Clinical trials: Mycobacterial Disease
Tuberculosis
Development of a Clinical-epidemiological Score Predictive of Tuberculosis.
Despite being a curable and preventable disease, tuberculosis still represents a major global health problem. It is estimated that 10.8 million people contracted tuberculosis in 2023, with an incidence of 134 per 100,000…
- Trial name
- SCORE-TB (NCT07485868)
- Testing
- Development and validation of a clinical-epidemiological predictive score for the diagnosis of pulmonary tuberculosis
- Volunteers
- 686 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Non-Tuberculous Mycobacterial Pneumonia
Nutritional Assessment in Non-tuberculous Mycobacteria Pulmonary Disease
Non-tuberculous mycobacterial (NTM) pulmonary disease (PD) is an emerging condition with heterogeneous manifestations from both the microbiological and the clinical point of view.
- Trial name
- nutriNTM (NCT05376280)
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- University of Milano Bicocca
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
Tuberculosis, Tuberculosis, Pulmonary
Point-of-care Triage Test for Active Tuberculosis
Background: Tuberculosis (TB) is a bacterial lung infection leaving 3.6 million people undiagnosed each year. Thirty percent of infected people do not receive treatment due to failure to receive diagnostic testing or being lost…
- Trial name
- TriageTB (NCT04232618)
- Testing
- Multi-biomarker point-of-care test
- Where
- South Africa
- Volunteers
- 900 people
- Sponsor
- University of Stellenbosch
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
Lung Diseases, Tuberculosis
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
This study will determine the differential cumulative mean number of isoniazid (INH) pills completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1) peer adherence coaching, parent training…
- Trial name
- NCT00233168
- Testing
- Adherence Program, Life Skills and Self-Esteem Training Program (Attention Control Arm)
- Where
- United States
- Volunteers
- 263 people
- Sponsor
- San Diego State University
Tuberculosis, Latent Tuberculosis
The Epidemiology of TST Change in Korea
TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.
- Trial name
- NCT01850043
- Where
- South Korea
- Volunteers
- 5,552 people, healthy volunteers welcome
- Sponsor
- Asan Medical Center
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
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
Tuberculosis, Hiv
Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB
Stage 1 proposed study will provide evidence to support the use of twice-daily dose 50mg DTG in children (20-35kgs) co-treated with RIF.
- Trial name
- ORCHID (NCT04746547)
- Testing
- Dolutegravir 50 MG, Dolutegravir 10 MG
- Where
- South Africa
- Volunteers
- 20 people
- Sponsor
- University of KwaZulu
Pulmonary Tuberculosis
AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT
Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of…
- Trial name
- AIPH-TB-RCT-P2 (NCT07467252)
- Testing
- Pyrazinamide and Hydroxychloroquine (AI-Optimised), Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)
- Where
- Saudi Arabia
- Volunteers
- 200 people
- Sponsor
- Ministry of Health, Saudi Arabia
Tuberculosis, HIV Infections
Tuberculosis in HIV Infected Patients in Uganda
This was a clinical trial in HIV infected patients with tuberculosis. The study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral…
- Trial name
- NCT00057421
- Testing
- prednisolone
- Where
- Uganda
- Volunteers
- 190 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Non-Tuberculous Mycobacterial Pneumonia
A Retrospective Study Investigating the Factors Related to Non-tuberculous Mycobacterial Pulmonary Disease in Hong Kong
In this retrospective study, we aim to investigate the demographic and clinical features of patients with nontuberculous mycobacteria (NTM) lung disease in our hospital and the trends and diversity of NTM species isolated in the…
- Trial name
- NCT04538898
- Where
- Hong Kong
- Volunteers
- 200 people
- Sponsor
- Chinese University of Hong Kong
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)
Recurrent Tuberculosis
Improving Retreatment Success (IMPRESS)
This is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary TB, among patients previously treated for TB.
- Trial name
- IMPRESS (NCT02114684)
- Testing
- moxifloxacin
- Where
- South Africa
- Volunteers
- 197 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Pulmonary Tuberculosis
Effect of Vitamin D and Zinc Supplementation on Inflammatory Biomarkers in Pulmonary Tuberculosis Patients
This study evaluates the effect of combined Vitamin D and Zinc supplementation on inflammatory biomarkers in pulmonary tuberculosis (TB) patients during the intensive phase of treatment.
- Trial name
- NCT07899138
- Testing
- Vitamin D (Cholecalciferol ), Zinc (zinc sulphate)
- Where
- Indonesia
- Volunteers
- 32 people
- Sponsor
- Hasanuddin University
Tuberculosis Infection, Tuberculosis Prevention
Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial
This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts…
- Trial name
- NCT04494516
- Where
- 2 sites in Ethiopia, South Africa
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Infections, Tuberculosis
The Treatment of Tuberculosis in HIV-Infected Patients
PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in…
- Trial name
- NCT00001033
- Testing
- Ethambutol hydrochloride, Isoniazid, Pyrazinamide
- Where
- 12 sites in United States
- Volunteers
- 650 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years.
- Trial name
- NCT07762014
- Testing
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Where
- Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Biothervax SpA
Tuberculosis, Bone
Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis
Contezolid is a novel oxazolidinone antibacterial agent that has shown promising application prospects in the field of tuberculosis treatment in recent years.
- Conditions
- Tuberculosis, Bone, Joint
- Trial name
- NCT06811012
- Testing
- Contezolid, Linezolid (LZD)
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Beijing Chest Hospital