Exposure | 8.4.3. Exposure to the Investigational Product During Pregnancy or Breastfeeding, and Occupational Exposure Exposure to the investigational product under study during pregnancy or breastfeeding and occupational exposure are reportable to Pfizer Safety within 24 hours of Investigator awareness. | [] |
NCT04126031 | 8.4.3.1 | Exposure During Pregnancy | 8.4.3.1. Exposure During Pregnancy Not applicable. | [] |
NCT04126031 | 8.4.3.2 | Exposure During Breastfeeding | 8.4.3.2. Exposure During Breastfeeding Not applicable. | [] |
NCT04126031 | 8.4.3.3 | Occupational Exposure | 8.4.3.3. Occupational Exposure An occupational exposure occurs when, during the performance of job duties, a person (whether a healthcare professional or otherwise) gets in unplanned direct contact with the product, which may or may not lead to the occurrence of an AE. An occupational exposure is reported to Pfizer Saf... | [] |
NCT04126031 | 8.4.4 | Medication Errors and Lack of Efficacy | 8.4.4. Medication Errors and Lack of Efficacy Other exposures to the investigational product under study may occur in clinical trial settings, such as medication errors and lack of efficacy. | Safety Event | Recorded on the CRF | Reported on the CT SAEReport Form to PfizerSafety Within 24 Hours of | |------------------... | [] |
NCT04126031 | 8.4.4.1 | Medication Errors | 8.4.4.1. Medication Errors Medication errors may result from the administration or consumption of the investigational product by the wrong subject, or at the wrong time, or at the wrong dosage strength. Medication errors include: - Medication errors involving subject exposure to the investigational product; - Potential... | [] |
NCT04126031 | 8.4.4.2 | Lack of Efficacy | 8.4.4.2. Lack of Efficacy Lack of efficacy is reportable to Pfizer Safety only if associated with an SAE. | [] |
NCT04126031 | 9 | DATA ANALYSIS/STATISTICAL METHODS | 9. DATA ANALYSIS/STATISTICAL METHODS Detailed methodology for summary and statistical analyses of the data collected in this study is outlined here and further detailed in a statistical analysis plan (SAP), which will be maintained by the Sponsor and finalized before database lock. The SAP may modify what is outlined i... | [] |
NCT04126031 | 9.1 | Sample Size Determination | 9.1. Sample Size Determination The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of CAZ-AVI in neonates and young infants with bacterial infections. Limited efficacy information will be available as a secondary objective of Part B. The study is not powered for inferential... | [] |
NCT04126031 | 9.2 | Pharmacokinetic Analysis (Primary Objective Part A, Secondary Objective Part B) | 9.2. Pharmacokinetic Analysis (Primary Objective Part A, Secondary Objective Part B) The PK analysis set will consist of all subjects who received a single IV dose of CAZ-AVI in Part A or at least 3 consecutive doses of CAZ-AVI in Part B with at least 1 ceftazidime and/or avibactam plasma PK measurement available. A li... | [] |
NCT04126031 | 9.3 | Safety Analysis (Primary Objective Part B, Secondary Objective Part A) | 9.3. Safety Analysis (Primary Objective Part B, Secondary Objective Part A) The safety analysis set will consist of all subjects who received any amount of IV study dose of CAZ-AVI. Parts A and B will be summarized separately in addition to an overall safety summary. No inferential statistical tests will be performed f... | [] |
NCT04126031 | 9.4 | Efficacy Analysis (Secondary Objective Part B) | 9.4. Efficacy Analysis (Secondary Objective Part B) The Intent-to-Treat (ITT) analysis set is defined as all subjects who have been enrolled in each part of the study, regardless of whether or not treatment was received. All cause mortality will be summarized with counts and proportions of deaths and 95% confidence int... | [] |
NCT04126031 | 9.4.1 | Efficacy Response Definitions | 9.4.1. Efficacy Response Definitions Table 5. Definition of Clinical Response Categories at the EOIV, EOT, TOC and LFU | ClinicalResponse | Definition | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04126031 | 9.4.2 | Microbiological Response Definitions | 9.4.2. Microbiological Response Definitions The per-pathogen microbiological outcome categories at TOC are defined in Table 6. Favorable microbiological outcomes are eradication or presumed eradication. Baseline pathogens will be determined based on central laboratory data. In the absence of any baseline central labora... | [] |
NCT04126031 | 9.5 | Interim Analysis | 9.5. Interim Analysis An interim report summarizing the existing data may be prepared for the purpose of Regulatory submission after the completion of Part A and completion of at least 4 subjects in each cohort of Part B. Detailed methodology for the interim report will be included in the SAP. As this is an open-label ... | [] |
NCT04126031 | 9.6 | Data Monitoring Committee | 9.6. Data Monitoring Committee This study will use an external data monitoring committee (E-DMC). The E-DMC will be responsible for ongoing monitoring of the safety of subjects in the study according to the charter. The recommendations made by the E-DMC to alter the conduct of the study will be forwarded to Pfizer for ... | [] |
NCT04126031 | 9.7 | Safety Review Committee | 9.7. Safety Review Committee A Safety Review Committee (SRC) consisting of the study team physician, international coordinating Investigator or delegate, global safety/risk lead or delegate, therapeutic area director or delegate and the clinical pharmacologist/pharmacometrician or delegate will assess PK, safety and to... | [] |
NCT04126031 | 10 | QUALITY CONTROL AND QUALITY ASSURANCE | 10. QUALITY CONTROL AND QUALITY ASSURANCE Pfizer or its agent will conduct periodic monitoring visits during study conduct to ensure that the protocol and Good Clinical Practices (GCPs) are being followed. The monitors may review source documents to confirm that the data recorded on CRFs are accurate. The Investigator ... | [] |
NCT04126031 | 11 | DATA HANDLING AND RECORD KEEPING | 11. DATA HANDLING AND RECORD KEEPING | [] |
NCT04126031 | 11.1 | Case Report Forms/Electronic Data Record | 11.1. Case Report Forms/Electronic Data Record As used in this protocol, the term CRF should be understood to refer to either a paper form or an electronic data record or both, depending on the data collection method used in this study. A CRF is required and should be completed for each included subject. The completed ... | [] |
NCT04126031 | 11.2 | Record Retention | 11.2. Record Retention To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the Investigator agrees to keep records, including the identity of all participating subjects (sufficient information to link records, eg, CRFs and hospital records), all original signed informed consent docume... | [] |
NCT04126031 | 12 | ETHICS | 12. ETHICS | [] |
NCT04126031 | 12.1 | Institutional Review Board/Ethics Committee | 12.1. Institutional Review Board/Ethics Committee It is the responsibility of the Investigator to have prospective approval of the study protocol, protocol amendments, informed consent documents, and other relevant documents, eg, recruitment advertisements, if applicable, from the IRB/EC. All correspondence with the IR... | [] |
NCT04126031 | 12.2 | Ethical Conduct of the Study | 12.2. Ethical Conduct of the Study The study will be conducted in accordance with the protocol, legal and regulatory requirements, and the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 20... | [] |
NCT04126031 | 12.3 | Subject Information and Consent | 12.3. Subject Information and Consent All parties will comply with all applicable laws, including laws regarding the implementation of organizational and technical measures to ensure protection of subject personal data. Such measures will include omitting subject names or other directly identifiable data in any reports... | [] |
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