Clinical trials: Nontuberculous Mycobacteria
Mycoses, Mycobacterium Avium-Intracellulare Infection
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients.
- Conditions
- Mycoses, Mycobacterium Avium-Intracellulare Infection, HIV Infections
- Trial name
- NCT00002122
- Testing
- Azithromycin, Rifabutin, Fluconazole
- Where
- 12 sites in United States
- Volunteers
- 720 people
- 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
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
Mycobacterium Infections, Nontuberculous
Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease
A prospective, single-center, single-blinded study involving patients with refractory nontuberculous mycobacteria lung disease to ascertain pharmacokinetics, safety, efficacy, and tolerability of two dose levels of parenteral…
- Trial name
- IMPULSE-7 (NCT04154826)
- Testing
- Recombinant human interleukin-7
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Revimmune
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
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, 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.
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 Avium-Intracellulare Infection, HIV Infections
Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.
To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia.
- Trial name
- NCT00002192
- Testing
- Rifapentine, Ethambutol hydrochloride, Clarithromycin
- Where
- United States
- Sponsor
- Anderson Clinical Research
Systemic Lupus Erythematosus
A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while…
- Trial name
- NCT07630714
- Testing
- Anifrolumab + APFS
- Where
- 39 sites in Australia, Belgium and 8 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
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 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
Lung Diseases, Pulmonary Disease
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects…
- Conditions
- Lung Diseases, Pulmonary Disease, Cystic Fibrosis, Cystic Fibrosis Lung
- Trial name
- NCT03309358
- Testing
- Inhaled SNSP113
- Where
- 2 sites in United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Synspira, Inc.
Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis, Mycobacterial Pneumonia, Mycobacterium Abscessus Infection
- Trial name
- NCT04685720
- Testing
- LungFit
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Beyond Air Inc.
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
Lung Infection
Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72…
- Trial name
- NCT00043355
- Testing
- interferon gamma-1b
- Volunteers
- 100 people
- Sponsor
- InterMune
Mycobacterium Avium-Intracellulare Infection, HIV Infections
A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy
To evaluate the efficacy and safety of azithromycin given chronically for the treatment of serious nontuberculous mycobacterial infection in patients failing or intolerant of other available therapy.
- Conditions
- Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection
- Trial name
- NCT00002085
- Testing
- Azithromycin
- Where
- 2 sites in United States
- Sponsor
- Pfizer
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 objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4…
- Trial name
- NCT00002267
- Testing
- Rifabutin
- Where
- 43 sites in United States, Canada
- Volunteers
- 750 people
- Sponsor
- Pharmacia
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.