Clinical trials: Bacterial Resistance
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)
Skin and Subcutaneous Tissue Bacterial Infections, Skin Structures and Soft Tissue Infections
Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.
- Trial name
- NCT01984684
- Testing
- delafloxacin, vancomycin, aztreonam
- Where
- 94 sites in United States, Argentina and 14 more
- Volunteers
- 850 people
- Sponsor
- Melinta Therapeutics, Inc.
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
Staphylococcal Infection
Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight bacteria, [clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)] and wound care for the outpatient management of…
- Trial name
- NCT00730028
- Testing
- Trimethoprim-sulfamethoxazole, Clindamycin
- Where
- 6 sites in United States
- Volunteers
- 1,310 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Tuberculosis, HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant…
- Trial name
- NCT03141060
- Testing
- Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB
- Where
- 5 sites in India, South Africa and 1 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)
Infective Endocarditis
Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE
- Trial name
- NCT00638157
- Testing
- daptomycin, daptomycin and gentamicin
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Serious Bacterial Infection
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI)…
- Trial name
- NCT03580044
- Testing
- ATM-AVI, BAT
- Where
- 42 sites in United States, Argentina and 10 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Bacterial Pneumonia
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
- Trial name
- ATTAIN1 (NCT00107952)
- Testing
- Telavancin, Vancomycin
- Where
- United States
- Volunteers
- 761 people
- Sponsor
- Cumberland Pharmaceuticals
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
Staphylococcal Skin Infections, Abscesses
Staphylococcus Aureus Decolonization Study
The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather…
- Conditions
- Staphylococcal Skin Infections, Abscesses, Furunculosis, Staphylococcus Aureus
- Trial name
- SuDS (NCT00731783)
- Testing
- 2% Mupirocin Ointment, 4% Chlorhexidine liquid soap, Hygiene protocol
- Where
- United States
- Volunteers
- 183 people
- Sponsor
- Washington University School of Medicine
Staphylococcus Aureus
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body.
- Trial name
- NCT01011335
- Testing
- Monovalent rAT, Monovalent rLukS-PV, Bivalent rLukS-PV / rAT
- Where
- 2 sites in United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Skin Infections, Bacterial
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA.
- Trial name
- NCT00852540
- Testing
- Retpamulin Ointment, 1%, Linezolid
- Where
- 53 sites in United States
- Volunteers
- 410 people
- Sponsor
- Stiefel, a GSK Company
Staphylococcal Infection, Abscess
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA).
- Conditions
- Staphylococcal Infection, Abscess, Staphylococcal Skin Infection, Folliculitis
- Trial name
- NCT00352612
- Testing
- clindamycin, cephalexin
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Aaron Chen
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.
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.
Small Bowel Bacterial Overgrowth, Gastrointestinal Diseases
Transit Time and Bacterial Overgrowth Using SmartPill Capsule
The primary purpose of this exploratory study is to measure orocecal transit time using the SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath test.
- Conditions
- Small Bowel Bacterial Overgrowth, Gastrointestinal Diseases, Stomach Diseases, Digestive System Diseases
- Trial name
- NCT00577772
- Testing
- Xifaxan, SmartPill, Lactulose hydrogen breath test (H_2BT)
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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