Clinical trials: Acinetobacter Baumannii Infection
Acinetobacter Baumannii Infection
Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects
This research project is being conducted to look at the pharmacokinetics (PK; how the human body processes a substance), safety, and tolerability of a single dose of ETX2514 and sulbactam (ETX2514SUL) when concurrently…
- Trial name
- NCT03310463
- Testing
- ETX2514SUL
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Ventilator Associated Pneumonia
PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
A multicenter Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B in adult patients with VABP suspected or confirmed to be due to CRAB
- Trial name
- NCT05685615
- Testing
- BV100 plus Polymyxin B, BAT
- Where
- 16 sites in Georgia, Greece and 1 more
- Volunteers
- 39 people
- Sponsor
- BioVersys AG
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including anaphylaxis) in participants with Acinetobacter baumannii-calcoaceticus complex…
- Trial name
- NCT06746883
- Testing
- Non-interventional
- Where
- 12 sites in United States
- Volunteers
- 100 people
- Sponsor
- Innoviva Specialty Therapeutics
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
The goal of this clinical trial is to investigate the use of Sulbactam-Durlobactam (SUL-DUR) in pediatric patients and is being conducted to collect pharmacokinetic (PK) and safety data to enable the identification of appropriate…
- Trial name
- NCT06801223
- Testing
- Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours), Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours)
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- Innoviva Specialty Therapeutics
Bacteremia
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
- Trial name
- DIREBT (NCT01919762)
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- T2 Biosystems
Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP)
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections.
- Conditions
- Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP), Blood Stream Infection, Meningitis, Bacterial
- Trial name
- RIV- CARE (NCT07431307)
- Testing
- BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT)
- Volunteers
- 120 people
- Sponsor
- BioVersys AG
Carbapenem-Resistant Enterobacteriaceae
Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase…
- Trial name
- NCT03680898
- Testing
- Rectal swab collection
- Where
- 3 sites in United States, Canada
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
Acinetobacter Baumannii Infection
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects
This research project is being conducted to look at the safety, tolerability, and pharmacokinetics (PK; how the human body processes a substance) of ETX2514 when given to healthy volunteers intravenously as a single dose, and…
- Trial name
- NCT02971423
- Testing
- ETX2514, Sulbactam, Imipenem/Cilastatin
- Where
- Australia
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Acinetobacter Baumannii-calcoaceticus Complex Infections
Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects
This study will be conducted to determine the routes and rates of excretion of radio label arising from 14C-ETX2514 and to characterize metabolites of ETX2514 arising from 14C-ETX2514 administered intravenously in healthy…
- Trial name
- NCT04018950
- Testing
- ETX2514, 14C-ETX2514
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Acinetobacter Baumannii-calcoaceticus Complex Infections
Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers
This study is being conducted to evaluate the effects of supratherapeutic ETX2514 plasma concentrations on the heart rate-corrected QT interval (QTc).
- Trial name
- NCT03985410
- Testing
- ETX2514, moxifloxacin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Gram-Negative Bacterial Infections
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae…
- Trial name
- NCT00079989
- Testing
- tigecycline
- Volunteers
- 115 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Covid19, Bacteremia
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
Phage Treatment in Covid-19 Patients with Bacterial Co-Infections
- Conditions
- Covid19, Bacteremia, Septicemia, Acinetobacter Baumannii Infection
- Trial name
- NCT04636554
- Testing
- Phage Therapy
- Sponsor
- Adaptive Phage Therapeutics, Inc.