Clinical trials: Multidrug-Resistant Bacterial Infections
Tuberculosis, Tuberculosis, Pulmonary
Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
This study is a retrospective cohort study. The purpose of this study is to investigate clinical features of the patients with the cavitary pulmonary tuberculosis (TB) and endobronchial TB from the patients who have been…
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Cavity, Bronchoscopy
- Trial name
- NCT03822156
- Testing
- Observation of AFB smear/culture
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- University of Ulsan
Tuberculosis, Multidrug-Resistant
Bioneer Q-RFIA Clinical Evaluation
Robust evidence on the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is required to comprehensively evaluate validity of the Bioneer RFIA assay to support both…
- Trial name
- NCT05117788
- Testing
- Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac
- Where
- 5 sites in Kenya, Moldova and 3 more
- Volunteers
- 2,350 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
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
Multi Drug Resistant Infections, Pneumnia
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
This is a multicenter prospective observational cohort study involving hospitalized adult patients with multidrug-resistant bacterial pneumonia.
- Trial name
- MDRBP-TCM (NCT07726095)
- Where
- China
- Volunteers
- 652 people
- Sponsor
- Henan University of Traditional Chinese Medicine
Multi-drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).
- Trial name
- LiMiT (NCT00664313)
- Testing
- Linezolid
- Where
- South Africa
- Volunteers
- 36 people
- Sponsor
- Centers for Disease Control and Prevention
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
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
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
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
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
PRACTECAL-PKPD Sub Study
PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial investigational regimens and…
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis
- Trial name
- PRACTECAL-PKPD (NCT04081077)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 5 sites in Belarus, South Africa
- Volunteers
- 240 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
MDR-TB
A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB
This is an exploratory, prospective, randomized, active control, and open label clinical trial to evaluate the efficacy and safety of 6-9 months treatment with the ultrashort PRS Regimen V.
- Trial name
- NCT05278988
- Testing
- PRS Regimen V, MDR-TB Treatment Regimen(WHO)
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Multidrug Resistant Bacterial Infection, Enterobacteriaceae Infections
PMT for MDRO Decolonization
This is a randomized, open label, comparative Phase II trial being conducted to determine whether fecal microbiota transplant using Penn Microbiome Therapy (PMT) products helps standard therapy eradicate antibiotic-resistant…
- Conditions
- Multidrug Resistant Bacterial Infection, Enterobacteriaceae Infections, Pseudomonas Aeruginosa, VRE Infection
- Trial name
- NCT05632315
- Testing
- PMT
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of Pennsylvania
Multidrug Resistant Tuberculosis
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in…
- Trial name
- TB-TRUSTplus (NCT04717908)
- Testing
- Bedaquiline, Pyrazinamide, Linezolid
- Where
- 15 sites in China
- Volunteers
- 89 people
- Sponsor
- Huashan Hospital
MDR-TB
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing.
- Trial name
- STREAM (NCT02409290)
- Testing
- Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline), Moxifloxacin, Clofazimine
- Where
- 13 sites in Ethiopia, Georgia and 5 more
- Volunteers
- 588 people
- Sponsor
- IUATLD, Inc
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.
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)
Multi-Drug Resistant Tuberculosis
New Genomic Techniques and Management of Multidrug-resistant Tuberculosis
In the context of the emergence of cases of multidrug-resistant tuberculosis (MDR-TB) it is crucial to improve patient's management.
- Trial name
- GENO-MDR (NCT04397536)
- Where
- France
- Volunteers
- 172 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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 Bacterial Infection
Cefiderocol in the Treatment of Multidrug-resistant Gram-negative Bacilli Infections, a Retrospective Study
Cefiderocol is a new antibiotic from the siderophore cephalosporin family for which there are few real-life data on its use in the treatment of infections with multidrug-resistant Gram-negative bacilli.
- Trial name
- CefiNoFer (NCT05544682)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Strasbourg, France