Plain English Summary
Background and study aims
In intensive care units (ICUs), the bacteria Pseudomonas aeruginosa is a major cause of healthcare-associated infections. The issue of physical contact precautions as contributory factors for reducing Pseudomonas aeruginosa infections in ICUs remains questioned.
We aimed to evaluate the benefit of the addition of contact precautions to standard precautions in P. aeruginosa-positive patients for reducing the risk of ICU-acquired P. aeruginosa infections.
Who can participate?
Adult (older than 15-year old) patients admitted for more than 24 hours in ICU
What does the study involve?
Ten French ICUs were randomly assigned to take additional precautions or standard precautions for 6 months, followed by a 3 month break, followed by 6 months using the other precautions to the first 6 months.
What are the possible benefits and risks of participating?
Minimal risk of adverse events
Where is the study run from?
University Hospital of Besançon (France)
When is the study starting and how long is it expected to run for?
May 2011 to December 2014
Who is funding the study?
This work was supported by the French Ministry of Health (PHRC national 2011)
Who is the main contact?
Dr Houssein Gbaguidi-Haore
Do contact precautions reduce the incidence of ICU-acquired Pseudomonas aeruginosa infections? The DPCPYO cluster-randomised crossover trial
To evaluate the benefits of contact precautions over standard precautions for reducing the incidence of ICU-acquired Pseudomonas aeruginosa infections
Approved 16/05/2011, The human research ethics committee of the Besançon University Hospital (Le comité de protection des personnes (CPP) - EST II, 2 Place Saint-Jacques, Besançon, France; +33 3 81 21 93 12; email@example.com), ref: 2011-A01013-38
Multicentre cluster-randomised crossover trial
Primary study design
Secondary study design
Cluster-randomised crossover trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Prevention of ICU-acquired Pseudomonas aeruginosa infections
Ten French ICUs were randomly assigned (1:1) to sequence 0-1 (6-month control period /3-month wash-out period/6-month intervention period) or sequence 1-0 (6-month intervention period/3-month wash-out period/6-month control period).
Intervention period (the addition of contact precautions to standard precautions) vs control period (standard precautions) for Pseudomonas aeruginosa-positive patients with a surveillance screening programme.
The interventions (contact precautions) are the systematic implementation of the following measures: placing in single room or cohorting, signalling on the door, wearing gown, appropriate hand hygiene at the exit of the patient room and prescribing of contact precautions in the medical record.
Primary outcome measure
Rate of ICU-acquired Pseudomonas aeruginosa infections measured using routine diagnostic samples (blood, bronchoalveolar lavage, urine…) with routine clinical surveillance of patients that remained unchanged throughout the study period. Patients were screened for P. aeruginosa carriage (throat swab/tracheal aspirate and rectal swab) upon ICU admission (≤ 48 h) and once a week thereafter.
Secondary outcome measures
1. Rate of Pseudomonas aeruginosa acquisition (acquired infection and/or colonisation) measured as above.
2. Clonal relatedness of P. aeruginosa isolates measured using the Simpson diversity index and transmission index of Pseudomonas aeruginosa isolates within ICUs throughout the study.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Adult (> 15-year old patients) admitted for more than 24 hours in ICU
Target number of participants
5000 patients from 10 ICUs from 6 university hospitals
Total final enrolment
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Hospital of Besançon - Jean MINJOZ
3 Bd Fleming
French Ministry of Health - PHRC national 2011
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)