Clinical trials: Infections Resistant to Multiple Drugs
HIV-1 Infection
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.
- Trial name
- NCT04406727
- Testing
- UB-421, Antiretroviral (ARV)
- Volunteers
- 50 people
- Sponsor
- United BioPharma
Malaria, Falciparum
Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam
This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the ACT artemether-lumefantrine (AL) in…
- Trial name
- TACT-CV (NCT03355664)
- Testing
- ACT, TACT
- Where
- 4 sites in Cambodia, Vietnam
- Volunteers
- 310 people
- Sponsor
- University of Oxford
Infection
MDR Bacilli Surveillance and Clinical Feature in China
Objective 1. To evaluate the impact of MDR pathogen on prognosis and therapy cost; 2. To compare the efficacy of different antibiotics in treatment of infection caused by MDR pathogens; 3.
- Trial name
- MDR (NCT02140853)
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Sun Yat-sen University
Trauma, Resistant Infection
Polymyxin B Monotherapy vs Combination Therapy in Critically Ill Patients With Multi-drug Resistant Pathogens
The purpose of this study is to assess the safety and efficacy of polymyxin B as monotherapy versus a combined polymyxin B-carbapenem therapy against multidrug-resistant (MDR) gram negative infections.
- Conditions
- Trauma, Resistant Infection, Critical Illness
- Trial name
- MUSEUM (NCT03159078)
- Testing
- Polymyxin B
- Where
- Puerto Rico
- Volunteers
- 40 people
- Sponsor
- University of Puerto Rico
Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI)
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
- Conditions
- Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI)
- Trial name
- CREDIBLE - CR (NCT02714595)
- Testing
- Cefiderocol, Best Available Therapy
- Where
- 85 sites in United States, Brazil and 14 more
- Volunteers
- 152 people
- Sponsor
- Shionogi
Multi-drug Resistant Tuberculosis
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.
- Trial name
- TB-MR (NCT03057756)
- Testing
- Km+ Mfx+ Pto + H + Cfz +E+Z
- Where
- Gabon
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
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
- 6,600 people
- Sponsor
- University of Nairobi
HIV-1-infection
Open-Label Multi-Centre Randomised Switch Study to Evaluate Virological Efficacy Over 96Weeks Of 2-Drug Therapy With Dolutegravir(DTG)/Rilpivirine(RPV) Fixed Dose Combination(FDC) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTI Mutation K103N
HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted Protease Inhibitor…
- Trial name
- WISARD (NCT05349838)
- Testing
- Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy
- Where
- 29 sites in Belgium, France and 4 more
- Volunteers
- 140 people
- Sponsor
- NEAT ID Foundation
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
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
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
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
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
Pseudomonas Infections, Pseudomonas Aeruginosa
Clinical Outcomes With Ceftolozane-tazobactam for MDR Pseudomonas Infections
This study will describe clinical outcomes in patients who received ceftolozane-tazobactam for a Pseudomonas aeruginosa infection. Primary outcomes include 30-day and in-hospital mortality.
- Trial name
- NCT03510351
- Testing
- Ceftolozane-Tazobactam
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Temple University
Multi Drug Resistant Organisms
Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients
This study aims to evaluate the impact of digestive carriage of multidrug-resistant organisms (MDRO) on the risk of healthcare-associated infections in hospitalized adult patients.
- Trial name
- NCT07134270
- Testing
- MDRO Rectal Screening, 30-Day Telephone Follow-Up
- Where
- Romania
- Volunteers
- 400 people
- Sponsor
- Valeriu Gheorghita
Bacterial Infection, Benign Neoplasm
Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant
This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant…
- Conditions
- Bacterial Infection, Benign Neoplasm, Malignant Neoplasm, Methicillin-Resistant Staphylococcus Aureus Infection
- Trial name
- NCT01817075
- Testing
- Chlorhexidine Gluconate Skin Cleanser, Laboratory Biomarker Analysis, Mild Soap Skin Cleanser
- Where
- 59 sites in United States, Canada and 1 more
- Volunteers
- 177 people
- Sponsor
- Children's Oncology Group
HIV Infections, Multi-Antiviral Resistance
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV…
- Trial name
- PROMISE-US (NCT05388474)
- Testing
- No ibalizumab or Pre-ibalizumab treatment, On ibalizumab treatment
- Where
- 36 sites in United States
- Volunteers
- 168 people
- Sponsor
- Theratechnologies
Pneumonia, Ventilator-Associated, Colistin Adverse Reaction
Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates
This study is planned to compare the clinical efficacy and safety of aerosolized plus intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of ventilator-associated pneumonia (VAP) due to…
- Conditions
- Pneumonia, Ventilator-Associated, Colistin Adverse Reaction, Infection Due to Multidrug Resistant Acinetobacter, Infection Resistant to Multiple Drugs
- Trial name
- NCT02806141
- Testing
- Aerosolized plus intravenous colistin, Intravenous colistin
- Where
- Thailand
- Volunteers
- 204 people
- Sponsor
- Hat Yai Medical Education Center
Infectious Diseases
Safety and Efficacy Study of High Dose Colistin
Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.
- Trial name
- NCT02162966
- Testing
- High Dose Colistin, Standard Dose Colistin
- Where
- Saudi Arabia
- Volunteers
- 330 people
- Sponsor
- King Saud Medical City
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- ZeNix (NCT03086486)
- Testing
- Pretomanid, Linezolid, Bedaquiline
- Where
- 11 sites in Georgia, Moldova and 2 more
- Volunteers
- 181 people
- Sponsor
- Global Alliance for TB Drug Development