protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03667690 | 4.11 | Rationale for Use of Rezafungin for Injection in Candidemia and Invasive Candidiasis | 4.11 Rationale for Use of Rezafungin for Injection in Candidemia and Invasive Candidiasis Candidemia is a fungal bloodstream infection usually affecting patients who are already ill with other comorbidities. Invasive candidiasis defines a number of different organ-specific infections with Candida spp. Candidemia and in... | [
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection"
] |
NCT03667690 | 4.12 | Statement of Compliance | 4.12 Statement of Compliance This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), the ethical principles of the Declaration of Helsinki, and applicable regulatory and Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements. Protocol Amendment 5 Confiden... | [] |
NCT03667690 | 5.0 | STUDY OBJECTIVES | 5.0 STUDY OBJECTIVES The primary objectives of this study are to: - Demonstrate that Rezafungin for Injection is non-inferior to caspofungin for all-cause mortality (ACM) at Day 30 (-2 days) in the modified intent-to-treat (mITT) population (US Food and Drug Administration [FDA] primary objective) - Demonstrate that Re... | [] |
NCT03667690 | 6.0 | STUDY DESIGN | 6.0 STUDY DESIGN | [] |
NCT03667690 | 6.1 | Description of the Study | 6.1 Description of the Study The study design figure is provided in [Figure 1.](#page-14-0) The Schedule of Assessments and Procedures for the Required Treatment, EOT, and Follow-up Periods is presented in [Table 1](#page-17-0) and the Schedule of Assessments and Procedures for the Optional Treatment Period is presente... | [] |
NCT03667690 | 6.1.1 | Subjects Randomized to Rezafungin for Injection | 6.1.1 Subjects Randomized to Rezafungin for Injection Subjects randomized to Rezafungin for Injection will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. To maintain the blind, subjects will also receive daily placebo to match for caspofungin IV, which will be admi... | [] |
NCT03667690 | 6.1.2 | Subjects Randomized to Caspofungin | 6.1.2 Subjects Randomized to Caspofungin Subjects randomized to caspofungin will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1, followed by caspofungin 50 mg IV once daily with the option to continue treatment ≤28 days. After ≥3 days (or the minimum duration of... | [] |
NCT03667690 | 6.1.3 | End of Treatment Visit and Follow-up Visits | 6.1.3 End of Treatment Visit and Follow-up Visits Subjects will complete an EOT visit within 2 calendar days after the last dose of study drug, and a Follow-up visit within the Day 52–59 period. Subjects who stop study drug prior to Day 22 AND are considered clinical failures (i.e., require a change in antifungal thera... | [] |
NCT03667690 | 6.1.4 | Mycological Diagnosis | 6.1.4 Mycological Diagnosis Mycological diagnosis of candidemia and/or invasive candidiasis sufficient for inclusion in the study will be established by one of the following test results from a blood sample or normally sterile site collected ≤4 days (96 hours) before randomization: - ≥1 blood culture positive for yeast... | [] |
NCT03667690 | 6.1.5 | Retinal Examination | 6.1.5 Retinal Examination A retinal examination for evidence of a Candida eye infection, including endophthalmitis or chorioretinitis, should be performed on all subjects with candidemia during Screening when possible, although the exam may occur as late as Day 7. Retinal examination is standard of care for subjects wi... | [] |
NCT03667690 | 6.1.6 | Study Day Definition | 6.1.6 Study Day Definition Study Day 1 is defined as the first day of study drug administration. Subsequent study days are counted as the number of consecutive calendar days thereafter. | [] |
NCT03667690 | 6.1.7 | Efficacy Assessments | 6.1.7 Efficacy Assessments Efficacy assessments for all subjects occur on Day 5, Day 14 (±1 day), Day 30 (-2 days), EOT (≤2 days of last dose), and the Follow-up visit (Days 52–59). Clinical cure, radiological cure (for qualifying invasive candidiasis subjects), and mycological eradication will be assessed on all effic... | [
"a. Subjects with ≥1 blood culture positive for yeast or Candida",
