Clinical trials: Multiple-drug Resistance
Tuberculosis
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
- Trial name
- NC-005 (NCT02193776)
- Testing
- PA-824, bedaquiline, moxifloxacin
- Where
- 10 sites in South Africa, Tanzania and 1 more
- Volunteers
- 240 people
- Sponsor
- Global Alliance for TB Drug Development
Bacterial Infection, Multiple-drug Resistance
Intravenous Fosfomycin Pharmacokinetics Study
This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window).
- Conditions
- Bacterial Infection, Multiple-drug Resistance, Pathogen Resistance
- Trial name
- NCT03910673
- Testing
- Fosfomycin disodium
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Intra-Abdominal Infections, Skin Disease, Infectious
Tygacil Drug Use Investigation
Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
- Trial name
- TIGER (NCT01789905)
- Testing
- Tigecycline (Tygacil)
- Volunteers
- 116 people
- Sponsor
- Pfizer
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
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
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
- Trial name
- CAP (NCT00509106)
- Testing
- Ceftaroline fosamil for Injection, Ceftriaxone
- Where
- 134 sites in United States, Argentina and 13 more
- Volunteers
- 622 people
- Sponsor
- Forest Laboratories
Type 2 Diabetes Mellitus, Impaired Glucose Tolerance
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies
This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated…
- Trial name
- NCT01068860
- Testing
- Canakinumab 150 mg
- Where
- 52 sites in United States, Australia and 5 more
- Volunteers
- 246 people
- Sponsor
- Novartis
Infection With Multi-drug Resistant Organisms
FMT for Multidrug Resistant Organism Reversal
This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infections due to organisms of…
- Trial name
- NCT02312986
- Testing
- Fecal microbiota transplantation (FMT)
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
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
Tuberculosis, Pulmonary, Drug Sensitive, Tuberculosis, Pulmonary, Multi Drug-resistant
Shortening Treatment by Advancing Novel Drugs
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with…
- Trial name
- STAND (NCT02342886)
- Testing
- Moxifloxacin, PA-824, Pyrazinamide
- Where
- 26 sites in Georgia, Kenya and 6 more
- Volunteers
- 284 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
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
Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus
Active Bathing to Eliminate Infection (ABATE Infection) Trial
The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units.
- Conditions
- Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms
- Trial name
- ABATE (NCT02063867)
- Testing
- Arm 2: Decolonization
- Where
- 52 sites in United States
- Volunteers
- 53 people
- Sponsor
- University of California, Irvine
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.
Hospitalization, Infection
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
This is a cluster-randomized trial of nursing homes to assess whether decolonization with routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce hospitalizations associated with infections, antibiotic…
- Trial name
- PROTECT (NCT03118232)
- Testing
- Chlorhexidine gluconate (CHG), Iodophor (10% povidone-iodine)
- Where
- 28 sites in United States
- Volunteers
- 13,952 people
- Sponsor
- University of California, Irvine
Infection Control
Enhanced Room Cleaning in Intensive Care Units to Reduce Gown and Glove Contamination With Multi-drug-resistant Bacteria
The purpose of this study is to determine whether extra cleaning of frequently-contaminated surfaces in intensive care rooms is effective in preventing contamination of disposable isolation gowns and gloves with multi-drug…
- Trial name
- NCT01481935
- Testing
- Enhanced cleaning of surfaces in ICU rooms
- Where
- United States
- Volunteers
- 190 people
- Sponsor
- University of Maryland, Baltimore
HIV Infections
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
- Trial name
- NCT02362503
- Testing
- BMS-663068
- Where
- 139 sites in United States, Argentina and 23 more
- Volunteers
- 371 people
- Sponsor
- ViiV Healthcare
Ovarian Cancer
Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
The objective of this study was to evaluate the efficacy and safety of alpelisib in combination with olaparib compared with single-agent cytotoxic chemotherapy in participants with platinum-resistant or platinum-refractory…
- Trial name
- NCT04729387
- Testing
- Alpelisib, Olaparib, Paclitaxel
- Where
- 93 sites in United States, Argentina and 24 more
- Volunteers
- 358 people
- Sponsor
- Novartis Pharmaceuticals
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
HIV Infections
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
- Trial name
- NCT00054717
- Testing
- Tipranavir, Ritonavir(r), Comparator Protease Inhibitor (CPI)
- Where
- 117 sites in United States, Australia and 2 more
- Volunteers
- 630 people
- Sponsor
- Boehringer Ingelheim