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Nontuberculous Mycobacteria clinical trials at UCSF

4 in progress, 1 open to eligible people

Nontuberculous mycobacteria are bacteria that can infect the lungs. UCSF is studying the effects of an inhaled drug called Clofazimine to determine its safety and effectiveness. This research is part of ongoing efforts to improve treatment for lung infections.

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  • ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment with MNKD-101, Clofazimine Inhalation Suspension

    open to eligible people ages 18-85

    This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)

    Fresno, California and other locations

  • Lamprene Multiple Patient Program

    Sorry, not accepting new patients

    Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM). To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.

  • Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

    Sorry, in progress, not accepting new patients

    NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and hematologic toxicity. To date, most of the evidence underlying the current treatment recommendations has come from observational studies in which either a macrolide has been combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The proposed study will answer whether a third drug is necessary or whether taking two drugs can increase tolerability without a substantial loss of efficacy.

    San Francisco, California and other locations

  • ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

    Sorry, in progress, not accepting new patients

    The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

    San Francisco, California and other locations

Our lead scientists for Nontuberculous Mycobacteria research studies include .

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