Clinical trials: Multidrug-Resistant Bacterial Infections
Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis
Novel Triple-dose Tuberculosis Retreatment Regimen
To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent…
- Conditions
- Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs
- Trial name
- Tri-Do-Re (NCT04260477)
- Testing
- 6EH³R³Z, 6EHRZ
- Where
- Niger
- Volunteers
- 370 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Tuberculosis, Pre-XDR-TB
Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care
BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid…
- Conditions
- Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04062201
- Testing
- Bedaquiline Oral Tablet, Linezolid Oral Tablet, Delamanid in Oral Dosage Form
- Where
- 2 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Wits Health Consortium (Pty) Ltd
Multidrug Resistant Bacterial Infection
Development and Evaluation of a ChlorHexidine Gluconate bAthing pRotocol for Healthcare Settings in Low- and Middle-income Countries
The overall goal of the ChlorHexidine gluconate (CHG) bAthing pRotocol for healthcare settings in low- and Middle-income countries (CHARM) study is to explore the safety, efficacy and feasibility of utilizing a locally prepared…
- Trial name
- CHARM (NCT06590675)
- Testing
- Chlorhexidine Gluconate (CHG)
- Where
- Botswana
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Tuberculosis
TB Immunotherapy Trial With Heat-killed M. Vaccae
The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and…
- Trial name
- imm03 (NCT01977768)
- Testing
- V7
- Where
- 2 sites in Mongolia, Ukraine
- Volunteers
- 152 people
- Sponsor
- Immunitor LLC
Tuberculosis
Safety and Efficacy of Oral Immunomodulator in Tuberculosis (TB) and TB/HIV Patients
Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24 months) and more toxic treatment course.
- Trial name
- NCT01222338
- Testing
- V-5 immunitor
- Where
- Ukraine
- Volunteers
- 123 people
- Sponsor
- Lisichansk Regional Tuberculosis Dispensary
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
Aztreonam-Avibactam in Immunocompromised Hosts
The goal of this observational study is to learn about the effectiveness and safety of aztreonam-avibactam (ATM-AVI), an antibiotic used to treat infections caused by highly resistant bacteria, in adults with weakened immune…
- Conditions
- Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection, Immunocompromised Host, Drug Resistance, Multiple, Bacterial
- Trial name
- IMMUNO-AVI (NCT07890480)
- Testing
- Aztreonam-Avibactam, Ceftazidime-Avibactam Plus Aztreonam
- Where
- Argentina
- Volunteers
- 814 people
- Sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Tuberculosis, Multidrug-Resistant
High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis
The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB) in resource-limited countries is being increasingly recognized.
- Trial name
- NCT00513396
- Testing
- Isoniazid
- Volunteers
- 134 people
- Sponsor
- GSVM Medical College
Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection
A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections
This study aims to evaluate the clinical efficacy of a traditional Chinese medicine formula granule (Feireqing Granules) in the treatment of severe pneumonia caused by multidrug-resistant Gram-negative bacterial infections…
- Trial name
- NCT07206745
- Testing
- Fei Re Qing Granules
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Henan University of Traditional Chinese Medicine
Infection Due to Resistant Organism
FMT for MDRO Colonization After Infection in Renal Transplant Recipients
Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical…
- Trial name
- PREMIX (NCT02922816)
- Testing
- Fecal Microbiota Transplant (FMT), Bowel preparation, Stool or perirectal swab sampling
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Emory University
Bloodstream Infection, Ventilator Associated Bacterial Pneumonia
Optimising TREATment for Severe Gram-Negative Bacterial Infections
TREAT-GNB is an innovative trial to expedite the evaluation of various antibiotic choices and treatment strategies for severe multidrug-resistant Gram-negative bacterial infections, specifically bloodstream and lower respiratory…
- Conditions
- Bloodstream Infection, Ventilator Associated Bacterial Pneumonia, Hospital Acquired Bacterial Pneumonia, Carbapenem Resistant Bacterial Infection
- Trial name
- TREAT-GNB (NCT07004049)
- Testing
- Colistin/Polymyxin B + Sulbactam, Colistin/Polymyxin B + Tigecycline/Eravacycline, Colistin/Polymyxin B + Meropenem
- Where
- 41 sites in Australia, China and 10 more
- Volunteers
- 600 people
- Sponsor
- National University of Singapore
Tuberculosis, Multidrug-Resistant
Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis
Resistance to anti-tuberculosis drugs is a continually growing problem. Multidrug-resistant tuberculosis (MDRTB) is resistance to at least rifampicin and isoniazid, and extensively drug-resistant TB is additional resistance to a…
- Trial name
- T3-RCT (NCT05007795)
- Testing
- Targeted sequencing using the GenoScreen Deeplex assay
- Where
- South Africa
- Volunteers
- 280 people
- Sponsor
- University of Cape Town
Tuberculosis, Multidrug-Resistant
Expand New Drugs for TB [endTB]
This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB.
- Trial name
- NCT03259269
- Testing
- This is a non-intervention observational study
- Where
- 16 sites in Armenia, Bangladesh and 12 more
- Volunteers
- 2,804 people
- Sponsor
- Partners in Health
Tuberculosis, Tuberculosis, Multidrug-Resistant
Global Consortium for Drug-resistant Tuberculosis Diagnostics
The goal of this study is to evaluate time to diagnosis for three assays (line probe, pyrosequencing, and Microscopic Observation Drug Susceptibility Assay [MODS]) to detect resistance to first and second-line anti-tuberculosis…
- Trial name
- GCDD (NCT02170441)
- Where
- 3 sites in India, Moldova and 1 more
- Volunteers
- 1,128 people
- Sponsor
- University of California, San Diego
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
Clostridioides Difficile Infection, Drug Resistance, Bacterial
Effect of Oral Microbiota on MDRO Decolonization
Randomized, placebo-controlled trial to evaluate the safety and efficacy of oral intestinal microbiota capsules for decolonizing multidrug-resistant organisms (MDROs) and Clostridioides difficile in patients requiring prolonged…
- Conditions
- Clostridioides Difficile Infection, Drug Resistance, Bacterial, Gastrointestinal Microbiome, Multidrug-resistant Colonization
- Trial name
- NCT07496502
- Testing
- Microbiota capsule
- Where
- Mexico
- Volunteers
- 42 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tuberculosis, Multidrug-Resistant
Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less…
- Trial name
- NCT02354014
- Testing
- Bedaquiline (TMC207), Background Regimen (BR)
- Where
- 11 sites in Mozambique, Philippines and 4 more
- Volunteers
- 60 people
- Sponsor
- Janssen Research & Development, LLC
Rifampicin Resistant Tuberculosis, Pulmonary Tuberculosis
Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort
The goal of this clinical trial is to learn if the all-oral, shorter-course BLMZ regimen can treat Rifampicin-Resistant Tuberculosis (RR-TB) in Chinese participants aged 12 years and older.
- Conditions
- Rifampicin Resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Drug-resistant Tuberculosis
- Trial name
- INSPIRE-BLMZ (NCT07268664)
- Testing
- BLMZ
- Where
- 3 sites in China
- Volunteers
- 120 people
- Sponsor
- Beijing Chest Hospital
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
MDR-TB, Immunotherapy
A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB
A Exploratory Study of drug combination (zoledronic acid/interleukin 2) that specifically amplifies Vγ2Vδ2 T cells in combination with anti-tuberculosis chemotherapy for the treatment of MDR-TB.
- Trial name
- NCT05493267
- Testing
- Vγ2Vδ2 T lymphocyte-based immunotherapy, Treatment regimens for MDR-TB
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- NCT03338621
- Testing
- Pretomanid, Bedaquiline, Moxifloxacin
- Where
- 26 sites in Brazil, Georgia and 6 more
- Volunteers
- 455 people
- Sponsor
- Global Alliance for TB Drug Development