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Echinocandin Antifungal
Rezafungin for Prevention of Fungal Infections (ReSPECT Trial)
Phase 3
Recruiting
Research Sponsored by Cidara Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with specific underlying diseases including acute myeloid leukemia (AML), acute lymphoblastic leukemia, acute undifferentiated leukemia, acute biphenotypic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, lymphoma, aplastic anemia, myelofibrosis, chronic myelomonocytic leukemia, chronic lymphocytic leukemia, drepanocytosis, red blood cell aplasia, myeloproliferative disorder, unclassified, and multiple myeloma
Receiving myeloablative or reduced-intensity conditioning regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 (±1 day), day 28 (±1 day), day 60 (±5 days), day 90 (±7 days), and day 120 (±7 days)
Awards & highlights
ReSPECT Trial Summary
This trial will compare the effectiveness of Rezafungin to the standard regimen in preventing fungal diseases.
Who is the study for?
Adults over 18 with certain blood diseases like leukemia or lymphoma, undergoing bone marrow transplants, can join this trial. They must have good kidney and liver function, agree to birth control measures if applicable, and not have had recent fungal infections or other specific health issues.Check my eligibility
What is being tested?
The study is testing Rezafungin's effectiveness in preventing invasive fungal diseases during bone marrow transplantation compared to standard antifungal drugs like Posaconazole and Fluconazole.See study design
What are the potential side effects?
Rezafungin may cause potential side effects such as allergic reactions, liver enzyme changes, gastrointestinal symptoms (nausea/vomiting), headache, infusion-related reactions, and possibly affect the heart rhythm.
ReSPECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific blood-related disease.
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I am undergoing intense or moderate bone marrow preparation treatment.
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I agree to follow the required contraception measures.
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I am receiving a bone marrow transplant from a matched or partially matched donor.
ReSPECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14 (±1 day), day 28 (±1 day), day 60 (±5 days), day 90 (±7 days), and day 120 (±7 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 (±1 day), day 28 (±1 day), day 60 (±5 days), day 90 (±7 days), and day 120 (±7 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Noninferior Fungal-Free Survival (US FDA)
Superior Fungal-Free Survival (EMA)
Secondary outcome measures
Compare Discontinuation for Toxicity or Intolerance
Compare Fungal-Free Survival with or without a Diagnosis of Clinically Significant GVHD
Compare Mortality
+3 moreOther outcome measures
Compare Antifungal Prophylaxis
Compare Incidence of IFD
Compare Infections Caused by TMP/SMX-Sensitive Organisms
+14 moreReSPECT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: Rezafungin for InjectionExperimental Treatment3 Interventions
Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 13 weeks. Subjects will receive oral placebo for standard antimicrobial regimen (SAR) azole prophylaxis and oral placebo for SAR anti-Pneumocystis pneumonia (PCP) prophylaxis in accordance with the respective SAR dosing regimens for each. For subjects who are switched to a SAR IV regimen, oral placebo for SAR azole prophylaxis will be changed to IV placebo. There is no IV option for SAR anti-PCP prophylaxis.
Group II: Group 2: Oral AntifungalActive Control3 Interventions
Subjects in SAR treatment group will receive 400 mg oral fluconazole once daily for 13 weeks. Fluconazole may be switched, due to acute clinically significant graft versus-host disease (GVHD), to 300 mg oral posaconazole twice daily on the first day of the medication switch and 300 mg once daily, thereafter. However, subjects who are switched to posaconazole cannot be switched back to fluconazole. Azole-based antifungal therapy (fluconazole or posaconazole) can be switched from daily oral therapy to daily IV therapy at the discretion of the Investigator. In addition, subjects in the SAR group will receive anti-PCP prophylaxis with oral TMP/SMX (80 mg TMP/400 mg SMX) once daily. There is no IV option for SAR anti-PCP prophylaxis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Placebo
2017
Completed Phase 4
~3500
Rezafungin for Injection
2018
Completed Phase 3
~200
Intravenous Placebo
2016
Completed Phase 3
~2150
Find a Location
Who is running the clinical trial?
Cidara Therapeutics Inc.Lead Sponsor
10 Previous Clinical Trials
1,785 Total Patients Enrolled
Taylor Sandison, MD, MPHStudy DirectorCidara Therapeutics Inc.
1 Previous Clinical Trials
199 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma has not responded to chemotherapy.I have been diagnosed with heart failure that causes symptoms.I am 18 years old or older.My lung function is below normal levels.I am taking medication that could severely affect my nervous system.I am not taking any medication or supplement that badly interacts with standard infection treatments.You have tested positive for certain substances in your blood within 14 days before the transplant.I have been diagnosed with a specific blood-related disease.I agree to use birth control as required by the study.I have had a bone marrow transplant from a donor.I have had PCP within the last 2 years.I have a severe movement disorder or nerve damage.I am HIV positive.You or someone in your family has a history of a long QT interval on an ECG.My AML is not currently in remission.I experience significant unsteadiness, shaking, or numbness.I have or might have a fungal infection diagnosed in the last 4 weeks.My kidney and liver are functioning well.I am undergoing intense or moderate bone marrow preparation treatment.I am scheduled for a stem cell transplant using my own cells.I agree to follow the required contraception measures.I am scheduled to receive a cord blood transplant.I am receiving a bone marrow transplant from a matched or partially matched donor.I have been diagnosed with liver cirrhosis.My body weight is over 130 kilograms.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Oral Antifungal
- Group 2: Group 1: Rezafungin for Injection
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What indications are ameliorated by the use of Group 1: Rezafungin for Injection?
"Bone marrow transplantation is typically addressed with Group 1: Rezafungin for Injection. This prescription drug also helps treat other ailments such as candida intertrigo, cholera, and fungal infection of the skin."
Answered by AI
Has the FDA sanctioned Rezafungin for Injection to be used by Group 1?
"Our team has given Group 1: Rezafungin for Injection a risk rating of 3, as the Phase 3 trial indicates that there is ample evidence to support its safety and efficacy."
Answered by AI
How many participants have been enrolled in this clinical trial?
"Affirmative. Clinicaltrials.gov states that the trial, which was initially posted on May 11th 2020 and last edited January 20th 2022, is actively seeking volunteers. 462 individuals must be recruited from two locations."
Answered by AI
Has there been any other research conducted with Rezafungin for Injection within Group 1?
"Currently, 44 trials concerning Group 1: Rezafungin for Injection are underway. Of these, 11 have advanced to Phase 3. Though the majority of studies centre in Birmingham, Alabama there are 231 other sites actively running this trial around the world."
Answered by AI
What is the primary focus of this medical experiment?
"According to Cidara Therapeutics Inc., the primary outcome, observed over a 90 day period (±7 days), is Noninferior Fungal-Free Survival as defined by the US FDA. Additionally, this study will assess particular health economics variables such as antibiotic therapy use and severity of GVHD. Furthermore, it aims to compare infection rates caused by TMP/SMX-sensitive organisms like Toxoplasma gondii and Nocardia spp between Rezafungin for Injection and control groups."
Answered by AI
Are there opportunities for participants to join this research endeavor?
"According to information available on clinicaltrials.gov, this medical experiment is currently in search of participants. It was originally posted on May 11th 2020 and updated for the last time on January 20th 2022."
Answered by AI
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