Optimal Antibiotic Treatment of Moderate to Severe Bacterial Infections

Status Completed

Clinical Trial Summary

Severe bacterial infections are associated with mortality of about 30%. Patients with moderate to severe bacterial infections given early and appropriate empirical antibiotic treatment are at a lesser risk for a fatal outcome, with odds ratios ranging from 1.6 to 6.9. However only about 2/3 of patients worldwide are given early and appropriate empirical antibiotic treatment. About 40% of patients treated with antibiotics are given superfluous treatment. TREAT is a computerized decision support system for antibiotic treatment in inpatients with common bacterial infections. TREAT is based on a state of the art stochastic model of the domain (a causal probabilistic network) and uses a cost benefit model for antibiotic treatment, including costs assigned to future resistance. It was tested in a randomized controlled trial in 3 countries and shown to improve the percentage of appropriate empirical antibiotic treatment while at the same time reduce hospital stay and the use of broad-spectrum antibiotics. The main limitation of TREAT is inherent in the limited information available within hours of presentation. A second attractive approach to improve antibiotic treatment is to use techniques that do not depend on cultures, and thus shorten the time to identification of the pathogen to a few hours only. The LightCycler® SeptiFast test from Roche performs in vitro nucleic acid amplification test for pathogens causing bloodstream infections. The purpose of the clinical trial is to show that the combined system TREAT/PCR assays will improve the outcome of inpatients with moderate to severe bacterial infections, while at the same time reducing the use of broad-spectrum antibiotics, with no or little additional costs. A secondary objective will be to assess the sensitivity and specificity of whole blood PCR, using TREAT as the reference standard.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01338116
Study type	Interventional
Source	Rabin Medical Center
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	May 13, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT01535170` - Bovine Lactoferrin as a Natural Regimen of Selective Decontamination of the Digestive Tract in Patients With Prolonged Mechanical Ventilation	N/A
Completed	`NCT01678612` - Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit	N/A
Completed	`NCT04748432` - Lipid Kinetics of Patients With Pneumonia
Completed	`NCT02600195` - Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality	N/A
Completed	`NCT00787345` - Simulation-based Training for Surgery Residents in Aseptic Techniques	Phase 3
Completed	`NCT00791583` - ED Residents MBP During CVC Placement: Sim Lab Based Training	N/A
Completed	`NCT00113191` - Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants	N/A
Recruiting	`NCT00843804` - Surveillance for Nosocomial Infections in Pediatric Cancer Patients	N/A
Recruiting	`NCT00854633` - Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants	Phase 1/Phase 2
Completed	`NCT00122057` - Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis	N/A
Completed	`NCT00617006` - Potential Nosocomial Infection Prevention Via Modification of Anesthesia Intraoperative Aseptic Practice	N/A
Recruiting	`NCT04775238` - Effect of Metallic Nanoparticles on Nosocomial Bacteria	N/A
Completed	`NCT00549393` - Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit	Phase 2/Phase 3
Completed	`NCT00151606` - Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.	N/A
Completed	`NCT01346735` - Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)	N/A
Completed	`NCT02756351` - A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Optimal Antibiotic Treatment of Moderate to Severe Bacterial Infections — CDSS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms