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Anti-infective agent
Clofazimine for Mycobacterium Avium Complex Infection
Phase 2
Recruiting
Led By Kevin Winthrop, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet ATS/IDSA 2007 pulmonary disease criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up promis fatigue 7a short form results examined for change from baseline at 24 weeks
Awards & highlights
Study Summary
This trial will test the effectiveness and safety of clofazimine to treat MAC lung disease.
Who is the study for?
Adults over 18 with pulmonary Mycobacterium Avium Complex (MAC) infection, who've had at least two positive MAC sputum cultures in the past year are eligible. They must be able to consent and not have severe lung disease, HIV, active tuberculosis or cancer treatments within a year, high heart rhythm risk (QT prolongation), or use certain drugs.Check my eligibility
What is being tested?
The trial is testing clofazimine's effectiveness and safety against a sugar pill for treating MAC lung disease. Participants will randomly receive either clofazimine or a placebo to compare outcomes between the two groups.See study design
What are the potential side effects?
Clofazimine may cause side effects like stomach pain, nausea, skin discoloration and itching. It can also potentially affect heart rhythms and interact with other medications leading to more serious issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung condition meets specific health standards.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ promis fatigue 7a short form results examined for change from baseline at 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~promis fatigue 7a short form results examined for change from baseline at 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline sputum culture at 24 weeks
Secondary outcome measures
Change from Baseline 6 Minute Walk Test at 24 weeks
C-reactive protein
Change from Baseline CT scan at 24 weeks
+10 moreSide effects data
From 2023 Phase 3 trial • 588 Patients • NCT0240929031%
Metabolism and nutrition disorders
31%
Investigations
9%
Hepatic disorders (SMQ)
9%
Psychiatric disorders
9%
Gastrointestinal disorders
6%
Torsade de pointes/QT prolongation (SMQ)
6%
Hearing and vestibular disorders (SMQ)
6%
Musculoskeletal and connective tissue disorders
3%
Vascular disorders
3%
Pregnancy, puerperium and perinatal conditions
3%
General disorders and administration site conditions
3%
Social circumstances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Regimen A (Long Regimen)
Regimen C (Oral Regimen)
Regimen B (Control Regimen)
Regimen D (6-month Regimen)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: clofazimineExperimental Treatment1 Intervention
Participants receive lamprene
Group II: sugar pillPlacebo Group1 Intervention
Participants receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clofazimine
2022
Completed Phase 4
~2340
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,135 Total Patients Enrolled
University of South FloridaOTHER
412 Previous Clinical Trials
186,957 Total Patients Enrolled
The University of Texas Health Science Center at TylerOTHER
14 Previous Clinical Trials
25,586 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that can affect my heart's rhythm.My lung function is severely reduced.I am currently being treated for active tuberculosis.I haven't had lung cancer treatment or any cancer therapy in the last year.I have had a lung or other solid organ transplant.I have been taking more than 15 mg/day of corticosteroids for over 12 weeks.My doctor thinks I need standard treatment and not just observation due to my severe symptoms or extensive disease.My lung condition meets specific health standards.I am 18 years old or older.I am currently using inhaled antibiotics like amikacin, tobramycin, or gentamicin.I am allergic to or had a severe reaction to clofazimine.I have taken specific antibiotics for MAC in the last 3 months.I have a lung condition with air-filled spaces caused by an infection.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: clofazimine
- Group 2: sugar pill
Awards:
This trial has 0 awards, including: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.
Are there current opportunities to join this experiment?
"The trial is actively seeking participants, after being first posted on April 11th 2017 and last modified on August 18th 2022. This is according to the information provided by clinicaltrials.gov."
Answered by AI
Has any additional research been conducted surrounding Clofazimine?
"In 2016, researchers first began exploring clofazimine at the JSC National Center for Tuberculosis and Lung Diseases. 24 clinical trials have since been completed, while 11 more studies are actively recruiting participants throughout Baton Rouge, Louisiana."
Answered by AI
What adverse effects may be associated with the usage of Clofazimine?
"Taking into consideration the Phase 2 status of Clofazimine, there is evidence to suggest its safety and thus our team at Power assigned it a rating of two."
Answered by AI
What is the current scope of this experimental research?
"At this moment, 4 clinical trial sites have opened enrollment. These are located in Baton Rouge, Philadelphia and Tyler alongside one other city. To reduce the burdens of travel it is suggested to choose a site close by if you decide to join the study."
Answered by AI
How many participants can take part in the experiment at one time?
"Confirmatively, the clinicaltrials.gov website shows that this trial is actively recruiting. This research study was initially posted on April 11th 2017 and has been recently updated as of August 18th 2022. It seeks to recruit 102 patients from 4 different locations."
Answered by AI
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