Clinical trials: Tuberculosis Infection
Tuberculosis, Pulmonary Tuberculosis
Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
The METHOD study will examine whether adding metformin to standard antibiotic treatment for tuberculosis (TB) in people with HIV is safe and well tolerated.
- Conditions
- Tuberculosis, Pulmonary Tuberculosis, HIV Coinfection
- Trial name
- METHOD (NCT04930744)
- Testing
- Isoniazid, Rifampicin, Ethambutol
- Where
- 2 sites in South Africa
- Volunteers
- 112 people
- Sponsor
- University of Massachusetts, Worcester
Pediatric HIV Infection, Tuberculosis Infection
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children.
- Trial name
- NCT05069688
- Testing
- rifampicin
- Where
- Nigeria
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Tuberculosis, HIV I Infection
ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
This study will compare community-delivered, multi-month dispensing of tuberculosis preventive therapy (TPT) to standard-of-care clinic-based TPT delivery in a population of South African adults who are recommended to receive TB…
- Trial name
- ThiPhiSA (NCT06214910)
- Testing
- Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP), Clinic-link TPT
- Where
- South Africa
- Volunteers
- 301 people
- Sponsor
- University of Washington
Pediatric HIV Infection, Latent Tuberculosis
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children.
- Trial name
- NCT06281834
- Testing
- Rifapentine, Dolutegravir
- Where
- Nigeria
- Volunteers
- 25 people
- Sponsor
- Brigham and Women's Hospital
Tuberculosis, Tuberculosis, Pulmonary
Shortened Regimen for Drug-susceptible TB in Children
While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node, Mycobacterium Tuberculosis
- Trial name
- SMILE-TB (NCT06253715)
- Testing
- Isoniazid, Rifampin, Pyrazinamide
- Where
- 9 sites in India, Indonesia and 5 more
- Volunteers
- 860 people
- Sponsor
- Johns Hopkins University
Tuberculosis Infection, Latent, Tuberculosis Active
SCAF-TB - Saving Children and Their Families From Tuberculosis: Implementation Research to Improve TB Preventive Treatment Initiation and Completion Rates Among Contact Persons in Tajikistan and Tanzania
The SCAF-TB study aims to evaluate how the WHO-endorsed SIILTIBCY skin test can be best implemented to test close contacts for tuberculosis infection (TBI) in Tajikistan and Tanzania, either facility-based or home-based delivered…
- Conditions
- Tuberculosis Infection, Latent, Tuberculosis Active, TPT
- Trial name
- SCAF-TB (NCT07714707)
- Testing
- CY-TB Patch, Audiblehealth DX
- Where
- 2 sites in Tajikistan, Tanzania
- Volunteers
- 880 people, healthy volunteers welcome
- Sponsor
- KNCV Tuberculosis Foundation
Latent Tuberculosis, Staphylococcus Aureus
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
Two commonly used treatments for latent tuberculosis infection are either 4 months rifampicin or 6-9 months isoniazid. The invistigators will study the risk of acquisition of rifampicin resistance in commensal Staphylococcus…
- Trial name
- NCT05073926
- Testing
- No intervention is part of the study protocol
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Region Skane
Tuberculosis, Tuberculosis Infection
Testing Health Workers At Risk to Advance Our Understanding of TB Infection
It has been estimated that 1.7 billion people have tuberculosis (TB) infection; yet current tests are unable to predict which people are at highest risk of developing TB disease, which can be life-threatening.
- Trial name
- THWART-TB (NCT06221488)
- Testing
- TB infection testing
- Where
- South Africa
- Volunteers
- 300 people
- Sponsor
- Beth Israel Deaconess Medical Center
Tuberculosis, Tuberculosis (TB)
Shaping a Community-based Pathway to Improve TB Surveillance Among African and Hindustan Immigrants Experiencing Vulnerabilities
This two-phase, mixed-methods approach project aims to develop a community-based, participatory, and co-created TB/TB infection (TBI) screening care pathway for African and Hindustan immigrants, who often face socioeconomic…
- Conditions
- Tuberculosis, Tuberculosis (TB), Tuberculosis Active, Tuberculosis Infection, Latent
- Trial name
- AFROHINDU-MIGT (NCT07687121)
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Universidade Nova de Lisboa
Tuberculosis, HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant…
- Trial name
- NCT03141060
- Testing
- Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB
- Where
- 5 sites in India, South Africa and 1 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Tuberculosis Infection, Latent
Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan
RIFA-REAL is a prospective observational longitudinal study evaluating the safety, feasibility, and effectiveness of rifapentine-based shorter treatment regimens for drug-susceptible tuberculosis (DS-TB) and tuberculosis…
- Conditions
- Tuberculosis, Tuberculosis Infection, Latent, Tuberculosis, Pulmonary, Drug Sensitive
- Trial name
- RIFA-REAL (NCT07668479)
- Volunteers
- 350 people
- Sponsor
- Public Union "Kazakhstan Association of Phthisiopulmonologists"
Tuberculosis Infection, Isoniazid Adverse Reaction
Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.
- Trial name
- NCT05413551
- Testing
- Low-dose isoniazid, Standard dose of isoniazid, High-dose isoniazid
- Where
- Brazil
- Volunteers
- 78 people
- Sponsor
- Stanford University
Tuberculosis, TB Infection
A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia
- Trial name
- NCT07647107
- Testing
- LipovaxinS4-EAH (Middle Dose), LipovaksinS4-EAH (High Dose)
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Latent Tuberculosis Infection (LTBI)
C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia
This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
- Trial name
- C-TST (NCT07587164)
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
- Where
- Indonesia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis, Pulmonary, Tuberculosis, MDR
Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
The purpose of this study is to assess the efficacy and safety of 2 repurposed drugs (acetylsalicylic acid and ibuprofen), for use as adjunct therapy added to, and compared with, the standard of care (SoC) WHO-recommended TB…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, MDR, Tuberculosis Infection
- Trial name
- SMA-TB (NCT04575519)
- Testing
- Control group, ASA group, IBU group
- Where
- 3 sites in Georgia, South Africa
- Volunteers
- 426 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
Multi Drug Resistant Tuberculosis, HIV Infections
An Adaptive Randomized Controlled Trial
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment…
- Trial name
- ADAP-TIV (NCT05633056)
- Testing
- Adherence support intevention
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Tuberculosis, HIV Infections
Study of Limited Versus Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana.
- Trial name
- NCT00164281
- Testing
- Isoniazid
- Where
- Botswana
- Volunteers
- 1,995 people
- Sponsor
- Centers for Disease Control and Prevention
Healthy, Latent Tuberculosis Infection (LTBI)
Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung
Background: Tuberculosis (TB) is a lung disease. It is caused by inhaling a type of airborne bacterium. Tuberculin Purified Protein Derivative (PPD) is used to test for TB exposure. It is usually injected under a person s skin.
- Trial name
- NCT05027958
- Testing
- Tuberculin Purified Protein Derivative
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Tuberculosis, HIV Coinfection
Closing -TB GAPs - for People Living With HIV: TB Guidance for Adaptable Patient-Centered Service
Tuberculosis (TB) is the world's leading infectious cause of mortality and responsible for 1/3 of deaths in people living with human immunodeficiency virus (PLHIV).
- Conditions
- Tuberculosis, HIV Coinfection, Tuberculosis Infection
- Trial name
- TB_GAPS (NCT05342064)
- Testing
- patient-centered TB preventive therapy, TB preventive therapy adherence support
- Where
- 5 sites in Eswatini, Lesotho and 3 more
- Volunteers
- 6,500 people
- Sponsor
- Baylor College of Medicine
Tuberculosis Infection, Latent
Shorter and Safer Treatment Regimens for Latent TB
Our study rationale is based on: 1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe; 2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are superior with respect to…
- Trial name
- SSTARLET (NCT06498414)
- Testing
- rifampin standard arm, rifampin double dose, levofloxacin and rifapentine
- Where
- 14 sites in Benin, Brazil and 3 more
- Volunteers
- 1,800 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre