Condition category
Infections and Infestations
Date applied
10/09/2015
Date assigned
15/09/2015
Last edited
15/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A central venous catheter (CVC) is a long, thin tube that is inserted into the major vein in the neck (jugular vein), chest (subclavian vein or axillary vein) or groin (femoral vein). CVC’s are considered to be one of the best ways to give long-term drug treatment, such as chemotherapy. The use of CVC’s has increased considerably in recent years and catheter-related bloodstream infections (CR-BSI) have become a recurrent complication. These infections can cause seriously ill patients with CVC’s to become even more ill or even die. It is thought that the amount of CR-BSI’s in hospitals is related to the way the catheters are inserted and cared for, as well as hand hygiene practices. The aim of this study is to find out whether applying new hand hygiene and CVC insertion and care programmes in hospitals can help to reduce the amount of CR-BSI’s.

Who can participate?
Adult patients with a CVC inserted in the hospital, on an ICU ward of a participating hospital.

What does the study involve?
In this study, each of the hospitals taking part is randomly allocated to take the different interventions (programmes) at different times. This means, that each hospital receives all of the different interventions though the course of the study. In a random order, each hospital implements their standard practices for CVC insertion and hand hygiene, the hand hygiene improvement programme, the CVC insertion and care programme or both of these programmes. Throughout the study, the number of CR-BSI’s are recorded every three months.

What are the possible benefits and risks of participating?
Participants are expected to benefit because improving hand hygiene practices and CVC insertion techniques, the chances of a CR-BSI will be lower. There are no risks of participating in the study.

Where is the study run from?
Fifteen hospitals in Europe.

When is the study starting and how long is it expected to run for?
December 2008 to June 2013

Who is funding the study?
Seventh Framework Programme (Belgium)

Who is the main contact?
Ms Tjallie van der Kooi
tjallie.van.der.kooi@rivm.nl

Trial website

https://plone.unige.ch/prohibit/

Contact information

Type

Scientific

Primary contact

Ms Tjallie van der Kooi

ORCID ID

http://orcid.org/0000-0002-5346-7224

Contact details

RIVM (National Institute for Public Health and the Environment)
Centre for Infectious Disease Control
Antonie van Leeuwenhoeklaan 9
Bilthoven
3721 MA
Netherlands
+31 30 2743395
tjallie.van.der.kooi@rivm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The PROHIBIT (PRevention Of Hospital Infections By Intervention and Training ) intervention study: a randomized multi-centre study in Intensive Care Units in Europe to reduce central venous catheter-related bloodstream infections (CRBSIs) by improving hand hygiene (HH) and central venous catheter (CVC) insertion and care, measuring both CRBSI incidence density and HH and CVC insertion compliance

Acronym

PROHIBIT WP5

Study hypothesis

To test the efficacy of a hand hygiene programme (World Health Organization (WHO)) and a CVC insertion and care programme (University Hospitals of Geneva), or both in improving prevention of central venous catheter (CVC)-related bloodstream infections (CRBSI) in the heterogeneous European setting.

Ethics approval

The Medical Ethics Review Committee of the University Medical Centre of Utrecht (Netherlands) concluded that ethics approval was not required, because the interventions consisted of best practice quality of care and patients did not receive a particular treatment, the Medical Research Involving Human Subjects Act (WMO) did not apply.

Local Ethics Approvals:
1. Austria: Ethics Committee of the Medical University Vienna, 04/10/2011
2. Belgium: Medical Ethics Committee of the AZ Sint Lucas hospital, 14/02/2010
3. Greece: Scientific and Ethics Committee of the Evaggelismos General Hospital: 17/01/2011
4. Hungary: Bácks-Kiskun county teaching hospital: Research Ethics Committee of the Szeged University: 30/03/2011
5. Hungary: Research Ethics Committee of the Szent János hospital, Budapest:: , 21/7/2011
6. Ireland: Clinical Research Ethics Committee of Galway University Hospitals: , 02/11/2010
7. Ireland: Ethics and Medical Research Committee of the St. Vincent's Healthcare group, Dublin, 17/01/2011
8. Italy: Committee of Bio-ethics of the Riuniti hospital of Bergamo, 02/11/2010
9. Latvia: Clinical Research Ethics Committee of the Paul Stradins Clinical University Hospital, 01/12/2010
10. Poland: Hospital of Silesia, Cieszyn: the Beskidzka Medical Doctors Association, 15/12/2011
11. Poland: Legal advisor of the John Paul II Regional Teaching Hospital, Kraków, 20/01/2011
12. Romania: Ethics Committee of the Institute for emergency cardiovascular diseases "Prof. C.C. Iliescu", 02/11/2010
13. Slovenia: Medical Ethics Committee of the Republic of Slovenia, 27/12/2010
14. Spain: Clinical Research Ethics Committee of the Vall d'Hebron University Hospital, 28/01/2011

Study design

Multi-centre randomized controlled stepped-wedge design

Primary study design

Interventional

Secondary study design

Randomized controlled stepped-wedge design

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Catheter-related bloodstream infections

Intervention

The cluster-randomized stepped wedge design allowed all centres to implement the intervention and to account for time-related changes. The baseline period functions as control period. Hospitals were randomized to receive one of the interventions described below (HH, CVC or BOTH). After a baseline of six months the first randomization took place: per intervention one hospital was randomly selected to start. After three months the second randomization round took place. There were in total 5 randomization rounds.

Control phase: Local practices regarding CVC insertion and hand hygiene are used.

Intervention phase: One or both of the following interventions were implemented:

Multimodal hand hygiene (HH) improvement programme (WHO):
1. System and infrastructure for HH (e.g. availability of hand alcohol at the bedside)
2. Training and education of healthcare workers
3. Evaluation and feedback to healtcare workers and management
4. Reminders in the workspace
5. Institutional safety climate

CVC insertion and care programme based on the University of Geneva Hospitals (HUG) catheter project:
1. Work organization
2. Patient preparation
3. Skin antisepsis
4. Maximal sterile barrier precautions
5. Catheter fixation and dressing
6. After insertion: evaluation of ongoing need of the catheter

After the start of the intervention hospitals would receive quarterly feedback reports on their CRBSI rates, HH compliance and/or CVC insertion compliance, depending on the intervention. Hospitals recorded their implementational activities throughout the study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Central venous catheter-related bloodstream infection (CRBSI) incidence density, measured as number of CRBSI per 1000 CVC days (CVC days of concurrent CVCdays were counted separately) every 3 months for 30 months.

Secondary outcome measures

1. Hand hygiene complianceias measured by direct observation using the well-known WHO “My five moments for hand hygiene” strategy (Sax et al, AJIC 2009) every 3 months for 30 months
2. Catheter insertion practice is measured by observing CVC insertions using a form based on the CRBSI prevention strategy of the University of Geneva Hospitals (Zingg et al, PloS one, 2014) every 3 months for 30 months

Overall trial start date

02/12/2008

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. ICU patients with CVCs in place for at least 24 hours
2. Aged 16 years or over

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

We aimed at including 15 centres: 5 per intervention, starting the intervention with 3 hospitals at the time, at 5 moments of time, 3 months apart. All hospitals collected data for 30 months. We expected that each hospital would contribute 10-15,000 CVC days per hospital per year.

Participant exclusion criteria

1. CVCs inserted outside the hospital
2. CVCs removed at the same day

Recruitment start date

01/01/2011

Recruitment end date

30/06/2013

Locations

Countries of recruitment

Austria, Belgium, Belize, Greece, Hungary, Ireland, Italy, Latvia, Poland, Romania, Slovenia, Spain

Trial participating centre

Allgemeines Krankenhaus Wien
Währinger Gürtel 18-20
Vienna 1
1090
Austria

Trial participating centre

AZ Sint-Lucas Gent
Groenebriel 1
Ghent
B-9000
Belgium

Trial participating centre

Evaggelismos Hospital
Ypsilandou str 45-47
Athens
10676
Greece

Trial participating centre

Bács-Kiskun County Teaching Hospital
38. Nyíri street
Kecskemét
6000
Hungary

Trial participating centre

Szent János Hospital
Gyali u. 2-6
Budapest
1097
Hungary

Trial participating centre

University College Hospital Galway
Newcastle Road
Galway
H91 YR71
Ireland

Trial participating centre

St. Vincent's University Hospital
Elm Park
Dublin
4
Ireland

Trial participating centre

Ospedali Riuniti / Ospedale Papa Giovanni XXIII
Piazza OMS - Organizzazione Mondiale della Sanità, 1
Bergamo
24127
Italy

Trial participating centre

Paul Stradins Clinical University Hospital
Pilsoņu str 13
Riga
1002
Latvia

Trial participating centre

John Paul II Regional Teaching Hospital
Prądnicka 80
Kraków
12 614 20 02
Poland

Trial participating centre

Hospital of Silesia
Bielska str 4
Cieszyn
43-400
Poland

Trial participating centre

Institute for emergency cardiovascular diseases "Prof. C.C. Iliescu"
Sos. Fundeni, Nr. 258
Bucharest
022322
Romania

Trial participating centre

University Medical Centre Ljubljana
Japljeva 2
Ljubljana
1000
Slovenia

Trial participating centre

Vall d'Hebron University Hospital
Passeig Vall d'Hebron 119-129
Barcelona
8035
Spain

Sponsor information

Organisation

National Institute for Public Health and the Environment (RIVM)

Sponsor details

Antonie van Leeuwenhoeklaan 9
Bilthoven
3721 MA
Netherlands
+31 30 2743395
tjallie.van.der.kooi@rivm.nl

Sponsor type

Government

Website

http://www.rivm.nl/en

Funders

Funder type

Not defined

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Publication through a peer-reviewed journal.
Further dissemination via congresses (ECCMID 2014, ICPIC 2013 and ICPIC 2015).

Intention to publish date

31/12/2015

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes