Ecological Effects of Decolonisation Strategies in Intensive Care

• Status: Completed
• Trial end date: 2017-10-27
• Target enrollment: 0
• Participant gender: All

Summary

Previous research has shown that applying certain treatments can reduce both the number of infections and the presence of resistant bacteria in the intensive care (ICU) and its patients. These treatments have been used as standard care throughout the world for many years, but they have not been compared to each other yet. The investigators aim to evaluate the effect of 3 different treatments on the occurrence of resistant bacteria and bacterial infections in the ICU and to establish which treatment is the best.

All adult patients undergoing mechanical ventilation are eligible for this study and will receive treatment according to the study scheme. Twice weekly, sputum and rectal samples will be obtained to measure the effects.

All ICU-patients will receive standard treatment, consisting of daily body washing with an antiseptic (chlorhexidine 2%), oral care and a hand-hygiene program for health care workers as endorsed by the WHO. According to 4 different study periods, each participant will receive one of the following extra treatments depending on his or her admission date:

• Standard treatment only (this is the control group)

• Chlorhexidine 1% oral gel, this is an antiseptic.

• Antibiotic mouth paste containing 3 different antibiotics (selective oropharyngeal decontamination, SOD).

• Antibiotic mouth paste and suspension for the stomach and intestines containing 3 different antibiotics (selective digestive decontamination, SDD).

All treatments will be given 4 times daily with the purpose of killing harmful bacteria in the mouth (CHX, SOD,SDD) and digestive tract (SDD).

During the study the investigators will examine the effect of these treatments on:

• the occurrence of blood stream infections with certain bacteria

• cross-transmission of certain bacteria between patients

• presence of these bacteria in the respiratory tract of the patients

• patient survival

Benefits: Previous research has shown that these interventions can reduce infections in intensive care patients.

Risks: The interventions performed (both cultures and treatment) are considered safe and are already given as standard care in many ICUs throughout the world. There is a slight risk that bacteria become resistant to antibiotics: this will be monitored closely during the trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MJM Bonten
• Collaborator: Paris 12 Val de Marne University
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Colistin; Nystatin; Tobramycin

Criteria

Inclusion Criteria:

• mechanical ventilation (only invasive ventilation: i.e. intubated patients or patients with tracheostomal ventilation)

• no planned extubation within 24 hours When mechanical ventilation is not started directly after admission but later in the course of their ICU stay, patients are still eligible to participate.

Exclusion Criteria:

• patients under the age of 18

• patients with known allergy to any of the medications or agents used (i.e. colistin, tobramycin, nystatin or chlorhexidine )

• pregnancy

Participation ends as soon as the patient is extubated or after tracheostomal ventilation has stopped (weaning completed).