Impact of contact precautions for preventing bacterial (Pseudomonas aeruginosa) infections in intensive care units
| ISRCTN | ISRCTN92710225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92710225 |
| Secondary identifying numbers | 2011-A01013-38 |
- Submission date
- 17/06/2020
- Registration date
- 19/06/2020
- Last edited
- 03/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Scientific
3 Bd Fleming
Besançon
25030
France
 ORCID ID |
0000-0002-1825-9358 |
|---|---|
| Phone | +33 3 70 63 21 37 |
| hhgbaguidihaore@chu-besancon.fr |
Study information
| Study design | Multicentre cluster-randomised crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster-randomised crossover trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Do contact precautions reduce the incidence of ICU-acquired Pseudomonas aeruginosa infections? The DPCPYO cluster-randomised crossover trial |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 16/05/2011 |
| Overall study end date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 5000 patients from 10 ICUs from 6 university hospitals |
| Total final enrolment | 3283 |
| Participant inclusion criteria | Adult (> 15-year old patients) admitted for more than 24 hours in ICU |
| 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
Study participating centre
Besançon
25030
France
Sponsor information
Hospital/treatment centre
2 Place Saint-Jacques
Besançon
25030
France
| Phone | +33 3 81 66 81 66 |
|---|---|
| recherche@chu-besancon.fr | |
| Website | http://www.chu-besancon.fr/ |
"ROR" |
https://ror.org/0084te143 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during the current study will be available after de-identification, from 6 months and until 24 months after the article publication, upon request to Dr Houssein Gbaguidi-Haore (hhgbaguidihaore@chu-besancon.fr) by providing a research project proposal and after signing a data access agreement. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/11/2020 | 03/11/2020 | Yes | No |
Editorial Notes
03/11/2020: Publication reference and IPD sharing statement added.
19/06/2020: Trial’s existence confirmed by Comité de protection des personnes (CPP)
