protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03658889 | 3.1 | General methodology | 3.1 General methodology This is a cross-sectional, non-interventional, national (France), multicentre study, conducted on a population of 300 patients with GCA, to describe GCA management and patient characteristics [\(Figure 1\)](#page-15-0). The study will be conducted in accordance with the professional code of ethi... | [] |
NCT03658889 | 3.2 | Constitution and role of the Scientific Committee | 3.2 Constitution and role of the Scientific Committee A specialised Scientific Committee has been established to advise and support CHUGAI PHARMA FRANCE (CPF), to refine and validate the entire scientific project, including its scientific relevance and its objectives, modalities for selecting physicians and patients, t... | [] |
NCT03658889 | 3.3 | Study duration and provisional schedule | 3.3 Study duration and provisional schedule The planned dates for the study milestones are provided in [Table 1.](#page-16-0) The planned period for recruiting patients will be 5 months, from the 1st of June to the 31th of October 2018. Table 1 Study Milestones | Milestone | Planned Date | |----------------------------... | [] |
NCT03658889 | 3.4 | Physician recruitment and study initiation | 3.4 Physician recruitment and study initiation | [] |
NCT03658889 | 3.4.1 | Definition of the source file for physicians | 3.4.1 Definition of the source file for physicians The physician population in this study will include internists and rheumatologists who manage patients suffering from GCA in hospitals or private clinics in France and agree to take part in the study. A national data base provided by an independent company (CEGEDIM) in... | [] |
NCT03658889 | 3.4.2 | Methods of recruitment of the specialist physicians | 3.4.2 Methods of recruitment of the specialist physicians A mailing including a reply coupon will be sent to all physicians mentioned in Section [3.4.1.](#page-16-1) This mailing will contain information about the study. A telephone follow-up phase is planned for physicians who have not responded to the mailing until t... | [] |
NCT03658889 | 3.4.3 | Recruitment hypotheses | 3.4.3 Recruitment hypotheses The recruitment objective is 150 active physicians (i.e. will include at least one patient). | [] |
NCT03658889 | 3.4.4 | Initiation of the study | 3.4.4 Initiation of the study Following the signature of the study financial contract, physicians will be provided with all the study material (sent by post). The participating physicians will then be trained on the study protocol and its practical aspects by telephone or online (video posted on a website) according to... | [] |
NCT03658889 | 3.5 | Patient selection | 3.5 Patient selection | [] |
NCT03658889 | 3.5.1 | Patient selection method | 3.5.1 Patient selection method Physicians will start patient inclusion only when the study is initiated at their site and when all regulatory authorisations are obtained. It is expected that 300 patients (prevalent or incident cases) will be recruited in this study. Based on the previous EGB database analysis, there ar... | [] |
NCT03658889 | 3.5.2 | Information and consent | 3.5.2 Information and consent The physician must inform the patient about the study before inclusion and seek her/his nonopposition. A patient information form will be given to each patient by the physician. It will explain the purpose of collecting and processing the data, the nature of data collected, the persons who... | [] |
NCT03658889 | 4 | STUDY POPULATIONS | 4 STUDY POPULATIONS | [] |
NCT03658889 | 4.1 | Physician population | 4.1 Physician population In total, 150 internists and rheumatologists practicing in hospitals or private clinics in Metropolitan France are expected to participate actively in the study (i.e. inclusion of at least 1 patient) (see also Section [3.4](#page-16-2) for the physician recruitment method). In order to avoid an... | [] |
NCT03658889 | 4.2 | Patient population | 4.2 Patient population A total of 300 patients meeting the selection criteria listed below will be included in the study. | [] |
NCT03658889 | 4.2.1 | Inclusion criteria | 4.2.1 Inclusion criteria Patients must meet the following criteria to be included in the study: - At least 50 years old. - Suffering from GCA as per investigator judgement, newly diagnosed or not. - Starting or under treatment for GCA. Informed verbally and in writing about this study and not objecting to their data be... | [] |
