Clinical trials: Multidrug-Resistant Bacterial Infections
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
Training Protocol on the Natural History of Tuberculosis
Background: Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.
- Conditions
- Mycobacterium Infections, Tuberculosis, Multidrug-Resistant, Latent Tuberculosis, Tuberculosis
- Trial name
- NCT01212003
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with…
- Conditions
- Tuberculosis, Multidrug Resistant Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
- Trial name
- NCT07170800
- Testing
- JDB0131 100mg, JDB0131 200mg, Delamanid (D)
- Where
- 7 sites in China
- Volunteers
- 60 people
- Sponsor
- WestVac Biopharma Co., Ltd.
Pulmonary Tuberculosis
A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture…
- Trial name
- NCT02333799
- Testing
- Bedaquiline, PA-824, Linezolid
- Where
- 3 sites in South Africa
- Volunteers
- 109 people
- Sponsor
- Global Alliance for TB Drug Development
Multi-antibiotic Resistance
Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient
The goal of this observational study is to evaluate the screening for multidrug resistant bacteria in patients admitted to hospitals in Scania.
- Trial name
- NCT06370299
- Testing
- (exposure of) MDR carriage
- Volunteers
- 10,000 people
- Sponsor
- Region Skane
Tuberculosis, Multidrug-Resistant, Infection, Bacterial
Evaluating Newly Approved Drugs for Multidrug-resistant TB
endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).
- Conditions
- Tuberculosis, Multidrug-Resistant, Infection, Bacterial, Pulmonary Tuberculoses
- Trial name
- endTB (NCT02754765)
- Testing
- Bedaquiline, Delamanid, Clofazimine
- Where
- 12 sites in Georgia, India and 5 more
- Volunteers
- 754 people
- Sponsor
- Médecins Sans Frontières, France
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)
HIV Infections, Tuberculosis
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.
To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB).
- Trial name
- NCT00000796
- Testing
- Cycloserine, Ethionamide, Capreomycin sulfate
- Where
- 21 sites in United States
- Volunteers
- 525 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Rifampicin-Resistant Tuberculosis
A 6-Month MDR-END Plus Regimen for Rifampicin-Resistant Tuberculosis
This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa.
- Trial name
- MDR-ENDPlus (NCT07675954)
- Testing
- MDR-END Plus regimen, Standard-of-care (SoC) treatment
- Where
- 2 sites in South Africa
- Volunteers
- 294 people
- Sponsor
- Seoul National University Hospital
Multi-drug Resistant Tuberculosis
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
PandrTB is a study of the pharmacokinetics(PK) and pharmacodynamics(PD) of bedaquiline, delamanid, clofazimine, linezolid, moxifloxacin, levofloxacin and pyrazinamide used in novel combinations to treat multidrug-resistant…
- Trial name
- PandrTB (NCT03827811)
- Where
- 7 sites in Kazakhstan, Lesotho and 4 more
- Volunteers
- 625 people
- Sponsor
- University of Cape Town
Tuberculosis, Multidrug-Resistant
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs.
- Trial name
- DRAMATIC (NCT03828201)
- Testing
- Delamanid, Levofloxacin, Bedaquiline
- Where
- 2 sites in Philippines, Vietnam
- Volunteers
- 271 people
- Sponsor
- Boston University
Multi-drug Resistant Tuberculosis
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
- Trial name
- NCT03470233
- Where
- 2 sites in South Korea
- Volunteers
- 149 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis
Novel Triple-dose Tuberculosis Retreatment Regimen
To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent…
- Conditions
- Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs
- Trial name
- Tri-Do-Re (NCT04260477)
- Testing
- 6EH³R³Z, 6EHRZ
- Where
- Niger
- Volunteers
- 370 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Tuberculosis, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multidrug-Resistant, HIV
Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
This is a multisite prospective cohort study of patients with multidrug- or rifampin-resistant tuberculosis who are treated with an all-oral shortened regimen under routine program conditions in one of three countries (Peru…
- Trial name
- STEM-TB (NCT05871489)
- Testing
- Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months), Bdq, Lzd, Lfx, Cfz, Cs (9-12 months), Bdq, Lzd, Lfx, Z, Dlm (9-12 months)
- Where
- 3 sites in Kazakhstan, Lesotho and 1 more
- Volunteers
- 800 people
- Sponsor
- Harvard Medical School (HMS and HSDM)
Tuberculosis, HIV
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed…
- Trial name
- NCT02906007
- Testing
- Bedaquiline
- Where
- 4 sites in Haiti, South Africa
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis Multi Drug Resistant Active, Rifampin-Resistant Pulmonary Tuberculosis
Oral Nutritional Supplementation and Weight Changes During Therapy in Malnourished Patients With Resistant Tuberculosis: A Clinical Trial
Tuberculosis increases energy demands and protein breakdown, leading to muscle wasting. Malnutrition and minimal weight gain less than 5% in first two months predict treatment failure.
- Conditions
- Tuberculosis Multi Drug Resistant Active, Rifampin-Resistant Pulmonary Tuberculosis, Pre-xdr tb
- Trial name
- NCT07058233
- Testing
- Oral nutritional supplementation
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- RSUP Persahabatan
Tuberculosis, Drug-resistant Tuberculosis
Brief Bactericidal Activity of Anti-Tuberculosis Drugs
The investigators will determine the bactericidal activity of high-dose isoniazid against M. tuberculosis isolates that are (1) susceptible to isoniazid at 2.0 mcg/ml but resistant at 0.1 and 0.4 mcg/ml or (2) susceptible at 0.4…
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis, Isoniazid Resistant Tuberculosis (Disorder)
- Trial name
- BBA (NCT02236078)
- Testing
- High dose isoniazid
- Where
- India
- Volunteers
- 18 people
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis, Multi Drug Resistant Tuberculosis
Evaluation of PCR Using DNA Extract From Slides and Filter Paper for the Detection of Tuberculosis and MDR-tuberculosis
Specimen transport from peripheral health structures to the National TB reference laboratory for MDR-TB identification presents a big challenge in term of sample management, safety, contamination and delays.
- Trial name
- NCT03137875
- Where
- Uganda
- Volunteers
- 122 people
- Sponsor
- Epicentre
Multidrug Resistant Tuberculosis
Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan
Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high…
- Trial name
- NCT02496572
- Testing
- Short course MDR-TB treatment regimen
- Where
- Uzbekistan
- Volunteers
- 110 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Drug-resistant Tuberculosis, Pulmonary Tuberculosis
Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort
This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B)…
- Conditions
- Drug-resistant Tuberculosis, Pulmonary Tuberculosis, Rifampin-resistant Tuberculosis
- Trial name
- INSPIRE-BDLL (NCT06649721)
- Testing
- bedaquiline, delamanid, linezolid
- Where
- 34 sites in China
- Volunteers
- 120 people
- Sponsor
- Huashan Hospital