Clinical trials: Nontuberculous Mycobacteria
Mycobacterium Avium-intracellulare Infection, HIV Infections
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200…
- Trial name
- NCT00002032
- Testing
- Rifabutin
- Where
- 33 sites in United States
- Volunteers
- 750 people
- Sponsor
- Pharmacia
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
Cartilage Diseases
Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC
Retrospective, multicenter, single arm, non-interventional study to assess the safety and Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients treated for cartilage defects in the knee.
- Trial name
- NBasic (NCT03808623)
- Testing
- MAC with NOVOCART Basic
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 41 people
- Sponsor
- Tetec AG
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
Nontuberculous Mycobacterium Infection, Mycobacterium Abscessus Infection
Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex
The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease
- Trial name
- NCT06004037
- Testing
- Delpazolid
- Where
- 5 sites in South Korea
- Volunteers
- 24 people
- Sponsor
- LigaChem Biosciences, 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
Mycobacterium Infections, Nontuberculous
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
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…
- Trial name
- ENCORE (NCT04677569)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 258 sites in United States, Argentina and 21 more
- Volunteers
- 425 people
- Sponsor
- Insmed Incorporated
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.
Leprosy, Multibacillary
A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy
The purpose of this study is to assess the efficacy of an 8-week bedaquiline monotherapy regimen in participants with treatment-naive, multibacillary (MB) leprosy.
- Trial name
- NCT03384641
- Testing
- Bedaquiline 200 mg
- Where
- 2 sites in Brazil
- Volunteers
- 11 people
- Sponsor
- Janssen Research & Development, LLC
Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2.
- Trial name
- NCT05496374
- Testing
- SPR720 500 mg, SPR720 1000 mg
- Where
- 28 sites in United States
- Volunteers
- 25 people
- Sponsor
- Spero Therapeutics
Mycobacterium Avium-Intracellulare Infection, HIV Infections
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia…
- Trial name
- NCT00002101
- Testing
- Ethambutol hydrochloride, Clarithromycin, Rifabutin
- Where
- 44 sites in United States
- Volunteers
- 450 people
- Sponsor
- Pharmacia
Mycobacterium Avium-Intracellulare Infection, HIV Infections
A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
To evaluate the efficacy and safety of azithromycin administered once a week in the prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised HIV-infected patients with a CD4 count < 100 cells/mm3.
- Trial name
- NCT00002309
- Testing
- Azithromycin
- Where
- 3 sites in United States
- Sponsor
- Pfizer
Mycobacterium Avium-intracellulare Infection, HIV Infections
A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an…
- Trial name
- NCT00002140
- Testing
- Ethambutol hydrochloride, Clarithromycin, Azithromycin
- Where
- 24 sites in United States
- Sponsor
- Pfizer
Mycobacterium Avium-Intracellulare Infection, HIV Infections
An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy
To evaluate the efficacy and safety of azithromycin given chronically for the treatment of Mycobacterium avium (MAC) bacteremia in patients failing or intolerant of current available MAC therapy.
- Trial name
- NCT00002089
- Testing
- Azithromycin
- Where
- United States
- Sponsor
- Pfizer
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.
Solid Tumour, Adenocarcinoma of the Colorectal
Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors
This is a two-part, Phase 1 open label, multi-center, dose escalation study of CEP-37250/KHK2804 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is…
- Conditions
- Solid Tumour, Adenocarcinoma of the Colorectal, Adenocarcinoma of the Pancreas
- Trial name
- NCT01447732
- Testing
- CEP-37250/KHK2804
- Volunteers
- 71 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Mycobacterium Abscessus Infection
Inhaled Nitric Oxide for Patients With MABSC
A Prospective, Open labeled, multi-Center, Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently via Inhalation to Subjects with NTM (specifically MABSC) Nitric Oxide (NO) has been shown to play…
- Trial name
- NCT03208764
- Testing
- Nitric Oxide
- Where
- Israel
- Volunteers
- 9 people
- Sponsor
- Beyond Air Inc.
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
Mycobacterium Avium-Intracellulare Infection, HIV Infections
An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)
To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.
- Trial name
- NCT00002090
- Testing
- Azithromycin
- Where
- 6 sites in United States
- Sponsor
- Pfizer
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.