"b. Subjects with a positive culture for Candida spp. from a normally sterile site"
] |
NCT03667690 | 6.1.8 | Safety Assessments | 6.1.8 Safety Assessments Safety monitoring data is collected throughout the study. Adverse events are collected from the time the informed consent document is signed through the Follow-up visit (Days 52–59). Vital signs will be measured at each study visit. A physical examination will be performed at the Screening, Day... | [] |
NCT03667690 | 6.1.9 | PK Sampling | 6.1.9 PK Sampling Blood samples for PK analysis must be collected from the OPPOSITE arm of the infusion or through an arterial line during the infusion; after the infusion is complete, opposite arm or arterial line draws are preferred, but not mandatory. Blood samples will be collected as follows: - Day 1: within 10 mi... | [] |
NCT03667690 | 6.2 | Number of Subjects | 6.2 Number of Subjects Approximately 218 subjects will be randomized to treatment (1:1, Rezafungin for Injection to caspofungin). The target of 218 subjects assumes approximately 85% of randomized subjects will be evaluable for the mITT population. Thus, 184 subjects will be in the mITT population (92 subjects in each ... | [] |
NCT03667690 | 6.3 | Measures Taken to Minimize Bias | 6.3 Measures Taken to Minimize Bias Treatment assignment will be blinded to all blinded clinical site and sponsor personnel (double-blind) until the study database is locked. Unblinded personnel includes the site pharmacist preparing the infusions and the unblinded monitor to ensure study drug accountability and assign... | [] |
NCT03667690 | 6.4 | Expected Duration of Subject Participation | 6.4 Expected Duration of Subject Participation Maximum study duration for an individual subject is 63 days, including Screening (≤4 days, 96 hours), the Required Treatment Period (Day 1 to Day 14 [14 days]), the Optional Extended Treatment Period (Day 15 to Day 28), and Follow-up (Days 52–59). | [] |
NCT03667690 | 6.5 | Method of Treatment Assignment and Blinding | 6.5 Method of Treatment Assignment and Blinding After informed consent has been obtained, subjects will be screened for study eligibility before randomization. Subjects will be randomly assigned (1:1 ratio) to receive either Rezafungin for Injection or caspofungin. Randomization will be stratified based on diagnosis (c... | [
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection"
] |
NCT03667690 | 7.0 | SELECTION, DISCONTINUATION, AND WITHDRAWAL OF SUBJECTS | 7.0 SELECTION, DISCONTINUATION, AND WITHDRAWAL OF SUBJECTS | [] |
NCT03667690 | 7.1 | Subject Inclusion Criteria | 7.1 Subject Inclusion Criteria Subjects must meet ALL the following inclusion criteria to qualify for the study: - 1. Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative (i.e., acceptable to International Council on Harmonisa... | [] |
NCT03667690 | 7.1.1 | Rapid In Vitro Diagnostics for Candidemia and Invasive Candidiasis | 7.1.1 Rapid In Vitro Diagnostics for Candidemia and Invasive Candidiasis The addition of rapid IVD for the identification of subjects with candidemia and/or invasive candidiasis is being employed to reduce the amount of prior empiric antifungal therapy being administered to potential study subjects. Rapid IVDs for Cand... | [] |
NCT03667690 | 7.1.2 | Systemic Signs of Candidemia and Invasive Candidiasis | 7.1.2 Systemic Signs of Candidemia and Invasive Candidiasis It is a requirement that at least 1 systemic sign attributable to candidemia and/or invasive candidiasis be present at Screening for the subject to be eligible for enrollment. The Screening period for assessing systemic signs for inclusion in the study may inc... | [] |
NCT03667690 | 7.2 | Subject Exclusion Criteria | 7.2 Subject Exclusion Criteria Subjects must NOT meet any of the following exclusion criteria to qualify for the study: - 1. Any of the following forms of invasive candidiasis at baseline: - a. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed) - b. Osteomyelitis - c. Endocarditis or... | [] |
NCT03667690 | 7.3 | Requalification for Entry | 7.3 Requalification for Entry Subjects not fulfilling the entry criteria and not randomized may be rescreened for participation if their eligibility characteristics have changed. | [] |
NCT03667690 | 7.4 | Subject Withdrawal Criteria | 7.4 Subject Withdrawal Criteria | [] |
NCT03667690 | 7.4.1 | Withdrawal from Study Protocol | 7.4.1 Withdrawal from Study Protocol Subjects may withdraw consent to participate in this study at any time without penalty or loss of benefits to which the subject is otherwise entitled. Subjects on study drug who wish to withdraw completely from this clinical study should be encouraged to complete the assessments at ... | [] |
NCT03667690 | 7.4.2 | Early Discontinuation from Study Drug Administration | 7.4.2 Early Discontinuation from Study Drug Administration For subjects who prematurely discontinue study drug (i.e., before the anticipated full course of study drug therapy required for effective treatment of candidemia and/or invasive candidiasis), EOT assessments should be performed on the day of discontinuation. F... | [
"• Safety",
"• Insufficient therapeutic effect",
"• Investigator discretion"
] |
NCT03667690 | 7.5 | Replacement of Subjects | 7.5 Replacement of Subjects Randomized subjects who are withdrawn will not be replaced. | [] |
NCT03667690 | 7.6 | Study Termination by Sponsor and Termination Criteria | 7.6 Study Termination by Sponsor and Termination Criteria The Sponsor reserves the right to terminate an investigational site or this clinical study at any time. Reasons for termination may include, but are not limited to, the following: - The incidence or severity of AEs in this or other studies of Rezafungin for Inje... | [] |
NCT03667690 | 8.0 | STUDY DRUGS | 8.0 STUDY DRUGS Subjects will be randomized in a 1:1 ratio to receive Rezafungin for Injection IV or Caspofungin IV. Oral step-down therapy is allowed in both treatment groups; oral placebo in the Rezafungin for Injection group and oral fluconazole in the Caspofungin group. The total IV plus oral treatment duration wil... | [] |
NCT03667690 | 8.1 | Rezafungin for Injection | 8.1 Rezafungin for Injection | [] |
NCT03667690 | 8.1.1 | Formulation | 8.1.1 Formulation Rezafungin for Injection is a lyophilized formulation of the active pharmaceutical ingredient, rezafungin acetate. Rezafungin for Injection is supplied in vials as a sterile lyophilized powder (200 mg) for reconstitution prior to dilution into normal saline infusion bags (250 mL). Excipients for rezaf... | [] |
NCT03667690 | 8.1.2 | Directions for Use | 8.1.2 Directions for Use Rezafungin for Injection is administered IV with a 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Intravenous infusion of Rezafungin for Injection and IV placebo is administered over 60 (±10) minutes, although the infusion time may be increa... | [] |
NCT03667690 | 8.1.3 | Drug Storage | 8.1.3 Drug Storage Vials of Rezafungin for Injection and infusion bags with diluted Rezafungin for Injection should be stored per the directions presented in the study Pharmacy Manual. | [] |
NCT03667690 | 8.1.4 | Dose Adjustment | 8.1.4 Dose Adjustment Dosage adjustments are not allowed in this study. | [] |
NCT03667690 | 8.2 | Placebo and Comparator Treatment | 8.2 Placebo and Comparator Treatment | [] |
NCT03667690 | 8.2.1 | Placebo | 8.2.1 Placebo In this double-blind, double-dummy, active comparator study, two placebo regimens are required; one for subjects randomized to Rezafungin for Injection and one for subjects randomized to caspofungin. In addition, because subjects in the caspofungin arm may be switched to oral step-down therapy, an oral pl... | [
"Placebo Regimen for Rezafungin for Injection Treatment Assignment",
"Placebo Regimen for Caspofungin IV Treatment Assignment"
] |
NCT03667690 | 8.2.2 | Caspofungin | 8.2.2 Caspofungin Anaphylaxis has been reported with administration of caspofungin. If this occurs, caspofungin should be discontinued immediately and appropriate treatment administered. Possible histamine-like reactions, including rash, facial swelling, sensation of warmth, pruritis, and bronchospasm, have been observ... | [] |
NCT03667690 | 8.2.2.1 | Formulation | 8.2.2.1 Formulation Caspofungin IV is provided in its commercial formulation. Excipients for caspofungin include sucrose, mannitol, glacial acetic acid, and sodium hydroxide (refer to the US Prescribing Information or SmPC for excipients used in specific generic versions). | [] |
NCT03667690 | 8.2.2.2 | Directions for Use | 8.2.2.2 Directions for Use The manufacturer's instructions for caspofungin dose preparation should be followed. Subjects randomized to caspofungin will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg once daily with the option to continue treatm... | [] |
NCT03667690 | 8.2.2.3 | Drug Storage | 8.2.2.3 Drug Storage The manufacturer's instructions for caspofungin storage should be followed. Protocol Amendment 5 Confidential Page 71 of 156 | [] |
NCT03667690 | 8.2.2.4 | Dose Adjustment | 8.2.2.4 Dose Adjustment Subjects with moderate hepatic impairment (Child-Pugh score of 7–9): loading dose of caspofungin of 70 mg on Day 1 followed by 35 mg once daily. Subjects weighing >80 kg or on concomitant rifampin, nevirapine, efavirenz, phenytoin, dexamethasone, or carbamazepine: caspofungin 70 mg once daily. D... | [] |
NCT03667690 | 8.2.3 | Oral Step-Down Therapy: Fluconazole | 8.2.3 Oral Step-Down Therapy: Fluconazole Fluconazole should not be co-administered with terfenadine, cisapride, astemizole, erythromycin, pimozide, quinidine, halofantrine, or any other drug metabolized via the CYP3A4 enzymatic pathway and may cause prolongation of the QT interval. Fluconazole is a potent CYP2C9 inhib... | [] |
NCT03667690 | 8.2.3.1 | Formulation | 8.2.3.1 Formulation Commercial fluconazole tablets have been over-encapsulated for study blinding. Excipients for fluconazole include microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red Dye No. 40 aluminum lake dye, and magnesium stearate. | [] |
NCT03667690 | 8.2.3.2 | Directions for Use | 8.2.3.2 Directions for Use After ≥3 days of caspofungin treatment (or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects who meet the step-down therapy eligibility criteria may be switched to oral fluconazole (earliest oral dose on Day 4 or later... | [] |
NCT03667690 | 8.2.3.3 | Oral Step-Down Therapy Eligibility Criteria | 8.2.3.3 Oral Step-Down Therapy Eligibility Criteria An oral step-down therapy is allowed in both treatment groups (fluconazole for caspofungin, placebo for oral step-down therapy for Rezafungin for Injection), provided the following criteria are met: - Able to take oral medication - ≥3 days of IV study drug (or the min... | [] |
NCT03667690 | 8.2.3.4 | Drug Storage | 8.2.3.4 Drug Storage Capsule containing fluconazole tablets (over-encapsulated fluconazole) should be stored per the directions presented in the study Pharmacy Manual. | [] |
NCT03667690 | 8.2.3.5 | Dose Adjustment for Renal Impairment | 8.2.3.5 Dose Adjustment for Renal Impairment Subjects with creatinine clearance ≤50 mL/min (see [Appendix 2\)](#page-142-0) will receive oral fluconazole at a dose of 3 mg/kg administered once daily rounded to the nearest 200 mg increment with a maximum daily dose of 400 mg. Subjects receiving hemodialysis receive the ... | [] |
NCT03667690 | 8.3 | Compliance | 8.3 Compliance Treatment compliance for IV study drugs will be documented in the eCRF by recording the date, start time, stop time, and whether the dose of study drug was completely infused. For oral fluconazole (caspofungin group) or placebo for oral step-down therapy (Rezafungin for Injection groups), treatment compl... | [] |
NCT03667690 | 8.4 | Breaking the Blind | 8.4 Breaking the Blind The study is a double-blind design. The Sponsor, PI, study site personnel, and subjects will not make any effort to determine which blinded study drug therapy (Rezafungin for Injection or caspofungin with the option of step-down therapy) is being administered or received. Protocol Amendment 5 Con... | [
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection"
] |
NCT03667690 | 8.5 | Prior and Concomitant Medications and Substances | 8.5 Prior and Concomitant Medications and Substances All systemic antifungal therapy administered within 4 weeks and all non-antifungal therapy administered within 1 week prior to randomization will be documented and recorded in the eCRF. Subjects who received systemic treatment with an antifungal agent at approved dos... | [] |