NCT03658889 | 4.2.2 | Non-inclusion criteria | 4.2.2 Non-inclusion criteria Patients fulfilling the following criteria cannot be included in the study: - Unable to consent - Participation to a randomised controlled clinical trial | [] |
NCT03658889 | 4.2.3 | Withdrawal from the study | 4.2.3 Withdrawal from the study In this cross-sectional study, no specific criteria are defined for withdrawal from the study. The patient can refuse at any time that his/her data are analysed. | [] |
NCT03658889 | 5 | CONDUCT OF THE STUDY AND DATA TO BE COLLECTED | 5 CONDUCT OF THE STUDY AND DATA TO BE COLLECTED | [] |
NCT03658889 | 5.1 | Conduct of the study | 5.1 Conduct of the study | [] |
NCT03658889 | 5.1.1 | Inclusion consultation (single study visit) | 5.1.1 Inclusion consultation (single study visit) Once the study initiation has been completed, patients will be included consecutively after verification that they meet the selection criteria (see section [4.2\)](#page-18-0). The information will be collected during a single visit to the internists and rheumatologist ... | [] |
NCT03658889 | 5.2 | Physician Data collected | 5.2 Physician Data collected The following data will be collected from the physicians who have agreed to participate: Physician location - Gender - Medical specialty - Type of activity: public hospital, private hospital, both hospital and office-based, other - Number of GCA diagnosis within the last previous year - Yea... | [] |
NCT03658889 | 5.3 | Patient Data collected | 5.3 Patient Data collected Patient identity will be coded in the eCRF and the self-assessment questionnaires. Patients will be identified using a number made up of 4 digits: 3 digits for the investigator and 1 digits for the inclusion order number (see also Section [12.5](#page-34-0) on data confidentiality). | [] |
NCT03658889 | 5.3.1 | Case report form | 5.3.1 Case report form No information related to patient identity (initials, full date of birth, etc) will be entered in the eCRF. The following information will be recorded in the eCRF using the data available in the medical file or collected during the visit (as part of the routine patient management): - Date of the ... | [
"GCA patient journey:",
"GCA characteristics:",
"o Clinical form:",
"GCA activity:",
"Treatments:"
] |
NCT03658889 | 5.3.2 | Questionnaires | 5.3.2 Questionnaires Four paper questionnaires will be completed by the patient and one will be completed by the physician. All questionnaires will be returned in the pre-paid reply envelope to the CRO ITEC Services, in charge of the data entry. | [] |
NCT03658889 | 5.3.2.1 | Self-assessment patient questionnaires: | 5.3.2.1 Self-assessment patient questionnaires: - SF-36 (McHorney, Ware, et Raczek 1993; Ware et Sherbourne 1992): The SF-36 questionnaire is a generic health status instrument evaluating 8 dimensions through 36 questions: physical functioning, bodily pain, role limitations due to physical health problems, role limitat... | [] |
NCT03658889 | 5.3.2.2 | Physician questionnaire: | 5.3.2.2 Physician questionnaire: Physician global arteritis activity VAS: This VAS measures global arteritis activity, as described above. The physician will be asked to indicate the patient disease activity by drawing a line on the scale. | [] |
NCT03658889 | 6 | ENDPOINTS | 6 ENDPOINTS | [] |
NCT03658889 | 6.1 | Primary endpoints | 6.1 Primary endpoints The endpoints of the primary objective To describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis are: - Patient journey (Proportions of each physicians who referred the patient, Proportions of each physicians who ... | [] |
NCT03658889 | 6.2 | Secondary endpoints | 6.2 Secondary endpoints The endpoints of the objective To describe comorbidities related to GCs and associated treatments are: - Comorbidities related to GCs - Treatments in patients with comorbidities related to GCs The endpoints of the objective To describe GCA characteristics in terms of GCA duration, initial presen... | [
"The endpoints of the objective To describe the health status of GCA patients are:",
"The endpoints of the objective To describe physician and patient characteristics are:"
] |
NCT03658889 | 7 | STATISTICAL METHODS | 7 STATISTICAL METHODS | [] |
NCT03658889 | 7.1 | Rationale for the number of patients and physicians | 7.1 Rationale for the number of patients and physicians | [] |
NCT03658889 | 7.1.1 | Number of patients required | 7.1.1 Number of patients required Not applicable in a descriptive observational study | [] |
NCT03658889 | 7.1.2 | Number of physicians | 7.1.2 Number of physicians Not applicable | [] |
NCT03658889 | 7.2 | Statistical analyses | 7.2 Statistical analyses The analysis will be performed by ITEC Services in accordance with this section and with the Statistical Analysis Plan (SAP) that supplements it. | [] |
NCT03658889 | 7.2.1 | General statistical methods | 7.2.1 General statistical methods The statistical analysis will be performed using SAS® software, version 9.3 or upper. A SAP describing the planned statistical analysis in detail with Tables, Figures and Listings (TFLs) templates will be developed as a separate document. This SAP will be finalised and validated before... | [] |
NCT03658889 | 7.2.2 | Study populations | 7.2.2 Study populations Three populations will be defined for the analyses: - Population of Physicians: all the specialists who have included at least one patient meeting the eligibility criteria for the study - Total Population: all included patients - Analysis Population: all included patients meeting the inclusion a... | [] |
NCT03658889 | 7.2.3 | Analysis of the physician and patient populations | 7.2.3 Analysis of the physician and patient populations The analyses of the primary and secondary objectives will be performed on the Analysis Population. | [] |
NCT03658889 | 7.2.3.1 | Analyses of primary objectives: | 7.2.3.1 Analyses of primary objectives: To describe medical practices in patients with GCA, the following endpoints will be described on the analysis population:
Patient journey - Proportions of each physician who referred the patient - Proportions of each physician who follows the patient for his/her GCA (internist/r... | [
"Patient journey",
"Diagnostic mean",
"Previous and on-going specific GCA treatments since diagnosis"
] |
NCT03658889 | 7.2.3.2 | Analyses of secondary objectives | 7.2.3.2 Analyses of secondary objectives The analysis of the secondary objectives will be performed on the analysis population.
Description of comorbidities related to GCs and associated treatments - Current and past comorbidities of GCA patients (comorbidities related to GCs) will be coded using the medical dictionar... | [
"Description of comorbidities related to GCs and associated treatments",
"Description of GCA characteristics",
"Description of the health status of GCA patients",
"SF-36 questionnaire",
"EQ5D-3L questionnaire",
"FACIT-Fatigue",
"Description of physician and patient characteristics",
"Description of ph... |
NCT03658889 | 7.2.4 | Schedule for data analysis | 7.2.4 Schedule for data analysis The final analyses will be performed after the database lock and are planned for January 2019. | [] |
NCT03658889 | 8 | DATA MONITORING AND CONTROL | 8 DATA MONITORING AND CONTROL | [] |
NCT03658889 | 8.1 | Centralised monitoring and controls | 8.1 Centralised monitoring and controls Monitoring of the study will be performed by ITEC Services, which will ensure, through regular communication (follow-up telephone calls and/or sending out newsletters) that the study is being conducted in accordance with the protocol and the regulatory requirements. Monitoring vi... | [] |
NCT03658889 | 8.2 | Audit and on-site inspections | 8.2 Audit and on-site inspections Prior to the start of the study, the investigator is required to confirm his/her agreement to conduct the study in accordance with the protocol and to give access to all relevant data and records to CPF monitors, auditors, and designated agents of CPF, IRBs/IECs, and regulatory authori... | [] |
NCT03658889 | 9 | LIMITATIONS OF THE STUDY | 9 LIMITATIONS OF THE STUDY In order to extrapolate study results to the entire population, potential bias must be detected a priori and controlled as much as possible. In this cross-sectional study, the description of patient management can be subject to selection bias during the recruitment of the study population (if... | [] |
NCT03658889 | 9.1 | Bias in selection of the physicians and the patients during recruitment | 9.1 Bias in selection of the physicians and the patients during recruitment | [] |
NCT03658889 | 9.1.1 | Pre-inclusion controls | 9.1.1 Pre-inclusion controls | [] |
NCT03658889 | 9.1.1.1 | Selection of physicians | 9.1.1.1 Selection of physicians The physician selection method described in Section [3.4](#page-16-2) should ensure the sample is representative. | [] |
NCT03658889 | 9.1.1.2 | Patient selection | 9.1.1.2 Patient selection The patients included should be selected in a consecutive manner by the participating physicians once the study has been initiated and the selection criteria have been verified. In order to encourage inclusions in a consecutive manner, this obligation will be highlighted: - in the financial co... | [] |
NCT03658889 | 9.1.2 | Post-inclusion controls | 9.1.2 Post-inclusion controls At the end of the inclusion period, the characteristics of the physicians who are active in the study will be compared to those of the physicians in the source list, on the basis of the available data. Any significant differences in these parameters will be discussed with the members of th... | [] |
NCT03658889 | 10 | REPORTING OF ADVERSE REACTIONS | 10 REPORTING OF ADVERSE REACTIONS This is a non-interventional epidemiological study. It does not aim to identify or quantify any safety risk related to an authorised medicine. Therefore, no safety data will be collected and no reporting of adverse reactions is expected in this study. Physicians will report adverse eve... | [] |
NCT03658889 | 11 | STUDY DISCONTINUATION | 11 STUDY DISCONTINUATION Planned study duration is 4 months (recruitment period and data collection). Given the crosssectional nature of the study, no study discontinuation is expected. If the patient withdraws her/his consent after the unique visit, all data generated until study discontinuation and the reasons for no... | [] |
NCT03658889 | 12 | ETHICAL AND LEGAL CONSIDERATIONS | 12 ETHICAL AND LEGAL CONSIDERATIONS | [] |
NCT03658889 | 12.1 | Regulatory framework of the study | 12.1 Regulatory framework of the study This non-interventional study is conducted in accordance with Article L. 1121-1 of the French Code of Public Health defining non-interventional studies as "all the acts are practised and products used in the usual way, with no risk and constraint for the patient". This study does ... | [] |
NCT03658889 | 12.2 | Responsibility and insurance by CHUGAI PHARMA FRANCE | 12.2 Responsibility and insurance by CHUGAI PHARMA FRANCE In France, since this study does not fall within the framework of biomedical research, no insurance is required. | [] |
NCT03658889 | 12.3 | Submission of the study contracts and protocol | 12.3 Submission of the study contracts and protocol Before the start of the study, the study protocol, the patient information form and all the other relevant documents will be submitted to the competent authorities in accordance with applicable legislation. All ethical and legal obligations must be met before the firs... | [] |
NCT03658889 | 12.3.1 | Ethics Committee | 12.3.1 Ethics Committee Pursuant to Law No. 2012-300 of March 5, 2012 on research involving humans (known as "Loi Jardé"), the study will be submitted to an Ethics Committee. | [] |
NCT03658889 | 12.3.2 | Protection of personal data | 12.3.2 Protection of personal data In accordance with Article 54 of Act No 78-17 of January 6, 1978 as amended, the processing of personal data for this non-interventional study is in accordance with Decision No 2016-263 of July 21, 2016 on the approval of a reference methodology for the processing of personal data use... | [] |
NCT03658889 | 12.3.3 | Submission of financial agreements to Medical Council | 12.3.3 Submission of financial agreements to Medical Council According to the Act on various social measures (DMOS - amended by the law of March 4, 2002), Article L. 4113-6 of the French Code of Public Health (CSP) prohibits companies "benefiting, producing or marketing products covered by compulsory social security sc... | [] |
NCT03658889 | 12.3.4 | Sunshine act | 12.3.4 Sunshine act In accordance with Article L. 1453-1 of the French Code of Public Health (Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products) and Decree no. ° 2013-414 of May 21, 2013, CPF will disclose any agreements with healthcare profess... | [] |
NCT03658889 | 12.4 | Protocol amendment(s) | 12.4 Protocol amendment(s) Neither the physician nor CPF is permitted to amend the study protocol without obtaining the written agreement of the other party. Once the study has started, amendments should only be made in exceptional circumstances. The amendments then become an integral part of the study protocol. In acc... | [] |
NCT03658889 | 12.5 | Information for patients and confidentiality of the collected data | 12.5 Information for patients and confidentiality of the collected data Before entering the study, the physician must inform the patient, using a vocabulary that the patient can understand, of the nature and objective(s) of the study and of the right to object to, access and correct his/her data. The physician will giv... | [] |
NCT03658889 | 12.6 | Rationale for the use of personal data | 12.6 Rationale for the use of personal data The use of indirectly personally identifiable data is crucial in this study since it will allow quality control. Physicians may be requested written corrections for missing or inconsistent data essential to the study. | [] |
NCT03658889 | 12.7 | Financial agreement with the physicians | 12.7 Financial agreement with the physicians The physician and ITEC Services (appointed by CPF) will sign a specific financial agreement prior to the study, detailing all the responsibilities incumbent upon CPF and the physician, in relation to the study. Compensation will be provided for each patient included; the ter... | [] |
NCT03658889 | 12.8 | Delegation of duties by the physician | 12.8 Delegation of duties by the physician The physician must ensure that all persons collaborating in the study have all the necessary information concerning the protocol, any potential amendments, as well as their duties and functions in the study. | [] |
NCT03658889 | 12.9 | Archiving | 12.9 Archiving The key documents, as listed below, must be stored by the physician in a secure location that allows quick access if necessary. By signing the protocol, the investigator agrees to store these for a period of 5 years. However, a longer period could possibly be imposed by new regulatory requirements. Key d... | [] |
NCT03658889 | 13 | DOCUMENTATION AND USE OF THE STUDY RESULTS | 13 DOCUMENTATION AND USE OF THE STUDY RESULTS | [] |
NCT03658889 | 13.1 | Documentation of the study results | 13.1 Documentation of the study results | [] |
NCT03658889 | 13.1.1 | Documents completed by the physician | 13.1.1 Documents completed by the physician ITEC Services, appointed by CPF, will provide each physician, in a timely manner, with a sufficient quantity of all the documents needed to collect the study data. The physician will enter into the eCRF all data collected from medical files as part of the protocol. The method... | [] |
NCT03658889 | 13.1.2 | Documents completed by the patient | 13.1.2 Documents completed by the patient After having been informed of the study by the physician, and if he/she agrees to participate, the patient will be asked to complete the 4 self-assessment questionnaires described in Section [5.3.2.](#page-23-0) | [] |
NCT03658889 | 13.1.3 | Study report | 13.1.3 Study report ITEC Services will produce a final study report in collaboration with CPF. The complete report (statistical and clinical) will be validated by the lead physician for the project at CPF and by the study Scientific Committee. | [] |
NCT03658889 | 13.2 | Use of the study results | 13.2 Use of the study results All the information related to the operations of CPF and as yet unpublished scientific data provided by CPF is confidential and remains the sole property of CPF. The physician undertakes to use this information solely for the conduct of the study and not for any other reason, except with p... | [] |
NCT03658889 | 14 | BIBLIOGRAPHICAL REFERENCES | 14 BIBLIOGRAPHICAL REFERENCES - Babigumira, Joseph B., Meng Li, Denise M. Boudreau, Jennie H. Best, et Louis P. Garrison. 2017. « Estimating the Cost of Illness of Giant Cell Arteritis in the United States ». Rheumatology and Therapy 4 (1): 111‑19. https://doi.org/10.1007/s40744-017-0052- 8. - Bienvenu, B., K. H. Ly, M... | [] |
NCT03658889 | 15 | APPENDICES | 15 APPENDICES 15.1 Appendix 1: 36-Item Short Form Survey Instrument (SF-36) | [] |
NCT03658889 | 15.2 | Appendix 2: EuroQol-5 Dimensions - 3 Level version (EQ-5D-3L) | 15.2 Appendix 2: EuroQol-5 Dimensions - 3 Level version (EQ-5D-3L) | [] |
NCT03658889 | 15.3 | Appendix 3: FACIT Fatigue Scale | 15.3 Appendix 3: FACIT Fatigue Scale | [] |
NCT03658889 | 15.4 | Appendix 4: Global Arteritis Activity Scale (VAS) | 15.4 Appendix 4: Global Arteritis Activity Scale (VAS) Could you please indicate the arteritis activity by placing a vertical mark on the line between "no disease activity" and "maximum disease activity"? | No | | |----------|-----------------| | disease | Maximum disease | | | activity | | activity | | | [] |
NCT03667690 | 1.0 | PROTOCOL SYNOPSIS | 1.0 PROTOCOL SYNOPSIS Sponsor: Cidara Therapeutics, Inc., San Diego, California, USA Product Name: Rezafungin for Injection Active Ingredients: rezafungin acetate Protocol Title: A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection versus Intravenous Caspofungin ... | [
"Objectives:",
"Study Design and Methodology:",
"Challenges in Conducting a Pivotal Phase 3 Study During the COVID-19 Pandemic:",
"Subjects Randomized to Rezafungin for Injection",
"Subjects Randomized to Caspofungin",
"End of Treatment Visit and Follow-up Visits",
"Mycological Diagnosis",
"Retinal Ex... |
NCT03667690 | 3.0 | LIST OF ACRONYMS, ABBREVIATIONS, AND DEFINITIONS OF TERMS | 3.0 LIST OF ACRONYMS, ABBREVIATIONS, AND DEFINITIONS OF TERMS | ACM | all-cause mortality | |-----------|------------------------------------------------------------------------------------------| | ADL | activities of daily living | | AE | adverse event | | AESI | adverse event of special interest | | ANC | absolute n... | [
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection",
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection"
] |
NCT03667690 | 4.0 | BACKGROUND AND RATIONALE | 4.0 BACKGROUND AND RATIONALE | [] |
NCT03667690 | 4.1 | Candidemia and Invasive Candidiasis | 4.1 Candidemia and Invasive Candidiasis Rezafungin for Injection, a new echinocandin antifungal agent, is being developed to treat patients with systemic infections caused by Candida species (spp.). These serious and life-threatening infections represent a significant public health issue, particularly in highly vulnera... | [] |
NCT03667690 | 4.2 | Rezafungin for Injection | 4.2 Rezafungin for Injection Rezafungin is a novel semi-synthetic echinocandin synthesized from a fermentation product of Aspergillus nidulans that is administered by IV infusion. Protocol Amendment 5 Confidential Page 33 of 156
Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection Rezafungin is... | [
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection"
] |
NCT03667690 | 4.3 | Nonclinical Efficacy Models | 4.3 Nonclinical Efficacy Models A series of studies in the neutropenic mouse systemic candidiasis model show that rezafungin is efficacious when administered by either the IV, intraperitoneal (IP) or subcutaneous (SC) route across a wide range of doses. Dose-dependent reductions of C. albicans kidney burden have been o... | [] |
NCT03667690 | 4.4 | Nonclinical Pharmacokinetics | 4.4 Nonclinical Pharmacokinetics Rezafungin was found to be stable in liver microsomes from all spp. tested. A cross-species stability study also determined that rezafungin is stable in intestinal microsomes and no metabolic products were identified during incubations of rezafungin with mouse, rat, monkey, or human liv... | [] |
NCT03667690 | 4.5 | Nonclinical Pharmacology and Toxicology | 4.5 Nonclinical Pharmacology and Toxicology The summary of nonclinical information is considered accurate as of the date of this protocol amendment. The Investigator's Brochure should be referenced for additional details or updated information throughout the study. Protocol Amendment 5 Confidential Page 37 of 156 An ov... | [] |
NCT03667690 | 4.5.1 | Safety Pharmacology | 4.5.1 Safety Pharmacology The summary of safety pharmacology information provided in the protocol is considered accurate as of the date of this protocol amendment. The Investigator's Brochure should be referenced for additional details or updated information throughout the conduct of the study. In the safety pharmacolo... | [] |
NCT03667690 | 4.5.2 | Nonclinical Toxicology | 4.5.2 Nonclinical Toxicology The summary of nonclinical toxicology information provided in the protocol is considered accurate as of the date of this protocol amendment. The Investigator's Brochure should be referenced for additional details or updated information throughout the conduct of the study. Nonclinical safety... | [] |
NCT03667690 | 4.6 | Clinical Pharmacology | 4.6 Clinical Pharmacology The summary of clinical pharmacology information provided in the protocol is considered accurate as of the date of this protocol amendment. The Investigator's Brochure should be referenced for additional details or updated information throughout the conduct of the study. Protocol Amendment 5 C... | [
"Long Half-Life and Dose-Proportional",
"Lack of Drug-Drug Interactions",
"Elimination Primarily Non-Renal, with Inactive Metabolites Excreted in Urine",
"No Effect on QT Interval",
"Mild Increased Photosensitivity"
] |
NCT03667690 | 4.7 | Overview of Clinical Experience | 4.7 Overview of Clinical Experience The summary of clinical safety and efficacy information provided in the protocol is considered current and accurate as of the date of this protocol amendment. The Investigator's Brochure should be referenced for additional details or updated information throughout the conduct of the ... | [] |
NCT03667690 | 4.7.1 | Overview of Clinical Safety | 4.7.1 Overview of Clinical Safety In the Phase 2 STRIVE study (CD101.IV.2.03), there were no notable differences in TEAEs across the study groups. Between the rezafungin groups, there were no dose-related patterns in study drug-related TEAEs, severe TEAEs, serious adverse events (SAEs), related SAEs, or SAEs leading to... | [] |
NCT03667690 | 4.7.2 | Overview of Clinical Efficacy | 4.7.2 Overview of Clinical Efficacy In the Phase 2 STRIVE study, demographics were generally balanced across the groups with no differences in sex, race, ethnicity, or age that would appreciably affect clinical efficacy. Diagnosis at study entry was 79.2% candidemia and 20.8% invasive candidiasis with reasonable balanc... | [] |
NCT03667690 | 4.8 | Summary of Benefits and Risks | 4.8 Summary of Benefits and Risks | [] |
NCT03667690 | 4.8.1 | Known Benefits | 4.8.1 Known Benefits There are no known benefits of treatment with Rezafungin for Injection as of the date of the original protocol for this study. The therapeutic benefits of caspofungin and fluconazole for the treatment of fungal infections are documented in the prescribing information and published literature. Appro... | [] |
NCT03667690 | 4.8.2 | Potential Benefits | 4.8.2 Potential Benefits In the Phase 2 STRIVE study, efficacy for Rezafungin for Injection was comparable to standard of care at Day 14 for all endpoints. | [] |
NCT03667690 | 4.8.3 | Known Risks | 4.8.3 Known Risks Infusion reactions characterized by flushing, shortness of breath, and nausea have been observed with rezafungin and are similar to infusion reactions noted with other echinocandins. Symptoms of the infusion reaction may resolve without intervention or with either slowing of the infusion rate or inter... | [] |
NCT03667690 | 4.8.4 | Potential Risks | 4.8.4 Potential Risks Echinocandins are typically well tolerated [\(Eraxis \[anidulafungin\] Prescribing Information;](#page-136-1) [Mycamine \[micafungin sodium\] Prescribing Information;](#page-137-0) [Cancidas \[caspofungin acetate\]](#page-135-0) [Prescribing Information\)](#page-135-0). Potential drug class effect... | [] |
NCT03667690 | 4.8.5 | Mitigation of Risks | 4.8.5 Mitigation of Risks Due to findings of toxicity at elevated exposures in nonclinical toxicology studies and AEs noted in clinical studies, special measures have been instituted in this protocol. For the risk of an infusion reaction typically associated with echinocandins, the option to slow the infusion rate to a... | [] |
NCT03667690 | 4.9 | Justification for Dosing Regimen | 4.9 Justification for Dosing Regimen | [] |
NCT03667690 | 4.9.1 | Rezafungin for Injection | 4.9.1 Rezafungin for Injection A population PK model has been developed for rezafungin [\(Lakota 2018\)](#page-137-7). Data from a subset of Phase 2 Part A data as well as data from a Phase 1 study was added to update the structural model and evaluate covariate effects. Preliminary data from the modeling was used to se... | [
"Cidara Therapeutics, Inc. Protocol CD101.IV.3.05 A5 Rezafungin for Injection"
] |
NCT03667690 | 4.9.2 | Caspofungin with Option for Oral Step-Down Regimen of Fluconazole | 4.9.2 Caspofungin with Option for Oral Step-Down Regimen of Fluconazole Treatment regimens with caspofungin and fluconazole are consistent with standard of care regimens in approved labeling [\(Cancidas \[caspofungin acetate\] Prescribing Information;](#page-135-0) [Diflucan \[fluconazole\] tablets Prescribing Informat... | [] |
NCT03667690 | 4.10 | Population to be Studied | 4.10 Population to be Studied Adult subjects with candidemia and/or invasive candidiasis. Protocol Amendment 5 Confidential Page 50 of 156 a Shaded cells indicate PK-PD target attainment values ≥90%. b Bolded values represent the susceptible breakpoints for each agent against the respective Candida spp. c Cells with bo... | [] |
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