Ecological Effects of Decolonisation Strategies in Intensive Care

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.

Conditions

• ICU-ecology (Multidrug Resistant Bacteria)
• ICU-acquired Bacteraemia

Interventions

DRUG

Chlorhexidine oral care (CHX-Oro)

Oromucosal gel consisting of chlorhexidine 1%, administered 4 times daily.

DRUG

Selective oropharyngeal decontamination (SOD)

SOD consists of application of a paste containing colistin, tobramycin in a 2% concentration and nystatin 1 x 10\^5 units. SOD will be applied to the mouth 4 times daily until extubation.

DRUG

Selective Digestive Decontamination (SDD)

SDD consists of both: * SOD (described elsewhere) * AND 10 ml of an enteric suspension containing 100 mg colistin, 80 mg tobramycin and nystatin 2 x 10\^6 i.u, to be administered via the nasogastric tube. The combination is administered 4 times daily (Unlike in previous studies, systemic antibiotics are not a part of SDD)

Sponsors & Collaborators

• Paris 12 Val de Marne University

  collaborator OTHER

• MJM Bonten

  lead OTHER

Principal Investigators

• Marc JM Bonten, Prof. · UMC Utrecht

• Christian Brun-Buisson, Prof. · UPEC Paris

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-01

Primary Completion

2017-10-27

Completion

2017-10-27

Countries

• Belgium
• Italy
• Portugal
• Slovenia
• Spain
• United Kingdom

Study Locations