Clinical trials: Nontuberculous Mycobacterium Infection
HIV Infection, HIV-1 Infection
A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and…
- Conditions
- HIV Infection, HIV-1 Infection, Mycobacterium Avium Complex (MAC)
- Trial name
- RIFAMARA (NCT01894776)
- Testing
- Rifabutin, Maraviroc
- Where
- Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
- Trial name
- NCT04553406
- Testing
- SPR720, Open-label Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- Spero Therapeutics
Mycobacterium Infections, Nontuberculous
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary…
- Trial name
- OPTIMA (NCT03421743)
- Testing
- Inhaled molgramostim, Antimycobacterial regimen
- Where
- 5 sites in Australia, United Kingdom
- Volunteers
- 32 people
- Sponsor
- Savara Inc.
Obesity, Leprosy
Effect of Weight and/or Obesity on Dapsone Drug Concentrations
This study will find how weight affects the dosing of a drug called dapsone. Currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.
- Conditions
- Obesity, Leprosy, Tuberculosis
- Trial name
- NCT01165840
- Testing
- Dapsone
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Texas Tech University Health Sciences Center
Mycobacterium Infections, Nontuberculous
Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease.
- Trial name
- NCT01315236
- Testing
- Liposomal amikacin for inhalation (LAI)
- Where
- 19 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Insmed Incorporated
Leprosy
Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
This is a cluster randomized trial on effectiveness of different modalities of Single Double Dose of Rifampicin Post-Exposure Prophylaxis (SDDR-PEP) for leprosy in the Comoros (Anjouan and Mohéli) and Madagascar.
- Trial name
- PEOPLE (NCT03662022)
- Testing
- Rifampicin
- Where
- 3 sites in Comoros, Madagascar
- Volunteers
- 144,000 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Mycobacterium Infections, Nontuberculous, Cystic Fibrosis (CF)
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing…
- Trial name
- ENCORE (NCT03597347)
- Testing
- Molgramostim nebulizer solution, PARI eFlow nebulizer system
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Savara Inc.
Mycobacterium Infections, Nontuberculous
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg administered once daily (QD) when added to multi-drug regimen (MDR) in participants with Nontuberculous Mycobacterial (NTM) lung infection…
- Trial name
- CONVERT (NCT02344004)
- Testing
- LAI (Liposomal Amikacin for Inhalation) 590 mg
- Volunteers
- 336 people
- Sponsor
- Insmed Incorporated
Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by…
- Conditions
- Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection
- Trial name
- NCT04922554
- Testing
- Omadacycline Oral Tablet
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- Paratek Pharmaceuticals Inc
Mycobacterium Infections, Atypical
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
- Trial name
- NCT01097005
- Where
- 59 sites in Japan
- Volunteers
- 466 people
- Sponsor
- Mylan Inc.
Multiple Sclerosis, Relapsing Forms
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).
- Trial name
- NCT01585766
- Testing
- MEDI-551 30 MG-IV, MEDI-551 60 MG-SC, MEDI-551 100 MG-IV
- Where
- 16 sites in United States, Poland and 2 more
- Volunteers
- 56 people
- Sponsor
- MedImmune LLC
NTM Lung Infection Due to MAC
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
This is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous…
- Trial name
- NCT02628600
- Testing
- LAI 590 mg, Multi-drug regimen
- Volunteers
- 163 people
- Sponsor
- Insmed Incorporated
Nontuberculous Mycobacterium Infection
A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial Infection
The purpose of this study is to evaluate the efficacy and safety of open-label exposure of gNO in patients with NTM lung disease. Subjects will receive the study drug by inhaling through a nasal mask.
- Trial name
- NCT03748992
- Testing
- gNO
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Medical University of South Carolina
MAC Lung Disease, Treatment Refractory MAC Lung Disease
Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
This is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease.
- Trial name
- NCT05327803
- Testing
- Epetraborole
- Where
- 91 sites in United States, Australia and 2 more
- Volunteers
- 177 people
- Sponsor
- AN2 Therapeutics, Inc
Mycobacterium Infections, Nontuberculous
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the…
- Trial name
- ARISE (NCT04677543)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 99 people
- Sponsor
- Insmed Incorporated
Renal Cell Carcinoma (RCC)
Study of Safety and Functional Imaging of cG250 and Sunitinib in Patients With Advanced Renal Cell Carcinoma
This clinical trial explores the safety, efficacy, and effects on functional imaging of cG250 monoclonal antibody (mAb) administered intravenously weekly in combination with daily oral sunitinib, in patients with advanced renal…
- Trial name
- NCT00520533
- Testing
- Chimeric monoclonal antibody cG250, Sunitinib malate
- Where
- Australia
- Volunteers
- 8 people
- Sponsor
- Ludwig Institute for Cancer Research
Leprosy
Leprosy Skin Test Antigens Trial
The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to…
- Trial name
- NCT00128193
- Testing
- Tuberculin, Purified Protein Derivative, MLSA-LAM, MLCwA
- Where
- 6 sites in United States, Nepal
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cystic Fibrosis
Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of nontuberculous mycobacterial (NTM) lung disease.
- Trial name
- NCT02372383
- Testing
- Ethambutol, Rifampin, Azithromycin
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Leprosy
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2)
This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022.
- Trial name
- BE-PEOPLE P2 (NCT05406479)
- Testing
- BE-PEP (Bedaquiline), SDR-PEP, BE-PEP (Rifampicine)
- Where
- Comoros
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Mycobacterium Avium Complex
A Study of Standard Drugs for Mycobacterium Avium Complex
To assess the early bactericidal activity of Azithromycin 250mg by mouth daily over the first 14 days of treatment for Mycobacterium avium complex (MAC) lung disease.
- Trial name
- NCT04287049
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University