Clinical trials: Infection Resistant to Multiple Drugs
HIV-1-infection
Investigating the Optimal Management of Dolutegravir Resistance
The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen.
- Trial name
- NCT06762054
- Testing
- Continue DTG-based antiretroviral therapy, Enhanced adherence counselling
- Where
- 9 sites in Kenya, Lesotho and 2 more
- Volunteers
- 6,624 people
- Sponsor
- University of Nairobi
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Linezolid, Tuberculosis Multi Drug Resistant Active
Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health. Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023.
- Conditions
- Linezolid, Tuberculosis Multi Drug Resistant Active, Therapeutic Drug Monitoring (TDM)
- Trial name
- PLOT-TB (NCT07477119)
- Testing
- Linezolid dose personalization based on TDM
- Where
- Guinea
- Volunteers
- 150 people
- Sponsor
- Marco Schiuma
Pulmonary Tuberculosis
A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture…
- Trial name
- NCT02333799
- Testing
- Bedaquiline, PA-824, Linezolid
- Where
- 3 sites in South Africa
- Volunteers
- 109 people
- Sponsor
- Global Alliance for TB Drug Development
Healthcare Associated Infection, Multidrug Resistant Organisms
Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)
This study examines the impact of UV-C light disinfection as an adjunct to routine daily and discharge patient room cleaning on patient infection and colonization with hospital associated bacteria.
- Trial name
- UVCLEAR-MDRO (NCT02605499)
- Testing
- UV-C light disinfection
- Volunteers
- 83 people
- Sponsor
- Johns Hopkins University
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
Malaria, Falciparum
A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC)
This study is an open-label randomised trial comparing standard ACT treatment with matching triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and tolerability.
- Trial name
- TRACII (NCT02453308)
- Testing
- ACT, TACT
- Where
- 20 sites in Bangladesh, Burma and 6 more
- Volunteers
- 1,110 people
- Sponsor
- University of Oxford
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.
Infections Nervous System, Nosocomial Infection
Infections Following NeuroSurgery (INS)
Neurosurgery (NS) is essential for the treatment of various diseases such as malignant tumors, vascular conditions, spinal stenosis or trauma.
- Conditions
- Infections Nervous System, Nosocomial Infection, Bacterial Infections, Antibiotic Resistant Infection
- Trial name
- INS (NCT03857295)
- Testing
- No interventions
- Volunteers
- 150 people
- Sponsor
- Neuromed IRCCS
Infections Resistant to Multiple Drugs, Bacterial Infections
Multi-Drug Resistant Organism Network
This study is specifically designed to provide observational data which can be used to help in the design of future randomized clinical trials on both therapeutics and diagnostics for MDRO infections.
- Trial name
- MDRO Network (NCT03646227)
- Testing
- Standard of Care
- Where
- 4 sites in United States, Australia and 2 more
- Volunteers
- 6,496 people
- Sponsor
- Duke University
Multidrug Resistant Klebsiella Pneumoniae Infection
Phenotypic and Genotypic Detection of Biofilm Formation and Efflux Pump Activity in Multi-drug Resistant Klebsiella Pneumoniae
1. Sample: urine, pus and sputum samples. 2. Culture: the samples will be inoculated on the MacConkey agar and subcultured on eosine methylene blue agar. 3. Identification of isolates will be done by: Colony morphology.
- Trial name
- Klebsiella (NCT07541690)
- Testing
- Genotypic Detection of Biofilm Formation and Efflux Pump Activity.
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Sohag University
Tuberculosis Multi Drug Resistant Active, Rifampin-Resistant Pulmonary Tuberculosis
Oral Nutritional Supplementation and Weight Changes During Therapy in Malnourished Patients With Resistant Tuberculosis: A Clinical Trial
Tuberculosis increases energy demands and protein breakdown, leading to muscle wasting. Malnutrition and minimal weight gain less than 5% in first two months predict treatment failure.
- Conditions
- Tuberculosis Multi Drug Resistant Active, Rifampin-Resistant Pulmonary Tuberculosis, Pre-xdr tb
- Trial name
- NCT07058233
- Testing
- Oral nutritional supplementation
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- RSUP Persahabatan
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
Pneumonia, Pulmonary Tuberculosis
Interferon Gamma for Drug Resistant Tuberculosis
This study will determine what dose of recombinant interferon-gamma is safe and effective for treating multiple drug-resistant tuberculosis.
- Trial name
- NCT00001407
- Testing
- Interferon Gamma
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-infection, Multi-Antiviral Resistance
Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
The PRESTIGIO Registry is an Observational, prospective, multicentre study that includes patients, regularly followed by Italian Infectious Disease Centres, with HIV-1 infection and documented resistance to the 4 classes of…
- Trial name
- PRESTIGIO (NCT04098315)
- Testing
- REGISTER CREATION
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Castagna Antonella
Bone and Osteoarticular Infection Due to MDR M. Tuberculosis Strains
Bone Resistant Tuberculosis
The recommendations for the treatment of MDR tuberculosis are based on pulmonary tuberculosis since there is a lack of specific recommendations for TB bone and osteoarticular disease, including those due to multi drug resistance…
- Trial name
- TboneR (NCT04928378)
- Testing
- Descriptive retrospective study
- Where
- France
- Volunteers
- 23 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris