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
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