Clinical trials: Mycobacterium Infection
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
Tuberculosis
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
- Trial name
- NCT02253537
- Testing
- CST001
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Tuberculosis, Pulmonary Tuberculosis
StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard tuberculosis (TB) treatment regimen in adults with TB.
- Trial name
- NCT03882177
- Testing
- Pravastatin, Rifafour, Vitamin B6
- Where
- South Africa
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infections and Infestations, Pulmonary Tuberculosis
PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)
This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose…
- Trial name
- DECODE (NCT04550832)
- Testing
- Delpazolid, Bedaquiline, Delamanid, Moxifloxacin
- Where
- 5 sites in South Africa, Tanzania
- Volunteers
- 76 people
- Sponsor
- LigaChem Biosciences, Inc.
Tuberculosis, HIV/AIDS
Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)
The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected persons (200 drinkers and 100 non-drinkers)…
- Conditions
- Tuberculosis, HIV/AIDS, Alcohol Abuse
- Trial name
- ADEPTT (NCT03302299)
- Testing
- Isoniazid 300 Mg ORAL TABLET, Pyridoxine 25 Mg Oral Tablet
- Where
- Uganda
- Volunteers
- 302 people
- Sponsor
- University of California, San Francisco
Bladder Cancer
MK-3475/BCG in High Risk Superficial Bladder Cancer
This is a single center Phase I safety and efficacy study of MK-3475 therapy used in combination with bladder infused BCG treatment for patients, 18 years or older, with high risk superficial bladder cancer (cancer not yet…
- Trial name
- MARC (NCT02324582)
- Testing
- Intravenous MK-3475/ Intravesical BCG
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Southern Illinois University
HIV Infections, Tuberculosis
Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa
The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa.
- Trial name
- NCT00096681
- Volunteers
- 762 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
Tuberculosis
Xpert MTB/Rif, a New Tool for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil
Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases.
- Trial name
- NCT01363765
- Testing
- Xpert MTB/Rif, Smear microscopy
- Where
- Brazil
- Volunteers
- 34,758 people
- Sponsor
- Ataulpho de Paiva Foundation
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
Pretomanid is being used in an antimicrobial combination regimen(s) to treat patients with pulmonary tuberculosis (TB). The primary purpose of the Male Reproductive Safety - "BPaMZ/SEM"- clinical study is to evaluate the…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- PaSEM (NCT04179500)
- Testing
- Pretomanid, Bedaquiline, moxifloxacin
- Where
- 4 sites in Georgia, South Africa
- Volunteers
- 26 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Tuberculosis, Pulmonary
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults
Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.
- Trial name
- NCT03758612
- Testing
- TBI-223 oral suspension, TBI-223 enteric capsule, TBI-223 SR Tablet Prototype 1
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Latent Tuberculosis Bacteriology and Histology Unknown, Latent Tuberculosis
A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease.
- Trial name
- NCT01865487
- Testing
- H56ug/IC31nmol
- Where
- 2 sites in South Africa
- Volunteers
- 98 people
- Sponsor
- Aeras
Tuberculosis, Pulmonary
Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design
This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized, controlled clinical trial that will compare the efficacy and safety of four experimental four drug regimens with a standard control regimen in…
- Trial name
- NCT01785186
- Testing
- SQ109, Rifampicin, Moxifloxacin
- Where
- 7 sites in South Africa, Tanzania
- Volunteers
- 365 people
- Sponsor
- Michael Hoelscher
Cystic Fibrosis
Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of nontuberculous mycobacterial (NTM) lung disease.
- Trial name
- NCT02372383
- Testing
- Ethambutol, Rifampin, Azithromycin
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Tuberculosis
High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)
Isoniazid (INH) is a drug commonly used to treat tuberculosis (TB) worldwide. Sometimes, the bacteria that cause TB can become resistant to INH.
- Trial name
- NCT01936831
- Testing
- Isoniazid, Vitamin B6
- Where
- 2 sites in Haiti, South Africa
- Volunteers
- 282 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
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
An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Tuberculosis remains a concerning health problem, with Mycobacterium Tuberculosis (MTB) now causing more deaths than acquired immune deficiency syndrome (AIDS).
- Trial name
- NCT03557281
- Testing
- GSK3036656, Rifafour e-275
- Where
- South Africa
- Volunteers
- 76 people
- Sponsor
- GlaxoSmithKline
Pulmonary Tuberculosis
Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis
The purpose of this study is to assess the safety, early bactericidal activity (EBA) and pharmacokinetics of TBA-7371 in adult participants with rifampicin-sensitive tuberculosis and select dose regimen(s) for future studies.
- Trial name
- NCT04176250
- Testing
- TBA-7371, HRZE
- Where
- 4 sites in South Africa
- Volunteers
- 93 people
- Sponsor
- Gates Medical Research Institute
Tuberculosis, Multidrug-Resistant
Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB
Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around the world. This type of tuberculosis is very difficult to treat, and many patients die from it.
- Trial name
- Opti-Q (NCT01918397)
- Testing
- Levofloxacin, Optimized background regimen (OBR)
- Where
- 3 sites in Peru, South Africa
- Volunteers
- 111 people
- Sponsor
- Boston University
Peripheral Solitary Pulmonary Nodule or Tuberculoma
Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients
The aim of this study is to study the safety and effectiveness of the effects on the perioperative pain control comparing between the thoracic paravertebral nerve block using the camera guided and the intrathoracic intercostals…
- Trial name
- NCT03086213
- Testing
- Propofol, Sulfentanyl, Dexmedetomidine
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Shenzhen Third People's Hospital
Tuberculosis, Multi-Drug Resistant Tuberculosis
Metronidazole for Pulmonary Tuberculosis (South Korea)
This study will evaluate the effect of adding metronidazole to standard second-line therapy for tuberculosis in patients who have multi-drug resistant tuberculosis (MDR-TB) of the lungs.
- Trial name
- NCT00425113
- Testing
- Metronidazole, Blood Draw, CT Scan
- Where
- 2 sites in South Korea
- Volunteers
- 35 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)