Clinical trials: Gram-Positive Bacterial Infections
Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis
BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
This is a prospective, open label, two-centre, randomized, controlled, two-stage, phase Ib/IIa study to evaluate the safety, tolerability, PK, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once…
- Trial name
- NCT04044001
- Testing
- BTZ-043, Rifafour e-275®, Probe Drug Cocktail
- Where
- 2 sites in South Africa
- Volunteers
- 78 people
- Sponsor
- Michael Hoelscher
Gram-Positive Bacterial Infections
Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)
This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes
- Trial name
- NCT02013141
- Testing
- Telavancin
- Where
- 7 sites in United States
- Volunteers
- 22 people
- Sponsor
- Cumberland Pharmaceuticals
Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
- Trial name
- P2_ABSSSI (NCT03964493)
- Testing
- TNP-2092, Vancomycin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- TenNor Therapeutics Limited
Clostridioides Difficile Infection
ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible.
- Trial name
- NCT03183141
- Testing
- SER-109
- Where
- 107 sites in United States, Canada
- Volunteers
- 263 people
- Sponsor
- Seres Therapeutics, Inc.
Skin Diseases, Bacterial, Gram-Positive Bacterial Infections
Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
The purpose of this study is to determine whether contezolid acefosamil is as safe and effective as linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections
- Trial name
- NCT03747497
- Testing
- contezolid acefosamil, linezolid 600 mg
- Where
- 7 sites in United States
- Volunteers
- 196 people
- Sponsor
- MicuRx
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)
Anthrax
BARDA Securing Anthrax Immunity For the Elderly
This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable…
- Trial name
- B-SAFE (NCT03518125)
- Testing
- BioThrax, AV7909
- Where
- 4 sites in United States
- Volunteers
- 305 people, healthy volunteers welcome
- Sponsor
- Biomedical Advanced Research and Development Authority
Gram-Positive Bacterial Infections
A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)
This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a single IV (Part A) or oral suspension (Part B)…
- Trial name
- NCT02750761
- Testing
- Tedizolid Phosphate (IV), Tedizolid Phosphate (oral suspension)
- Volunteers
- 32 people
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Gram-Positive Bacterial, Abscess
Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria.
- Conditions
- Infections, Gram-Positive Bacterial, Abscess, Burns, Cellulitis
- Trial name
- FAST (NCT00061633)
- Testing
- Telavancin, Vancomycin or antistaphylococcal penicillin
- Where
- United States
- Volunteers
- 169 people
- Sponsor
- Cumberland Pharmaceuticals
Gram-Positive Bacterial Infections
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.
- Trial name
- ASSURE (NCT00062647)
- Testing
- Telavancin, Vancomycin, nafcillin, oxacillin, or cloxacillin
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Cumberland Pharmaceuticals
Infections, Gram-positive Bacterial
Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to…
- Trial name
- FAST2 (NCT00077675)
- Testing
- Telavancin, vancomycin or antistaphylococcal penicillin
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Cumberland Pharmaceuticals
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
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.
- Trial name
- NCT00633152
- Testing
- ceftaroline, linezolid, Aztreonam
- Where
- 13 sites in United States
- Volunteers
- 150 people
- Sponsor
- Forest Laboratories
Streptococcal Infections, Gram-Positive Bacterial Infections
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring.
- Conditions
- Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
- Trial name
- NCT01412801
- Testing
- Group B streptococcus vaccine
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 270 people
- Sponsor
- Novartis Vaccines
Streptococcal Infection, Gram-positive Bacterial Infection
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
- Conditions
- Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
- Trial name
- NCT01446289
- Testing
- Group B Streptococcus Trivalent Vaccine
- Where
- 5 sites in Belgium, Canada
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Novartis
Bacteremia, Gram-Positive Bacterial Infections
Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
- Trial name
- NCT00108433
- Testing
- Cefazolin IV, Linezolid IV, Vancomycin (IV)
- Where
- 17 sites in United States, Colombia and 5 more
- Volunteers
- 61 people
- Sponsor
- Pfizer
Gram-Positive Bacterial Infections
Post Marketing Surveillance Study on Linezolid
The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.
- Trial name
- A5951090 (NCT01564758)
- Testing
- Linezolid
- Volunteers
- 99 people
- Sponsor
- Pfizer
Fever, Neutropenia
A Study of Ceftobiprole in Patients With Fever and Neutropenia.
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in patients with fever and neutropenia
- Conditions
- Fever, Neutropenia, Gram-positive Bacterial Infections, Pseudomonas Infection
- Trial name
- NCT00529282
- Testing
- Ceftobiprole Medocaril, Cefepime with or without vancomycin
- Volunteers
- 2 people
- Sponsor
- Basilea Pharmaceutica