Clinical trials: Multidrug-Resistant Bacterial Infections
Multi-drug Resistant Tuberculosis
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
India has the highest incidence of and mortality from multi-drug resistant tuberculosis (MDR-TB) globally. Vitamin D status may be an important determinant of MDR-TB infection and treatment outcomes; however, observational…
- Trial name
- NCT04342598
- Testing
- Serum Vitamin D
- Where
- India
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Multi-drug Resistant Tuberculosis
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.
- Trial name
- TB-MR (NCT03057756)
- Testing
- Km+ Mfx+ Pto + H + Cfz +E+Z
- Where
- Gabon
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Multidrug-resistant Tuberculosis (MDR-TB)
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge in Central Africa. Understanding the molecular epidemiology and genotypic characteristics of MDR-TB strains is crucial for effective control measures.
- Trial name
- MESTCAR (NCT07017803)
- Where
- 8 sites in Gabon
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Pulmonary Disease, Tuberculosis, Pulmonary
A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT05526911
- Testing
- TBAJ-876, Midazolam, Digoxin
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Latent Tuberculosis
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
- Trial name
- NCT02454738
- Testing
- Ultralow dose chest CT scan
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Bacterial Infections, HIV Infections
Risk-factors for Multidrug-resistant Bacteria Colonization Among Patients at High Risk of STIs
The aim of this study is to identify risk factors and prevalence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria colonization among patients at high risk of STIs
- Trial name
- BMR-IST (NCT03767374)
- Testing
- Inguinal swab sample, Anal swab sample, Fecal sample
- Where
- France
- Volunteers
- 2,186 people, healthy volunteers welcome
- Sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Multidrug Resistant Tuberculosis
Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
PRACTECAL-PRO is a sub-study of a TB-PRACTECAL clinical trial for multidrug resistant Tuberculosis. It evaluates the effectiveness of TB-PRACTECAL interventions from the patient perspective in terms of their quality of life…
- Trial name
- PRACTECAL-PRO (NCT03942354)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 6 sites in Belarus, South Africa and 1 more
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Medecins Sans Frontieres, Netherlands
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)
Multidrug Resistant Bacterial Infection
Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
The overall goal of the ChlorHexidine gluconate (CHG) bAthing pRotocol for healthcare settings in low- and Middle-income countries (CHARM) study is to explore the safety, efficacy and feasibility of utilizing a locally prepared…
- Trial name
- CHARM (NCT06590675)
- Testing
- Chlorhexidine Gluconate (CHG)
- Where
- Botswana
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Antimicrobial Drug Resistance, Antibiotic Resistant Infection
Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
The goal of this observational study is to investigate how bacterial populations from the intestine and mouth of patients change during the hospitalization period and evaluate if some populations of specific bacteria increase or…
- Conditions
- Antimicrobial Drug Resistance, Antibiotic Resistant Infection, Clostridium Difficile, Carbapenem-Resistant Enterobacteriaceae Infection
- Trial name
- DYNAMITE (NCT06258551)
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
- Trial name
- NCT04150224
- Testing
- PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Extended Spectrum Beta Lactamases (ESBL) E. Coli
Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli
This study is to identify and isolate well-defined microbials (non-ESBL E. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with ESBL E. coli.
- Trial name
- NCT04764500
- Testing
- examination of stool sample, patient questionnaire, examination of blood sample
- Where
- Switzerland
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
HIV-1-infection, Pneumocystis Pneumonia
Impact of Cotrimoxazole Use in Immunocompetent HIV Patients on Carriage of Antimicrobial Resistant Bacteria
Cotrimoxazole preventive therapy (CPT) is recommended for prevention of morbidity and mortality due to Pneumocystis pneumonia and other infections in HIV positive patients with low immunity.
- Conditions
- HIV-1-infection, Pneumocystis Pneumonia, Opportunistic Infections, Preventive Therapy
- Trial name
- CoTrimResist (NCT03087890)
- Testing
- Cotrimoxazole
- Where
- 6 sites in Tanzania
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- University of Bergen
TB Multi-drug Resistant
Epidemiology of MDR-TB in Peru
The purpose of this study is to better understand tuberculosis (TB) and the risk of infection with TB, in Peru. TB is a disease that is caused by bacteria and transmitted through droplets in the air that come from the lungs of an…
- Trial name
- Estudio Epi (NCT00676754)
- Testing
- Statens Serum Institut RT23 2TU tuberculin
- Where
- Peru
- Volunteers
- 18,544 people, healthy volunteers welcome
- Sponsor
- Harvard University Faculty of Medicine
Pulmonary Disease, Tuberculosis, Pulmonary
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to…
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04493671
- Testing
- TBAJ-876 suspension, TBAJ-876 100 mg tablet, TBAJ-876 25 mg tablet
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Multidrug-resistant
Biomarkers for Therapy Response in Drug-resistant Tuberculosis
Multi-center, observational, prospective cohort study including patients with multidrug-resistant tuberculosis at different sites in Germany. The aim the study is the identification of biomarkers for therapy response.
- Trial name
- NCT02597621
- Testing
- no intervention
- Where
- Germany
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Research Center Borstel
Multidrug Resistant Tuberculosis
MDR-TB Close Contacts Tracing in China (TCCT Study)
To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.
- Trial name
- NCT04484129
- Where
- 8 sites in China
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Huashan Hospital
Multi-drug Resistant Tuberculosis
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
- Trial name
- NCT04309656
- Testing
- Pretomanid
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Multi-Drug Resistant Tuberculosis in Korea
This study, conducted in Korea, will examine why some people are more susceptible to tuberculosis (TB) than others and why some strains of M tuberculosis (the bacteria that causes TB) are more difficult to treat or become…
- Trial name
- NCT00341601
- Where
- 2 sites in South Korea
- Volunteers
- 777 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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