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Antibiotic
RHB-204 for MAC Lung Infection (CleaR-MAC Trial)
Phase 3
Waitlist Available
Research Sponsored by RedHill Biopharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have symptoms of MAC lung infection that include one of the following: respiratory symptoms such as chronic cough, excessive mucous production, fatigue, dyspnea, hemoptysis or systemic symptoms such as fever, night sweats or loss of appetite.
Have a MAC lung infection documented by one MAC positive culture within 18 months prior to screening and a MAC positive culture at screening (cultures need to be at least 1 month apart).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 months
Awards & highlights
CleaR-MAC Trial Summary
This trial is testing a new drug to treat MAC lung infection in people with bronchiectasis.
Who is the study for?
Adults aged 18-85 with MAC lung infection, showing symptoms like chronic cough or night sweats, and not treated for MAC in the last 6 months can join. They must weigh over 90 pounds and have a CT scan showing specific lung changes within the past 6 months.Check my eligibility
What is being tested?
The trial is testing RHB-204 against a placebo to see if it's effective and safe for treating pulmonary Mycobacterium Avium Complex disease. Participants are randomly assigned to either the drug or placebo group in a double-blind setup.See study design
What are the potential side effects?
While specific side effects of RHB-204 aren't listed here, common ones may include digestive issues, potential allergic reactions, liver enzyme changes, and possibly others as seen with antibiotics used for similar infections.
CleaR-MAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms like chronic cough, fatigue, or night sweats due to a MAC lung infection.
Select...
I have had two positive MAC lung infection tests at least a month apart, one within the last 18 months.
Select...
I weigh more than 90 pounds.
Select...
I have had two positive tests for MAC lung infection, one within the last 18 months and another at screening.
CleaR-MAC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 19 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of Life Questionnaire - Bronchiectasis (QoL B) Respiratory Symptoms domain score from baseline to Month 6 for RHB-204 compared to placebo
Sputum culture conversion (SCC)
Secondary outcome measures
Part 1 Secondary efficacy objective - Improvement in Physical Functioning
Part 1 Secondary efficacy objective - Reduction of fatigue
Part 1 Secondary efficacy objective - Time to culture conversion
+8 moreCleaR-MAC Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RHB-204Experimental Treatment1 Intervention
Each capsule contains clarithromycin 158.3mg; rifabutin 40mg; clofazimine 13.3mg.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will contain riboflavin, a type of B vitamin, which may discolor urine in a similar fashion as RHB-204.
Find a Location
Who is running the clinical trial?
RedHill Biopharma LimitedLead Sponsor
19 Previous Clinical Trials
2,945 Total Patients Enrolled
Kevin L. Winthrop, MD, MPHStudy DirectorOregon Health and Science University
June L Almenoff, MD, PhDStudy ChairRedHill Biopharma, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a MAC lung infection with signs on my recent chest CT scan.You have cystic fibrosis or have had an organ or bone marrow transplant.I have been treated for lung disease with specific drugs in the last 6 months.I am between 18 and 85 years old.You have had a bad reaction to clarithromycin, rifabutin, or clofazimine before.I have symptoms like chronic cough, fatigue, or night sweats due to a MAC lung infection.I have a history of irregular heartbeats or a family history of Long QT syndrome.The time it takes for your heart to beat is too long when measured on an ECG.I have not been treated for MAC in the last 6 months.You have large hollow areas in your lungs seen on a chest CT scan.I am scheduled for lung surgery due to MAC lung disease.I have had two positive MAC lung infection tests at least a month apart, one within the last 18 months.I weigh more than 90 pounds.My infection is resistant to standard antibiotics.I need to use supplemental oxygen regularly.I am currently using an inhaled medication that contains amikacin, tobramycin, or gentamicin.I have had two positive tests for MAC lung infection, one within the last 18 months and another at screening.
Research Study Groups:
This trial has the following groups:- Group 1: RHB-204
- Group 2: Placebo
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Pulmonary MAC Infection Patient Testimony for trial: Trial Name: NCT04616924 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for this trial 50 years or older?
"The age range for this study is 18 to 85 years old."
Answered by AI
Can people with the relevant medical conditions enroll in this clinical trial at this time?
"Yes, this trial is open and currently enrolling patients. According to the listing on clinicaltrials.gov, the trial was posted on December 1st, 2020 and was edited on July 28th, 2022. They are looking for 125 patients at 25 different sites."
Answered by AI
Could you explain the goals of this experiment?
"The primary outcome of this study, as stated by the sponsor, RedHill Biopharma Limited, will be Sputum culture conversion (SCC), which will be measured over the course of 6 months. This study will also measure secondary outcomes, including the proportion of subjects with SCC by Month 6 who sustain negative sputum cultures at Month 16 and negative sputum culture at Month 19 (3 months off treatment) for RHB-204 compared to placebo (durable responders), the mean change in the Short Form 36 Physical Functioning domain score from baseline to Month 19 for ex-RHB-204 compared to ex-"
Answered by AI
For what reason is RHB-204 most often prescribed?
"RHB-204 is effective in treating bacterial infections, mycobacterial infections, acute bacterial exacerbation of chronic bronchitis (abecb), and hiv."
Answered by AI
Could you please list how many hospitals are testing this new medical treatment?
"There are 25 sites for this clinical trial, which are located in Palm Springs, Farmington, Atlanta, and other places. If you choose to participate in the trial, it would be best to select a site that is close to your location to minimize travel."
Answered by AI
What is the existing body of research on RHB-204?
"RHB-204 was first studied in 2004 at the National Cancer Center in South Korea. As of now, there have been 18,457 completed clinical trials worldwide. Out of the 48 active clinical trials, many are based in Palm Springs, California."
Answered by AI
Who else is applying?
What state do they live in?
California
Pennsylvania
Louisiana
How old are they?
18 - 65
65+
What site did they apply to?
Medical Facility
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Untreated in new treatment. I have not been treated yet and would like to aide in research.
PatientReceived 2+ prior treatments
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