Clinical trials: Drug Resistance, Multiple, Bacterial
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
Cirrhosis
Study Of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China
This is a national, investigator-initiated, multicenter, prospective, observational, web-based registry in hospitalized patients with cirrhosis across China.
- Trial name
- SONIC (NCT03676777)
- Where
- 23 sites in China
- Volunteers
- 1,232 people
- Sponsor
- Ruijin Hospital
Multi-drug Resistant Tuberculosis
PK of Levofloxacin in MDR-TB Patients
The emergence and spread of multi-drug resistant and extensively-drug resistant strains of Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and elimination, limiting treatment success rate at…
- Trial name
- NCT03000517
- Where
- Nepal
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
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
Tuberculosis, Multidrug Resistant Tuberculosis
An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis
This study aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional…
- Conditions
- Tuberculosis, Multidrug Resistant Tuberculosis, Extensively-drug Resistant Tuberculosis
- Trial name
- NEXT (NCT02454205)
- Testing
- Linezolid, Bedaquiline, Levofloxacin
- Where
- South Africa
- Volunteers
- 154 people
- Sponsor
- University of Cape Town
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
Tuberculosis
A Multidrug-resistant (MDR) and Extensively Drug- Resistant (XDR) Tuberculosis Study in Alsace
The purpose of this study is to examine the epidemiology of TB MR in Strasbourg and evaluate the second-line anti-tuberculosis treatments effectiveness, and the relevance and adequacy of the treatments with WHO recommendations.
- Trial name
- NCT03507816
- Where
- France
- Volunteers
- 22 people
- Sponsor
- University Hospital, Strasbourg, France
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081
This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with…
- Trial name
- WX-081 (NCT04608955)
- Testing
- WX-081, Bedaquiline, Standard treatment
- Where
- China
- Volunteers
- 99 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Bacterial Sensitivity Tests, Antimicrobial Drug Resistance
AMR-DetecTool for the Diagnostic of MDR Bacterial Infections
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria.
- Trial name
- AMR DetecTool (NCT05378217)
- Testing
- AMR LFIA Assay
- Where
- 3 sites in France, Hungary and 1 more
- Volunteers
- 167 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
COVID-19, Bacterial Infections
Incidence of Colonization by Multidrug-resistant Organisms in Mechanically Ventilated Patients With Severe COVID-19
Retrospective single-center cohort study to evaluate the incidence of colonization by multidrug-resistant organisms (MDRO) in mechanically ventilated patients admitted to a large intensive care unit (ICU) for severe acute…
- Conditions
- COVID-19, Bacterial Infections, Colonization, Asymptomatic
- Trial name
- MDR_in_Fiera (NCT05293418)
- Testing
- data collection
- Where
- Italy
- Volunteers
- 435 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Pulmonary Tuberculosis
A PAN-USR TB Multi-Center Trial
Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide.
- Trial name
- NCT06905522
- Testing
- Bedaquiline (B), Sitafloxacin (S), Linezolid (L)
- Where
- 3 sites in China
- Volunteers
- 610 people
- Sponsor
- Shenzhen Third People's Hospital
Multi Drug Resistant Organisms, Antibiotic Resistance
Characterization of the Synergistic Antibacterial Effect of Verapamil on Bacterial Isolates From Cancer Patients
Multidrug-resistant (MDR) bacteria represent a significant global health challenge, particularly among immunocompromised populations such as cancer patients undergoing chemotherapy.
- Trial name
- NCT07505446
- Testing
- verapamil
- Volunteers
- 100 people
- Sponsor
- Assiut University
Multi-drug Resistant Tuberculosis
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance capacity to deliver effective treatment and…
- Trial name
- NCT03830671
- Testing
- 18-month regimen containing 6 anti-TB drugs
- Where
- 20 sites in China
- Volunteers
- 515 people
- Sponsor
- Beijing Chest Hospital
Drug Resistance, Bacterial
Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes.
This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.
- Trial name
- R'EHPAD (NCT03248999)
- Testing
- rectal swab
- Where
- France
- Volunteers
- 264 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Multi-drug Resistant Tuberculosis
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
- Trial name
- NCT01600963
- Testing
- Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207, Treatment Failure During Follow-up Phase: TMC207
- Where
- 44 sites in Brazil, Cambodia and 15 more
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, Multidrug-Resistant
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible.
- Trial name
- NCT02573350
- Testing
- Delamanid, OBR
- Where
- 8 sites in China, Estonia and 4 more
- Volunteers
- 213 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
HIV Infection, MDR-TB
HIV and Multi-Drug Resistant Tuberculosis: a Study on Clinical Outcomes
This study aims to investigate the relationship between HIV infection and multi-drug resistant tuberculosis (MDR-TB) among affected individuals in Zahedan, Iran.
- Trial name
- NCT06671808
- Testing
- Examination of HIV Infection in Patients with Multi-Drug Resistant Tuberculosis (MDR-TB)
- Where
- Iran
- Volunteers
- 222,128 people
- Sponsor
- Zahedan University of Medical Sciences
Enterobacteriaceae Infections, Multi-antibiotic Resistance
FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae
Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes.
- Trial name
- FMT-CRE (NCT04759001)
- Testing
- Donor FMT
- Where
- Italy
- Volunteers
- 52 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Multidrug Resistant Gram Negative Bacterial Infections
Multicentric Study About the Usefulness of Monitoring Plasma Levels of Colistin and Sodium Colistimethate in Patients With Infections Due to Multi-drug Resistant Gram Negative Bacilli, Treated With Colistin
Objectives: Main objective: to assess the impact of an intervention for optimizing the dosing of colistin based on its plasma levels in patients with infections due to multi-drug resistant gram negative bacilli.
- Trial name
- NCT01845246
- Testing
- Prospective TDM Arm of colistin
- Where
- 3 sites in Spain
- Volunteers
- 101 people
- Sponsor
- Parc de Salut Mar