Clinical Trials Logo
  1. Home
  2. Pneumonia, Ventilator-Associated
  3. NCT02940626

Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.

Pneumonia, Ventilator-associated Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus Aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects

Clinical Trial Summary

The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

Clinical Trial Description

This is a double-blind, randomized, single-dose, placebo-controlled study of ASN100 for the prevention of S. aureus pneumonia in mechanically ventilated subjects who are heavily colonized with S. aureus. This will be a global study conducted at approximately 65 sites to assess the safety, tolerability, and efficacy of ASN100.

Eligible subjects who meet all of the inclusion criteria and none of the exclusion criteria will be screened by semi-quantitative culture of an endotracheal aspirate (ETA) to identify those who are heavily colonized with S. aureus (3+ to 4+). Upon determination of eligibility, subjects will be randomized in a 1:1 ratio to 1 of 2 treatment groups, ASN100 or placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02940626
Study type Interventional
Source Arsanis, Inc.
Contact
Status Terminated
Phase Phase 2
Start date November 2016
Completion date September 28, 2018
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06370598 - Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia Phase 1/Phase 2
Terminated NCT02806141 - Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates Phase 3
Completed NCT01765530 - Efficacy Study of a Novel Device to Clean the Endotracheal Tube N/A
Completed NCT00521677 - Comparison Between Two Methods of Oral Care on the Incidence of VAP N/A
Completed NCT00529776 - Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy N/A
Completed NCT03401463 - Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar N/A
Completed NCT02950519 - Endotracheal Tube Cuff Pressures in Ventilated Patients N/A
Completed NCT01875692 - Can we Better Understand the Development of VAP and Eventually Predict and Prevent it? N/A
Completed NCT00515034 - A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia Phase 2
Recruiting NCT05117125 - Biomarkers for Ventilator-associated Pneumonia
Completed NCT04755972 - Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2 N/A
Completed NCT01577862 - Colistin and Rifampicin for MDR-Acinetobacter Phase 3
Completed NCT00572559 - Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus Phase 4
Not yet recruiting NCT04566172 - Preoperative Optimization to Improve Functional Status N/A
Recruiting NCT04215692 - Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients N/A
Completed NCT03816956 - Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 Phase 3
Active, not recruiting NCT01123681 - Intubation and Extubation Over 48 Hours Mechanical Ventilation N/A
Recruiting NCT04839653 - Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria N/A
Recruiting NCT03527992 - Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia N/A
Recruiting NCT05405491 - Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation N/A