NCT03667690 | 8.6 | Accountability Procedures | 8.6 Accountability Procedures The pharmacy or other unblinded study personnel are responsible for ensuring that a current record of Rezafungin for Injection, caspofungin, fluconazole, and placebo inventory and accountability is maintained. A Pharmacy Monitor will be responsible for checking study drug accountability at... | [] |
NCT03667690 | 8.7 | Study Drug Handling and Disposal | 8.7 Study Drug Handling and Disposal Unless expressly disallowed by institution rules, used and unused vials of study drug (including Rezafungin for Injection and caspofungin) will be retained at the study site until study drug accountability has been performed by the Pharmacy Monitor. Upon completion of the study, Pro... | [] |
NCT03667690 | 9.0 | STUDY PROCEDURES | 9.0 STUDY PROCEDURES Screening procedures are summarized in [Section 9.1,](#page-78-1) the Required Treatment Period procedures and Follow-up procedures are summarized in [Section 9.2](#page-80-0) and [Section](#page-95-0) 9.3, respectively, and the Optional Treatment Period (Days 15–28) procedures are summarized in [S... | [] |
NCT03667690 | 9.1 | Screening (≤4 days [96 hours]) | 9.1 Screening (≤4 days [96 hours]) - Obtain written informed consent prior to initiating any study related assessments or procedures. Consent from a legally acceptable representative (i.e. acceptable to ICH and local law, as applicable) may be obtained if the subject is unable to consent for themselves. - Obtain a comp... | [
"• Laboratory assessments:"
] |
NCT03667690 | 9.2 | Required Treatment Period | 9.2 Required Treatment Period | [] |
NCT03667690 | 9.2.1 | Day 1 | 9.2.1 Day 1 - Randomize subject just prior to dosing. - Administer IV infusion of study drug over 60 (±10) minutes (refer to [Section 8.0](#page-68-0) and Study Pharmacy Manual for additional infusion rate guidance). - Clinical Assessments: Protocol Amendment 5 Confidential Page 80 of 156 - o A focused physical exam (i... | [
"• Laboratory Assessments:"
] |
NCT03667690 | 9.2.2 | Day 2 | 9.2.2 Day 2 - Administer IV infusion of study drug over 60 (±10) minutes (refer to [Section 8.0](#page-68-0) and Study Pharmacy Manual for additional infusion rate guidance). - Clinical Assessments: - o A focused physical exam (including a neurological exam) should be performed as clinically indicated by AE screening a... | [
"• Laboratory Assessments:"
] |
NCT03667690 | 9.2.3 | Day 3 | 9.2.3 Day 3 - Administer IV infusion of study drug over 60 (±10) minutes (refer to [Section 8.0](#page-68-0) and Study Pharmacy Manual for additional infusion rate guidance). - Clinical Assessments: - o A focused physical exam (including a neurological exam) should be performed as clinically indicated by AE screening a... | [
"• Laboratory Assessments:"
] |
NCT03667690 | 9.2.4 | Day 4 | 9.2.4 Day 4 - Administer study drug: - o IV infusion of study drug over 60 (±10) minutes (refer to [Section 8.0](#page-68-0) and the Study Pharmacy Manual for additional infusion rate guidance). Administration should occur 24 (±2) hours after study drug was administered on the previous day. OR o Oral step-down therapy.... | [
"• Clinical Assessments:",
"• Laboratory Assessments:"
] |
NCT03667690 | 9.2.5 | Days 5–7 | 9.2.5 Days 5–7 - Administer study drug - o IV infusion of study drug over 60 (±10) minutes (refer to Sect[ion 8.0](#page-68-0) and the Study Pharmacy Manual for additional infusion rate guidance). Administration should occur 24 (±2) hours after study drug was administered on the previous day. OR - o Oral step-down ther... | [] |
NCT03667690 | 9.2.6 | Day 8 (±1 day) | 9.2.6 Day 8 (±1 day) - One blood sample for PK will be collected predose (≤30 minutes prior to the start of the infusion). Draw blood for PK analysis from the OPPOSITE arm or through an arterial line during the infusion; after the infusion is complete, opposite arm or arterial line draws are preferred. For subjects rec... | [
"• Clinical Assessments:",
"• Laboratory Assessments:"
] |
