Effects of digestive decontamination by amphotericine B on Candida colonisation and on the risk of invasive candidiasis in a surgical intensive care unit
| ISRCTN | ISRCTN40372159 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40372159 |
| Protocol serial number | AFSSAPS ref: 021284 |
| Sponsor | University Hospital of Dijon (CHU de Dijon) (France) |
| Funder | University Hospital of Dijon (CHU de Dijon) (France) |
- Submission date
- 11/02/2009
- Registration date
- 20/04/2009
- Last edited
- 20/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nadine Milesi
Scientific
Scientific
CHU de Dijon
3 Rue du Faubourg Raines
Dijon
21033 Cedex
France
| nadine.milesi@chu-dijon.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | DECONTAM |
| Study objectives | Interest of oral amphotericin B in prevention of candida contamination. |
| Ethics approval(s) | University Hospital of Dijon (CHU Dijon), approved on 24/09/2002 (ref: 2002/18) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Amphotericin B |
| Primary outcome measure(s) |
Percentage of patients with Candida colonisation index (CI) >0.5, assessed weekly for 4 weeks. |
| Key secondary outcome measure(s) |
Evaluation of fungal flora and candidemia, assessed weekly for 4 weeks. |
| Completion date | 01/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key exclusion criteria | Minor patients and patients for whom we had not collected their assent or of their family. |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 01/08/2003 |
Locations
Countries of recruitment
- France
Study participating centre
CHU de Dijon
Dijon
21033 Cedex
France
21033 Cedex
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
