Clinical trials: Bacterial Resistance
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
Staphylococcal Skin Infections
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
- Trial name
- NCT00463801
- Testing
- Daptomycin
- Where
- 2 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Novartis
Candidemia
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in…
- Trial name
- NCT03604705
- Testing
- APX001
- Where
- 29 sites in United States, Belgium and 3 more
- Volunteers
- 21 people
- Sponsor
- Basilea Pharmaceutica
Skin Infections, Bacterial
GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection
This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).
- Trial name
- NCT01209078
- Testing
- GSK1322322, Linezolid
- Where
- 7 sites in United States
- Volunteers
- 84 people
- Sponsor
- GlaxoSmithKline
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.
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
Skin Diseases, Infectious
Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections
The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections (SSTI) and SSTI-related bacteremia).
- Trial name
- NCT01967225
- Testing
- Tedizolid Phosphate (Sivextro, BAY1192631), Linezolid
- Where
- 46 sites in Japan
- Volunteers
- 125 people
- Sponsor
- Bayer
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
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.
Bacterial Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- NCT00423657
- Testing
- ceftaroline, vancomycin plus aztreonam
- Where
- 54 sites in United States, Argentina and 10 more
- Volunteers
- 680 people
- Sponsor
- Forest Laboratories
Helicobacter Infections
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication.
- Trial name
- NCT00669955
- Testing
- Omeprazole, amoxicillin, clarithromycin, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
- Where
- United Kingdom
- Volunteers
- 440 people
- Sponsor
- Forest Laboratories
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
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.
Bacterial Infections
Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium+Imipenem+Cilastatin in Imipenem-Resistant Bacterial Infection (MK-7655A-013)
The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (MK-7655A) versus colistimethate sodium+imipenem+cilastatin in the treatment of imipenem-resistant bacterial infections.
- Trial name
- RESTORE-IMI 1 (NCT02452047)
- Testing
- Imipenem+Cilastatin/Relebactam, Colistimethate sodium (CMS), Imipenem+Cilastatin
- Volunteers
- 50 people
- Sponsor
- Merck Sharp & Dohme LLC
Invasive Fungal Infections
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.
- Trial name
- FORMULA-OLS (NCT03583164)
- Testing
- Olorofim
- Where
- 82 sites in United States, Australia and 15 more
- Volunteers
- 203 people
- Sponsor
- F2G Biotech GmbH
Staphylococcal Infection
A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA).
- Trial name
- NCT00770341
- Testing
- Daptomycin 4 mg/kg, Comparator: vancomycin, Daptomycin 6 mg/kg
- Volunteers
- 122 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
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
Skin Infection
Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
Primary Objective: To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.
- Trial name
- CG400549 (NCT01593761)
- Testing
- CG400549
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CrystalGenomics, Inc.
Bacterial Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- cSSSI (NCT00424190)
- Testing
- IV Vancomycin plus IV Aztreonam, Ceftaroline
- Where
- 52 sites in United States, Argentina and 9 more
- Volunteers
- 698 people
- Sponsor
- Forest Laboratories