Condition category
Infections and Infestations
Date applied
11/02/2009
Date assigned
20/04/2009
Last edited
20/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nadine Milesi

ORCID ID

Contact details

CHU de Dijon
3 Rue du Faubourg Raines
Dijon
21033 Cedex
France
nadine.milesi@chu-dijon.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AFSSAPS ref: 021284

Study information

Scientific title

Effects of digestive decontamination by amphotericine B on Candida colonisation and on the risk of invasive candidiasis in a surgical intensive care unit: a prospective randomised study

Acronym

DECONTAM

Study hypothesis

Interest of oral amphotericin B in prevention of candida contamination.

Ethics approval

University Hospital of Dijon (CHU Dijon), approved on 24/09/2002 (ref: 2002/18)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Candidiasis in intensive care unit

Intervention

Amphotericine B (oral) versus placebo.

Patients in group 1 received, from inclusion in the study, a measuring-spoonful of amphotericine B 10% (1 measuring spoonful = 15 ml), drinkable solution, three times a day along with a mouthwash with the same solution. Patients in group 2 received the placebo, conditioned the same way than amphotericine B, at the same moment and frequency. The treatment was continued during the hospitalisation. It was interrupted and replaced by a curative treatment of fluconazole for 21 days if the Candida colonisation index became higher than 0.5. The does of fluconazole was 800 mg intravenously (IV) on the first day and then 400 mg IV for 14 days or longer (if colonisation persisted or candidemia appeared). This treatment was readjusted for the second time following the data of the antifungigram.

The patients were monitored during four weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Amphotericin B

Primary outcome measures

Percentage of patients with Candida colonisation index (CI) >0.5, assessed weekly for 4 weeks.

Secondary outcome measures

Evaluation of fungal flora and candidemia, assessed weekly for 4 weeks.

Overall trial start date

01/11/2002

Overall trial end date

01/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, no age limits
2. Patients hospitalised in a surgical intensive care unit with severe head trauma (Glasgow Coma Scale <8), heavy abdominal surgery or traumatic post-operative abdomen
3. Patients who have recently started a prolonged antibiotherapy
4. Long lasting hospitalisation in a intensive care unit
5. Screening candiduria above 10^4 colony forming units (cfu)/ml

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

40

Participant exclusion criteria

Minor patients and patients for whom we had not collected their assent or of their family.

Recruitment start date

01/11/2002

Recruitment end date

01/08/2003

Locations

Countries of recruitment

France

Trial participating centre

CHU de Dijon
Dijon
21033 Cedex
France

Sponsor information

Organisation

University Hospital of Dijon (CHU de Dijon) (France)

Sponsor details

c/o Dr Nadine Milesi
3 Rue du Faubourg Raines
Dijon
21033 Cedex
France
nadine.milesi@chu-dijon.fr

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Dijon (CHU de Dijon) (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes