Clinical trials: Multidrug-Resistant Bacterial Infections
Polymyxin B, Ventilator-associated Pneumonia
Comparison of Epithelial Lining Fluid and Blood Pharmacokinetics and Pharmacodynamics of Intravenous and Intravenous Plus Nebulized Polymyxin B in Multidrug Resistant Bacteria Ventilator-associated Pneumonia Patients
The goal of this observational study is to investigate whether intravenous polymyxin B combined with nebulisation achieves better antimicrobial efficacy and clinical outcomes than intravenous use alone in patients with…
- Conditions
- Polymyxin B, Ventilator-associated Pneumonia, Multidrug Resistant Bacterial Infection, Pharmacogenomic Drug Interaction
- Trial name
- NCT06076603
- Testing
- nebulized polymyxin B
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Southeast University, China
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
Linezolid Dosing Strategies in Drug-Resistant TB
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- NCT05007821
- Testing
- Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW)
- Where
- 13 sites in Botswana, Brazil and 5 more
- Volunteers
- 138 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Urinary Tract Infections, Bacterial Resistance
Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)
A retrospective observational study to assess the clinical management and outcomes of hospitalised patients with complicated urinary tract infection in countries with high prevalence of multidrug resistant gram-negative bacteria…
- Trial name
- RESCUING (NCT02641015)
- Where
- 21 sites in Bulgaria, Greece and 6 more
- Volunteers
- 1,028 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
MDR Tuberculosis, Resistance to Tuberculostatic Drugs
Artificial Inteligent for Diagnosing Drug-Resistant Tuberculosis
Title: Artificial Neural Network as Diagnostic Tools For Rifampicin-Resistant Tuberculosis In Indonesia. A Predictive Model Study and Economic Evaluation.
- Trial name
- NCT04208789
- Testing
- Rapid Molecular Drug-Resistant Tuberculosis Test, Artificial Intelligent Model, Drug Susceptibility Test
- Where
- 5 sites in Indonesia
- Volunteers
- 524 people
- Sponsor
- Hasanuddin University
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
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, 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
Rifampin-resistant Tuberculosis, Drug-resistant Tuberculosis
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
This study is a two-arm, pragmatic, open-label, randomized clinical trial to determine the efficacy of Therapeutic Drug Monitoring (TDM) in preventing premature discontinuation of Linezolid (LZD) in participants with…
- Trial name
- THERMOL (NCT06590428)
- Testing
- Therapeutic Drug Monitoring for Linezolid
- Where
- South Africa
- Volunteers
- 280 people
- Sponsor
- Albert Einstein College of Medicine
Tuberculosis, Multidrug-Resistant
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs.
- Trial name
- DRAMATIC (NCT03828201)
- Testing
- Delamanid, Levofloxacin, Bedaquiline
- Where
- 2 sites in Philippines, Vietnam
- Volunteers
- 271 people
- Sponsor
- Boston University
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
Multidrug Resistant Tuberculosis
Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide
Multidrug resistant tuberculosis (MDR-TB) is difficult to treat and raises a great challenge to TB control program. That pyrazinamide can shorten the course of treatment and facilitate bacilli clearance has been proved recently.
- Trial name
- NCT02120638
- Testing
- Pyrazinamide containing regimen, Regimen without Pyrazinamide
- Where
- 11 sites in China
- Volunteers
- 100 people
- Sponsor
- Huashan Hospital
Multidrug Resistant Tuberculosis
Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks…
- Trial name
- TB-TRUST (NCT03867136)
- Testing
- PZA sensitivity guided ultra-short all Oral Regimen, Standardized Shorter Regimen
- Where
- 13 sites in China
- Volunteers
- 354 people
- Sponsor
- Huashan Hospital
Tuberculosis, HIV
Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV
Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter in Ukraine. After many years of laboratory and clinical testing the formulation was approved in 1997 by the Ministry of Health of Ukraine…
- Trial name
- NCT01061593
- Testing
- Immunoxel
- Where
- 2 sites in Mongolia, Ukraine
- Volunteers
- 269 people
- Sponsor
- Lisichansk Regional Tuberculosis Dispensary
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
MDR TB
Study of Adjunctive Recombinant Human Interleukin-2 Therapy in Patients With MDR-TB
Multidrug-resistant tuberculosis (MDR-TB) has emerged as a challenge worldwide. Few studies have prospectively reported outcomes in patients with pulmonary MDR-TB treated with adjunctive immunotherapy combined to standard…
- Trial name
- rhIL-2 (NCT03069534)
- Testing
- RhIL-2
- Where
- China
- Volunteers
- 500 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Latent Tuberculosis
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
- Trial name
- NCT02454738
- Testing
- Ultralow dose chest CT scan
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Enterobacterial Infection
Impact of Beta-lactams on the Microbiota and Relative Fecal Abundance of Mulltidrug Resistant Bacteria
The global spread of ESBL-producing enterobacteria (EBLSE) poses a real public health problem. The exposure of patients to antibiotic therapy leads to an increase in resistant bacterial populations within the digestive flora.
- Trial name
- NCT03338738
- Testing
- Stool culture ans swab
- Where
- France
- Volunteers
- 19 people
- Sponsor
- Fondation Hôpital Saint-Joseph
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
Phage Therapy, Bacteriophage Therapy
Randomized Controlled Study on the Safety and Efficacy of Phage Cocktail in the Treatment of Multidrug-Resistant Bacterial Skin Infections
This study addresses the increasingly severe global public health challenge of antibiotic resistance, focusing on exploring phage therapy as a potential treatment strategy for multidrug-resistant bacterial skin infections.
- Conditions
- Phage Therapy, Bacteriophage Therapy, Skin and Soft Tissue Infections
- Trial name
- NCT07619924
- Testing
- Bacteriophage Treatment
- Where
- China
- Volunteers
- 150 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University