NCT03667690 | 9.2.7 | Days 9–13 | 9.2.7 Days 9–13 - Administer study drug: - o IV infusion of study drug over 60 (±10) minutes (refer to [Section 8.0](#page-68-0) and the Study Pharmacy Manual for additional infusion rate guidance). Administration should occur 24 (±2) hours after study drug was administered on the previous day. OR - o Oral step-down th... | [] |
NCT03667690 | 9.2.8 | Day 14 (±1 day) | 9.2.8 Day 14 (±1 day) - Administer study drug: - o IV infusion of study drug over 60 (±10) minutes (refer to [Section 8.0](#page-68-0) and the Study Pharmacy Manual for additional infusion rate guidance). Administration should occur 24 (±2) hours after study drug was administered on the previous day. OR - o Oral step-d... | [
"Laboratory assessments:"
] |
NCT03667690 | 9.2.9 | Day 30 (-2 days) | 9.2.9 Day 30 (-2 days) - Clinical Assessments: - o Conduct complete physical examination. - o Conduct neurological examination as part of the physical examination, as clinically indicated. - o Measure vital signs (temperature and the method used [oral, rectal, temporal, tympanic, or core], heart rate, blood pressure, a... | [] |
NCT03667690 | 9.2.10 | End of Treatment (≤2 days of last dose) | 9.2.10 End of Treatment (≤2 days of last dose) - Clinical Assessments: - o Assess for clinical response [\(Table 9\)](#page-106-3). - o Conduct complete physical examination. - o Conduct a thorough neurological examination as part of the physical examination. - o Measure vital signs (temperature and the method used [or... | [] |
NCT03667690 | 9.3 | Follow-up (Days 52–59) | 9.3 Follow-up (Days 52–59) - Clinical Assessments: - o Conduct complete physical examination, including weight. Protocol Amendment 5 Confidential Page 95 of 156 - o Conduct neurological examination as part of the physical examination, as clinically indicated. - o Measure vital signs (temperature and the method used [or... | [] |
NCT03667690 | 9.4 | Optional Treatment Period | 9.4 Optional Treatment Period | [] |
NCT03667690 | 9.4.1 | Days 15 (±1 day) | 9.4.1 Days 15 (±1 day) • One blood sample for PK will be collected pre-dose (≤30 minutes prior to the start of the infusion). Draw blood for PK analysis from the OPPOSITE arm or through an arterial line during the infusion; after the infusion is complete, opposite arm or arterial line draws are preferred. For subjects ... | [
"• Administer study drug:",
"• Clinical Assessments:",
"• Laboratory Assessments:"
] |
NCT03667690 | 9.4.2 | Days 16–21 | 9.4.2 Days 16–21 - Administer study drug: - o IV infusion of study drug over 60 (±10) minutes (refer to [Section 8.0](#page-68-0) and the Study Pharmacy Manual for additional infusion rate guidance); administration should occur 24 (±2) hours after study drug was administered on the previous day. OR - o Oral step-down t... | [
"• Laboratory Assessments:"
] |
NCT03667690 | 9.4.3 | Day 22 (±1 day) | 9.4.3 Day 22 (±1 day) • One blood sample for PK will be collected pre-dose (≤30 minutes prior to the start of the infusion). Draw blood for PK analysis from the OPPOSITE arm or through an arterial line during the infusion; after the infusion is complete opposite arm or arterial line draws are preferred. For subjects re... | [
"• Administer study drug:",
"• Clinical Assessments:",
"• Laboratory Assessments:"
] |
NCT03667690 | 9.4.4 | Days 23–28 | 9.4.4 Days 23–28 - Administer study drug: - o IV infusion of study drug over 60 (±10) minutes (refer to [Section 8.0](#page-68-0) and the Study Pharmacy Manual for additional infusion rate guidance). Administration should occur 24 (±2) hours after study drug was administered on the previous day. OR - o Oral step-down t... | [
"• Laboratory Assessments:"
] |
NCT03667690 | 10.0 | ASSESSMENT OF EFFICACY | 10.0 ASSESSMENT OF EFFICACY Efficacy assessments for all subjects occur on Day 5, Day 14 (±1 day), Day 30 (-2 days), EOT (≤2 days of last dose), and the Follow-up visit (Days 52–59). | [] |
NCT03667690 | 10.1 | Primary Efficacy Outcome | 10.1 Primary Efficacy Outcome The primary efficacy outcome for the FDA is ACM at Day 30 (-2 days). All attempts will be made to determine the survival status of all subjects at Day 30. However, if it is unknown whether a subject is alive or deceased, the subject will be considered deceased for the primary efficacy outc... | [] |
NCT03667690 | 10.2 | Secondary Efficacy Outcomes | 10.2 Secondary Efficacy Outcomes All-cause mortality at Day 30 (-2 days) is a secondary outcome for the EMA, and global cure at Day 14 (±1 day) is a secondary outcome for the FDA. Additional secondary efficacy outcome measures are mycological eradication, clinical cure, and radiological cure (for those subjects with in... | [] |
NCT03667690 | 10.2.1 | Mycological Response | 10.2.1 Mycological Response Table 8: Mycological Response Definitions | MycologicalResponse | Definition | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03667690 | 10.2.2 | Clinical Response | 10.2.2 Clinical Response Table 9: Investigator's Assessment of Clinical Response Definitions | ClinicalResponse | Definition | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Cure | •Resolution of attrib... | [] |
NCT03667690 | 10.2.3 | Radiological Response | 10.2.3 Radiological Response Radiological response is defined in [Table 10.](#page-107-2) Only subjects with invasive candidiasis, with radiologic or other imaging studies at baseline that demonstrate evidence of invasive candidiasis, should be assessed for this outcome. Protocol Amendment 5 Confidential Page 106 of 15... | [] |
NCT03667690 | 10.3 | Exploratory Outcomes | 10.3 Exploratory Outcomes An exploratory efficacy outcome measure is resolution of attributable systemic signs of candidemia and/or invasive candidiasis that were present at baseline. These include fever, hypothermia, hypotension, tachycardia, tachypnea, and local signs of inflammation (i.e., erythema, edema, heat and ... | [] |
NCT03667690 | 11.0 | ASSESSMENT OF PHARMACOKINETIC/PHARMACODYNAMIC PARAMETERS | 11.0 ASSESSMENT OF PHARMACOKINETIC/PHARMACODYNAMIC PARAMETERS Blood samples will be collected from subjects to evaluate the PK of Rezafungin for Injection. Blood samples will be collected from all subjects, but only PK samples from subjects receiving Rezafungin for Injection will be analyzed. Plasma samples will be ana... | [] |
NCT03667690 | 12.0 | ASSESSMENT OF SAFETY | 12.0 ASSESSMENT OF SAFETY | [] |
NCT03667690 | 12.1 | Safety Parameters | 12.1 Safety Parameters Safety will be assessed through the evaluation of AEs, vital signs (temperature, heart rate, blood pressure, and respiratory rate), physical examinations (including neurological examinations), ECGs, and clinical laboratory data (clinical chemistry panels, hematology evaluations, and urinalyses). ... | [] |
NCT03667690 | 12.2 | Adverse Events | 12.2 Adverse Events Adverse Events will be collected for all subjects from informed consent through Follow-up (Days 52–59). The Investigator will assess all AEs and SAEs and will record the following information on the appropriate eCRF page: - Date of onset - Date of resolution or stabilization - Seriousness - AE sever... | [] |
NCT03667690 | 12.3 | Adverse Event Reporting | 12.3 Adverse Event Reporting | [] |
NCT03667690 | 12.3.1 | Notification of Serious Adverse Events | 12.3.1 Notification of Serious Adverse Events The Sponsor has requirements for expedited reporting of SAEs meeting specific criteria to worldwide regulatory authorities in accordance with ICH guidelines and local regulatory requirements. Therefore, the Investigator must notify the Sponsor immediately regarding any SAE ... | [
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection"
] |
NCT03667690 | 12.3.2 | Notification of Adverse Events of Special Interest | 12.3.2 Notification of Adverse Events of Special Interest The Investigator should also alert the Sponsor of any AESI (as described in [Section 12.7\)](#page-115-0) that occurs on the study within 24 hours of awareness by recording the information in the AE eCRF, even if the nature of the AE is deemed non-serious accord... | [] |
NCT03667690 | 12.3.3 | Notification of Emerging Safety Issues | 12.3.3 Notification of Emerging Safety Issues Additionally, the Investigator should alert the Sponsor immediately (under no circumstance should this reporting time exceed 24 hours) by contacting the Medical Monitor of any new findings that necessitate the implementation of urgent safety measures to protect subjects aga... | [] |
NCT03667690 | 12.4 | Definitions | 12.4 Definitions | [] |
NCT03667690 | 12.4.1 | Adverse Event | 12.4.1 Adverse Event An AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (e.g., a clinically-significant abnormal laboratory finding), symptom, or dis... | [
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection"
] |
NCT03667690 | 12.4.2 | Suspected Adverse Reaction | 12.4.2 Suspected Adverse Reaction A suspected adverse reaction is any AE for which there is a reasonable possibility that the drug caused the AE. For the purposes of Investigational New Drug (IND) safety reporting, ''reasonable possibility'' means there is evidence to suggest a causal relationship between the drug and ... | [] |
NCT03667690 | 12.4.3 | Life-Threatening AE or Life-Threatening Suspected Adverse Reaction | 12.4.3 Life-Threatening AE or Life-Threatening Suspected Adverse Reaction An AE or suspected adverse reaction is considered ''life threatening'' if, in the view of either the Investigator or Sponsor, its occurrence places the patient or subject at immediate risk of death. It does not include an AE or suspected adverse ... | [] |
NCT03667690 | 12.4.4 | Serious Adverse Event or Serious Suspected Adverse Reaction | 12.4.4 Serious Adverse Event or Serious Suspected Adverse Reaction An AE or suspected adverse reaction is considered ''serious'' if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: - Death - Life-threatening AE see definition above - Inpatient hospitalization or prolongat... | [] |
NCT03667690 | 12.4.5 | Unexpected AE or Unexpected Suspected Adverse Reaction | 12.4.5 Unexpected AE or Unexpected Suspected Adverse Reaction An AE or suspected adverse reaction is considered ''unexpected'': - If it is not listed in the Investigator's Brochure or is not listed at the nature, severity, frequency, or outcome that has been observed - If an Investigator's Brochure is not required or a... | [] |
NCT03667690 | 12.4.6 | Emerging Safety Issue | 12.4.6 Emerging Safety Issue Any new safety information that may lead to a reassessment of the risk/benefit balance of the investigational product and/or impact subjects' health. Examples include: - Any new safety issue relating to the conduct of the clinical trial that may impact the safety of the trial subjects such ... | [] |
NCT03667690 | 12.4.7 | Urgent Safety Measure | 12.4.7 Urgent Safety Measure An urgent safety measure (USM) is a procedure not defined by the protocol that can be put in place with immediately without prior authorization from Ethics Committees or Regulatory Authorities in order to protect study participants from any immediate hazard to their health and safety. | [] |
NCT03667690 | 12.5 | Adverse Event Classification | 12.5 Adverse Event Classification | [] |
NCT03667690 | 12.5.1 | Relationship to Investigational Drug | 12.5.1 Relationship to Investigational Drug The Investigator's assessment of causality must be provided for all AEs (serious and non-serious) [\(Table 11\)](#page-114-4). An Investigator's causality assessment is the determination of whether there exists a reasonable possibility that the study drug caused or contribute... | [] |
NCT03667690 | 12.5.2 | Severity | 12.5.2 Severity All AEs will be graded for severity using the CTCAE grading criteria (version 5.0). The Investigator will assign a grade to the AE using the CTCAE definitions for Grade 1, Grade 2, Grade 3, Grade 4, or Grade 5. Protocol Amendment 5 Confidential Page 114 of 156 Table 12: Guidelines for Severity Assessmen... | [] |
NCT03667690 | 12.5.3 | Serious Adverse Event | 12.5.3 Serious Adverse Event Any adverse experience occurring at any dose of study medication that occurs between the time of informed consent and the Follow-up visit (Days 52–59) that results in any of the outcomes listed in [Section 12.4.4.](#page-112-2) Hospitalization for a planned or elective procedure or surgery ... | [] |
NCT03667690 | 12.6 | Adverse Event Follow-up | 12.6 Adverse Event Follow-up All unresolved SAEs, AESIs, and study drug-related AEs ("ongoing" at discharge) will be followed by the study staff until resolution or deemed stable, regardless of severity. | [] |
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