Condition category
Infections and Infestations
Date applied
17/06/2020
Date assigned
19/06/2020
Last edited
19/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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
hhgbaguidihaore@chu-besancon.fr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Houssein Gbaguidi-Haore

ORCID ID

http://orcid.org/0000-0002-1825-9358

Contact details

3 Bd Fleming
Besançon
25030
France
+33 3 70 63 21 37
hhgbaguidihaore@chu-besancon.fr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2011-A01013-38

Study information

Scientific title

Do contact precautions reduce the incidence of ICU-acquired Pseudomonas aeruginosa infections? The DPCPYO cluster-randomised crossover trial

Acronym

DPCPYO

Study hypothesis

To evaluate the benefits of contact precautions over standard precautions for reducing the incidence of ICU-acquired Pseudomonas aeruginosa infections

Ethics approval

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; cpp@chu-besancon.fr), ref: 2011-A01013-38

Study design

Multicentre cluster-randomised crossover trial

Primary study design

Interventional

Secondary study design

Cluster-randomised crossover trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prevention of ICU-acquired Pseudomonas aeruginosa infections

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

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

16/05/2011

Overall trial end date

31/12/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Adult (> 15-year old patients) admitted for more than 24 hours in ICU

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

5000 patients from 10 ICUs from 6 university hospitals

Total final enrolment

3283

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2012

Recruitment end date

26/06/2014

Locations

Countries of recruitment

France

Trial participating centre

University Hospital of Besançon - Jean MINJOZ
3 Bd Fleming
Besançon
25030
France

Sponsor information

Organisation

Centre Hospitalier Universitaire de Besançon

Sponsor details

2 Place Saint-Jacques
Besançon
25030
France
+33 3 81 66 81 66
recherche@chu-besancon.fr

Sponsor type

Hospital/treatment centre

Website

http://www.chu-besancon.fr/

Funders

Funder type

Government

Funder name

French Ministry of Health - PHRC national 2011

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

30/07/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/06/2020: Trial’s existence confirmed by Comité de protection des personnes (CPP)