Clinical trials: Infection Resistant to Multiple Drugs
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
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
Multidrug Resistant Gram Negative Bacterial Infections
Multicentric Study About the Usefulness of Monitoring Plasma Levels of Colistin and Sodium Colistimethate in Patients With Infections Due to Multi-drug Resistant Gram Negative Bacilli, Treated With Colistin
Objectives: Main objective: to assess the impact of an intervention for optimizing the dosing of colistin based on its plasma levels in patients with infections due to multi-drug resistant gram negative bacilli.
- Trial name
- NCT01845246
- Testing
- Prospective TDM Arm of colistin
- Where
- 3 sites in Spain
- Volunteers
- 101 people
- Sponsor
- Parc de Salut Mar
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
Enterobacteriaceae Infections, Multi-antibiotic Resistance
FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
Antibiotic resistance (AR) is a critical public health threat and one of the greatest challenges of the 21st century. In an estimate of 2019, nearly 700.000 infections and 33.000 attributable deaths from multi-drug-resistant…
- Trial name
- FMT_CRE (NCT05791396)
- Testing
- Donor - FMT
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Drug Resistance, Multiple, Bacterial Infections
Prediction of Multidrug-resistant Bacterial Infection in Patients with Cirrhosis
The aim of this study is to identify predictive factors of infections caused by multidrug-resistant organisms in patients with cirrhosis and to develop and validate (internally and externally) a predictive model that might be…
- Conditions
- Drug Resistance, Multiple, Bacterial Infections, Liver Cirrhosis
- Trial name
- NCT05641025
- Where
- Argentina
- Volunteers
- 1,774 people
- Sponsor
- Hospital Italiano de Buenos Aires
Multi Drug Resistant Infections
Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen
To compare the clinical response (efficacy) and the safety of the tigecycline once daily regimen versus the standard regimen (twice daily regimen).
- Trial name
- NCT07258225
- Testing
- Tigecycline once daily regimen, Usual doses of tigecycline
- Where
- Egypt
- Volunteers
- 86 people
- Sponsor
- Air Force Specialized Hospital, Cairo, Egypt
Tuberculosis, Multidrug-Resistant
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB)…
- Trial name
- NCT02365623
- Testing
- TMC207 (bedaquiline), Background Regimen (BR)
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Janssen Pharmaceutical K.K.
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
Drug Resistance, Multiple, Bacterial, Cholangiopancreatography, Endoscopic Retrograde
Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries
The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use.
- Trial name
- PREVENT (NCT05303662)
- Testing
- Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs, MDRO-testing duodenal aspirate, Microbiome through rectal swab
- Where
- 4 sites in United States, India and 2 more
- Volunteers
- 1,244 people
- Sponsor
- Marco J. Bruno
Multi-Drug Resistant Hiv-1 Infection, HIV-1 Infection
A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection
Background: People with HIV usually take a combination of 2 or more anti-HIV drugs daily to help manage their infection. Sometimes, however, HIV becomes resistant to these drugs, and the infection cannot be treated.
- Trial name
- NCT05582694
- Testing
- UB-421
- Where
- United States
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects.
- Trial name
- NCT02707861
- Testing
- ibalizumab, Optimized Background Regimen
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 79 people
- Sponsor
- TaiMed Biologics Inc.
Tuberculosis, Multidrug-Resistant
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible.
- Trial name
- NCT02573350
- Testing
- Delamanid, OBR
- Where
- 8 sites in China, Estonia and 4 more
- Volunteers
- 213 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Cirrhosis, Ascites
Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis
Nosocomial spontaneous bacterial peritonitis (SBP) is frequently caused by multi drug resistant bacteria. Standard treatment of SBP could be ineffective.
- Conditions
- Cirrhosis, Ascites, Nosocomial Spontaneous Bacterial Peritonitis
- Trial name
- NCT01455246
- Testing
- Daptomycin + Meropenem, Ceftazidime
- Where
- Italy
- Volunteers
- 32 people
- Sponsor
- University of Padova
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
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
Severe Acute Malnutrition, Health Care Associated Infection
Prevention of Nosocomial Infections (CleanKids)
While the standardization of treatment protocols for Severe Acute Malnutrition (SAM) has helped to reduce historically high mortality, mortality in inpatient settings remains substantial, likely due to the severity of…
- Conditions
- Severe Acute Malnutrition, Health Care Associated Infection, Multi Drug Resistant Organisms
- Trial name
- CleanKids (NCT03360877)
- Testing
- Health-care associated infection (HCAI)
- Volunteers
- 4,944 people
- Sponsor
- Epicentre
Bacterial Resistance, Infection Resistant to Multiple Drugs
SATURN 04 Nosocomial Acquisition Study
The study is the WP4 of the EU-funded (7th FW) project SATURN (Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria). A total of 6 surgical and 6 medical wards will participate in the study.
- Conditions
- Bacterial Resistance, Infection Resistant to Multiple Drugs, Staph Aureus Methicillin Resistant Colonization, Infection Due to ESBL Bacteria
- Trial name
- SATURN (NCT01208519)
- Where
- 3 sites in Italy, Romania and 1 more
- Volunteers
- 16,680 people
- Sponsor
- Catholic University of the Sacred Heart
Pulmonary Tuberculosis
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid…
- Trial name
- NCT05971602
- Testing
- Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)
- Where
- 13 sites in Philippines, South Africa
- Volunteers
- 93 people
- Sponsor
- Gates Medical Research Institute