Clinical trials: Resistance Bacterial
Mycobacterium Infections, Nontuberculous
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary…
- Trial name
- OPTIMA (NCT03421743)
- Testing
- Inhaled molgramostim, Antimycobacterial regimen
- Where
- 5 sites in Australia, United Kingdom
- Volunteers
- 32 people
- Sponsor
- Savara Inc.
Tuberculosis
Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
The purpose of this study is: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background…
- Trial name
- NCT01131351
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 3 sites in Latvia, Lithuania
- Volunteers
- 10 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pulmonary Tuberculosis
Directly Observed Therapy Short Course-Plus Versus DOTS for Retreatment of Relapsed Pulmonary Tuberculosis in Guangzhou
This is a prospective, randomized, parallel, controlled study comparing the efficacy and outcomes in the retreatment of pulmonary Tuberculosis (TB) in Guangzhou in a group using pretreatment susceptibility tests in selection of…
- Trial name
- NCT01618422
- Testing
- Directly Observed Therapy (DOTS) plus, Directly Observed Therapy (DOTS)
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Chinese University of Hong Kong
Infections, Bacterial
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Single Dose and Repeat Dose of GSK3342830
A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled, dose-escalation study is conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of GSK3342830 after administration of…
- Trial name
- NCT02751424
- Testing
- GSK3342830
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bacterial Resistance
Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics
1. Background: Over 1 million intravitreal injections are performed annually in the United States. The most devastating complication related to these injections is endophthalmitis, with an incidence of 0.02 - 0.1% per injection.
- Trial name
- NCT02223338
- Testing
- Ciprofloxacin, Standard Aseptic Technique
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Loma Linda University
Healthy Volunteers, Anti-Bacterial Agents
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers
The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.
- Conditions
- Healthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus
- Trial name
- NCT01855048
- Testing
- N-Rephasin® SAL200
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Intron Biotechnology, Inc.
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, Multidrug-Resistant
Treatment Shortening of MDR-TB Using Existing and New Drugs
The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen…
- Trial name
- MDR-END (NCT02619994)
- Testing
- Linezolid, Delamanid, Levofloxacin
- Where
- South Korea
- Volunteers
- 214 people
- Sponsor
- Seoul National University Hospital
Bacterial Pneumonia
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
- Trial name
- ATTAIN2 (NCT00124020)
- Testing
- Telavancin, Vancomycin
- Where
- Israel
- Volunteers
- 771 people
- Sponsor
- Cumberland Pharmaceuticals
Staphylococcal Skin Infection
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
- Trial name
- ATLAS2 (NCT00107978)
- Testing
- Telavancin, Vancomycin
- Where
- United States
- Volunteers
- 1,035 people
- Sponsor
- Cumberland Pharmaceuticals
Healthcare Associated Infection, Clostridium Difficile Infection
Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection
The objective is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control)…
- Conditions
- Healthcare Associated Infection, Clostridium Difficile Infection, Infection Due to Multidrug Resistant Bacteria
- Trial name
- NCT03349268
- Testing
- Pulsed xenon ultraviolet (PX-UV) Device
- Where
- United States
- Volunteers
- 25,732 people
- Sponsor
- University of Michigan
MDR-TB, HIV
A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs.
- Trial name
- NCT02129244
- Testing
- NCM-Plus
- Where
- 15 sites in South Africa
- Volunteers
- 2,844 people
- Sponsor
- Johns Hopkins University
Infections
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant…
- Trial name
- NCT01645735
- Testing
- Ceftaroline fosamil, Ceftriaxone plus vancomycin
- Where
- 31 sites in United States, Georgia and 6 more
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Bacteremia, Soft Tissue Infections
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection…
- Conditions
- Bacteremia, Soft Tissue Infections, Skin Diseases, Infectious
- Trial name
- NCT03643952
- Testing
- Daptomycin for Injection
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC
Staphylococcal Skin Infections
Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA
This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin.
- Trial name
- DAPHEOR1006 (NCT01419184)
- Testing
- Daptomycin, Vancomycin
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 250 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Endocarditis, Bacterial, Infective Endocarditis
Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia
The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of…
- Trial name
- HDSAB (NCT00695903)
- Testing
- daptomycin, vancomycin
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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, Staphylococcal Infections
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
This study will prospectively evaluate the prevalence and incidence (over a two year period) of MRSA colonization and infection among HIV-infected military beneficiaries to determine predictors for the development of MRSA…
- Trial name
- MRSA (NCT00631566)
- Testing
- Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
- Where
- 4 sites in United States
- Volunteers
- 550 people
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia
Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia.
- Conditions
- Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia
- Trial name
- ATTACK (NCT03894046)
- Testing
- Sulbactam, Durlobactam, Colistin
- Where
- 90 sites in United States, Belarus and 15 more
- Volunteers
- 207 people
- Sponsor
- Entasis Therapeutics