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, HIV Infections
Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis
This study evaluated the safety, tolerability, and pharmacokinetics of the anti-tuberculosis (TB) drugs bedaquiline (BDQ) and delamanid (DLM), alone and in combination, among participants (with or without HIV co-infection) taking…
- Trial name
- NCT02583048
- Testing
- Bedaquiline, Delamanid, Dolutegravir
- Where
- 3 sites in Peru, South Africa
- Volunteers
- 84 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Invasive Mold Infections
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections.
- Trial name
- NCT06925321
- Testing
- Fosmanogepix IV infusion, Standard of care antifungal therapy, Fosmanogepix oral tablet
- Where
- 90 sites in United States, Australia and 13 more
- Volunteers
- 234 people
- Sponsor
- Basilea Pharmaceutica
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
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
Economic Evaluation of New MDR TB Regimens
The current treatment regimen for MDR-TB has poor outcomes and costs of treating MDR-TB are greater than treating drug susceptible TB, both in terms of health service and patient-incurred costs.
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculoses
- Trial name
- PRACTECAL-EE (NCT04207112)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 7 sites in Belarus, South Africa and 1 more
- Volunteers
- 73 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2/3 clinical trial for…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR
- Trial name
- PRISM-TB (NCT06441006)
- Testing
- Bedaquiline, Linezolid, Pretomanid
- Where
- 6 sites in Mongolia, Pakistan and 3 more
- Volunteers
- 400 people
- Sponsor
- University of California, San Francisco
Tuberculosis
Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients
This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).
- Trial name
- NCT02169141
- Testing
- Pharmacokinetics
- Where
- Belarus
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
Tuberculosis
Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
The purpose of this study is: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background…
- Trial name
- NCT01131351
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 3 sites in Latvia, Lithuania
- Volunteers
- 10 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Multidrug-resistant
Nosocomial Transmission of MDR-TB in Bucharest, Romania
It is a single-center, observational, prospective cohort study recruiting patients hospitalized at the multidrug-resistant tuberculosis ward at Marius Nasta Institute.
- Trial name
- NCT02413931
- Testing
- Routine management practices applied
- Where
- Romania
- Volunteers
- 53 people
- Sponsor
- Research Center Borstel
Tuberculosis, Multidrug Resistant Tuberculosis
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with…
- Trial name
- TEDITUB (NCT05534750)
- Testing
- Tedizolid arm (SIVEXTRO®), Linezolid arm (ZYVOXID®), Standard quadruple therapy arm
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Infection Due to ESBL Escherichia Coli
Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli
Enterobacterieaceae (and specially Escherichia coli) showing resistance due to multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused by chromosomal mechanisms have spread worldwide during the…
- Trial name
- FOREST (NCT02142751)
- Testing
- Fosfomycin sodium intravenous, Meropenem intravenous, Ceftriaxone intravenous
- Where
- 22 sites in Spain
- Volunteers
- 161 people
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Tuberculosis, Pulmonary, Drug Sensitive, Tuberculosis, Pulmonary, Multi Drug-resistant
Shortening Treatment by Advancing Novel Drugs
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with…
- Trial name
- STAND (NCT02342886)
- Testing
- Moxifloxacin, PA-824, Pyrazinamide
- Where
- 26 sites in Georgia, Kenya and 6 more
- Volunteers
- 284 people
- Sponsor
- Global Alliance for TB Drug Development
Drug Resistant Tuberculosis, MDR-TB
Triage Test for All Oral DR-TB Regimen (TRiAD Study)
A Phase 4 operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB-A multi-centre, multi-country…
- Conditions
- Drug Resistant Tuberculosis, MDR-TB, XDR-TB, Tuberculosis
- Trial name
- NCT05175794
- Testing
- Xpert® MTB/XDR
- Where
- 4 sites in Ethiopia, Nigeria and 1 more
- Volunteers
- 786 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Sepsis
Evaluation of Usage Patterns and Outcomes in Patients Receiving Ceftolozane/Tazobactan (C/T) in Brazilian Hospitals
Ceftolozane/Tazobactan (C/T) is a recent option to manage multidrug resistant gram-negative infections in hospital patients. Despite several randomized controlled trials describing safety and efficacy of C/T, real world evidence…
- Trial name
- NCT05267483
- Testing
- No intervention
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- D'Or Institute for Research and Education
Drug Resistance, Multiple, Bacterial Infections
Prediction of Multidrug-resistant Bacterial Infection in Patients with Cirrhosis
The aim of this study is to identify predictive factors of infections caused by multidrug-resistant organisms in patients with cirrhosis and to develop and validate (internally and externally) a predictive model that might be…
- Conditions
- Drug Resistance, Multiple, Bacterial Infections, Liver Cirrhosis
- Trial name
- NCT05641025
- Where
- Argentina
- Volunteers
- 1,774 people
- Sponsor
- Hospital Italiano de Buenos Aires
Urinary Tract Infections, Recurrent Urinary Tract Infections
WMT for Multidrug-Resistant Organism UTI
This is a single-center, prospective, single-arm, exploratory clinical study to evaluate the efficacy, safety, and potential mechanisms of washed microbiota transplantation (WMT) in patients with recurrent urinary tract…
- Conditions
- Urinary Tract Infections, Recurrent Urinary Tract Infections, Multidrug-Resistant Bacterial Infections, Bacteriuria
- Trial name
- NCT07816913
- Testing
- Washed Microbiota Transplantation (WMT)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- The Second Hospital of Nanjing Medical 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.
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
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
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