Clinical trials: Multidrug-Resistant Bacterial Infections
Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis
Line Probe Assay Evaluation Study
This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from…
- Conditions
- Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis, Rifampicin Resistant Tuberculosis, Pulmonary Tuberculoses
- Trial name
- YD (NCT02984579)
- Testing
- YD REBA MTB-MDR, Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2
- Volunteers
- 888 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis
Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course…
- Conditions
- Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis, MDR-TB, RR-TB
- Trial name
- AHA-PLUS (NCT07393438)
- Testing
- Acetohydroxamic Acid
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
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
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
Tuberculosis, Multidrug-Resistant, Tuberculosis
Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)
endTB-Q Clinical Trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of two new, all-oral, shortened regimens for multidrug-resistant tuberculosis…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary Tuberculoses, Mycobacterial Infections
- Trial name
- endTB-Q (NCT03896685)
- Testing
- Bedaquiline 100 MG, Delamanid 50 MG Oral Tablet, Clofazimine 100 MG Oral Capsule
- Where
- 10 sites in India, Kazakhstan and 4 more
- Volunteers
- 323 people
- Sponsor
- Médecins Sans Frontières, France
Tuberculosis, Multidrug-Resistant
Treatment Shortening of MDR-TB Using Existing and New Drugs
The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen…
- Trial name
- MDR-END (NCT02619994)
- Testing
- Linezolid, Delamanid, Levofloxacin
- Where
- South Korea
- Volunteers
- 214 people
- Sponsor
- Seoul National University Hospital
Lung Tuberculosis, MDR TB
Tuberculosis Research of INA-RESPOND On Drug Resistance
This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray…
- Trial name
- TRIPOD (NCT02758236)
- Testing
- No Intervention
- Where
- 7 sites in Indonesia
- Volunteers
- 490 people
- Sponsor
- Ina-Respond
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
Clinically Significant Bacteremia, Organ Transplantation
Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
Main objective: to observationally assess the efficacy and safety of different antimicrobials in BSI due to ESBL or carbapenemase-producing Enterobacterales in SOT. Secondary objectives: 1.
- Conditions
- Clinically Significant Bacteremia, Organ Transplantation, Infection, Bacteremia
- Trial name
- INCREMENT-SOT (NCT02852902)
- Where
- 3 sites in Spain
- Volunteers
- 820 people
- Sponsor
- Spanish Network for Research in Infectious Diseases
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)
Liver Cirrhosis
Efficacy of Vitamin C on AKI Outcomes in Critically Ill Cirrhotics With Multidrug-resistant Bacterial Infections.
In this prospective randomized controlled trial we aim to evaluate the impact of vitamin C on AKI outcomes in patients with cirrhosis and MDR infections.
- Trial name
- NCT04494451
- Testing
- Vit C, Standard medical Treatment
- Where
- India
- Volunteers
- 100 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Tuberculosis
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB.
- Trial name
- NCT00449644
- Testing
- TMC207, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- Where
- 16 sites in Brazil, India and 6 more
- Volunteers
- 208 people
- Sponsor
- Janssen Infectious Diseases BVBA
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
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.
Multidrug-Resistant Gram-Negative Bacterial Infections, Antimicrobial Resistance
The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections
This study evaluates whether adding melatonin to standard colistin therapy improves outcomes in patients with multidrug-resistant (MDR) Gram-negative bacterial infections.
- Trial name
- NCT07503600
- Testing
- Melatonin
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
Neisseria Gonorrhoeae (Ng) Infections
Efficacy of Temocillin Compared to Standard of Care in the Treatment of Neisseria Gonorrhoeae Infections
Neisseria gonorrhoeae (Ng) infections are common and increasing in incidence. Treatment with a third generation cephalosporin, i.e ceftriaxone 1g, single dose, intramuscular (IM), is recommended as a first line treatment.
- Trial name
- TEMtoGo (NCT07631364)
- Testing
- Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml), Rectal swab for ESBL-E and microbiota (Eswab), Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml)
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Multidrug-resistant Tuberculosis, Extensively Drug-resistant Tuberculosis
Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients
Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA) in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) due to possible synergistic activity as…
- Trial name
- NCT01521364
- Testing
- Addition of different doses of clarithromycin.
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- University Medical Center Groningen
Infant Newborn Disease
Multidrug Resistant Gram-negative Pathogen Infections in High Risk Neonates in the Northeast of Mexico
The main objective of this project is to establish a prospective cohort to measure the Gram-negative infection burden in neonates under special care in a regional referral hospital, and to characterize all microorganisms isolates…
- Trial name
- InfGNMDR-Neo (NCT04812847)
- Testing
- Identification of MDR characteristics
- Where
- Mexico
- Volunteers
- 597 people
- Sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
Tuberculosis, MDR
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance.
- Trial name
- FS-1 (NCT02607449)
- Testing
- FS-1
- Where
- 6 sites in Kazakhstan, Kyrgyzstan
- Volunteers
- 344 people
- Sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan