Clinical trials: Nontuberculous Mycobacterial Infection
Mycobacterium Avium-intracellulare Infection, HIV Infections
A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS
This study is designed to evaluate the efficacy and safety of clarithromycin given orally at 1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients with AIDS.
- Trial name
- NCT00000644
- Testing
- Clarithromycin
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Mycobacterium Ulcerans Disease, Buruli Ulcer
Timing of Surgical Intervention in Buruli Ulcer Patients Treated With Antibiotics
SUMMARY Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic in West Africa. It often leads to functional limitations.
- Trial name
- Burulitime (NCT01432925)
- Testing
- surgical intervention on Buruli ulcer
- Where
- 2 sites in Benin
- Volunteers
- 119 people
- Sponsor
- University Medical Center Groningen
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
Buruli Ulcer, Mycobacterium Ulcerans
BURULICO Drug Trial Study Protocol: RCT SR8/SR4+CR4, GHANA
The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery.
- Trial name
- BURULICO (NCT00321178)
- Testing
- SR4 - switch to CR4
- Where
- 2 sites in Ghana
- Volunteers
- 151 people
- Sponsor
- University Medical Center Groningen
Mycobacterium Infections
Study of Mycobacterial Infections
This study will examine the symptoms, course of disease and treatment of non-tuberculous mycobacterial (NTM) infections, as well as the genetics involved in these infections.
- Trial name
- NCT00018044
- Testing
- Clofazimine
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Leprosy, Buruli Ulcer
Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia
Appropriate targeting of interventions for neglected tropical diseases (NTDs) that require innovative and intensified disease management (IDM) requires accurate data on the distribution of these diseases within endemic countries.
- Conditions
- Leprosy, Buruli Ulcer, Yaws, Lymphatic Filariases
- Trial name
- NCT03683745
- Where
- Liberia
- Volunteers
- 56,285 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Leprosy
Leprosy Skin Test Antigens Phase 1
This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae.
- Trial name
- NCT01920750
- Testing
- MLCwA, MLSA-LAM, Mock Antigen
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation
Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
The goal of this observational study is to support U.S. healthcare centers in determining if they may have an NTM outbreak among patients receiving care at the healthcare center.
- Conditions
- Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation, Healthcare Associated Infection, Mycobacterium Infections
- Trial name
- TrANsMIt (NCT06155747)
- Testing
- Epidemiologic investigation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of North Carolina, Chapel Hill
Mycobacterium Abscessus Infection
Epetraborole in Patients With Mycobacterium Abscessus Lung Disease
This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus…
- Trial name
- REBOUND (NCT07301320)
- Testing
- Epetraborole
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Kevin Winthrop
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.
Nontuberculous Mycobacterial Pulmonary Infection
PK and PD of Antibiotics for Treatment of Mycobacterium Abscessus Pulmonary Disease
Investigating the PK and PD indices in patients with M. abscessus complex-PD who will be treated with a currently recommended regimen, minimum inhibitory concentrations of organism, and their relation with clinical outcomes
- Trial name
- NCT05676138
- Testing
- Measuring PK and PD indices in patients who receive conventional treatment
- Volunteers
- 40 people
- Sponsor
- Seoul National University Hospital
Mycobacterium Avium Intracellulare Complex (MAC)
Mycobacterium Avium Intracellulare Complex (MAC) Study
This study is short course (3 month) multiple drug antibiotic therapy. The purpose of this research study is to evaluate the clinical and radiology response to assess whether drug resistance develops and assess quality of life…
- Trial name
- MAC (NCT00826423)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Mayo Clinic
Allergic Cutaneous Vasculitis, Urticaria
Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome
This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence of dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients.
- Conditions
- Allergic Cutaneous Vasculitis, Urticaria, Psoriasis, Acne
- Trial name
- NCT02550080
- Testing
- Dapsone, HLA-B*1301
- Where
- China
- Volunteers
- 3,130 people
- Sponsor
- Shandong Provincial Institute of Dermatology and Venereology
Healthy, Mycobacterium Infections, Atypical
Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections.
- Trial name
- NCT00001318
- Testing
- interferon gamma
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Mycobacterium Abscessus Infection, Bacteriophage Therapy
Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection
The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant…
- Conditions
- Mycobacterium Abscessus Infection, Bacteriophage Therapy, Pulmonary Disease
- Trial name
- NCT07429162
- Testing
- DP-QB-MYA-002
- Volunteers
- 1 people
- Sponsor
- Alberta Health services
Immune Modulation, Tuberculosis
CD8 Reactivity to Microorganisms in Blood and Breast Milk
Background: When a person is exposed to something that causes an infection, the body sends a type of cell called CD8 T cells to attack it. Those cells are also found in breast milk.
- Conditions
- Immune Modulation, Tuberculosis, Leprosy, Pertussis
- Trial name
- NCT03084614
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Mycobacterium Avium-intracellulare Infection, HIV Infections
A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
This study is designed to find out whether HIV-positive patients whose immune systems have improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium avium complex (MAC) disease.
- Trial name
- NCT00000947
- Testing
- Azithromycin
- Where
- 19 sites in United States
- Volunteers
- 850 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cystic Fibrosis
Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus
To evaluate the change in M. abscessus cfu/g in induced sputum samples from baseline to the end of treatment with RESP301 in patients with cystic fibrosis who have treatment-naïve or treatment-refractory M.
- Trial name
- NOMAB (NCT05101915)
- Testing
- RESP301
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Papworth Hospital NHS Foundation Trust
Nontuberculous Mycobacteria
The Italian REgistry of Pulmonary Non-tuberculous mycobactEria
The Italian registry of pulmonary non-tuberculous mycobacteria (NTM) -IRENE- is an observational, multicenter, prospective, cohort study enrolling consecutive adult patients with either a NTM respiratory infection or…
- Trial name
- IRENE (NCT03339063)
- Where
- 26 sites in Italy
- Volunteers
- 500 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico