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 |
| Secondary identifying numbers | AFSSAPS ref: 021284 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amphotericin B |
| Primary outcome measure | 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 study start date | 01/11/2002 |
| Completion date | 01/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
Sponsor information
University Hospital of Dijon (CHU de Dijon) (France)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Nadine Milesi
3 Rue du Faubourg Raines
Dijon
21033 Cedex
France
| nadine.milesi@chu-dijon.fr | |
| Website | http://www.chu-dijon.fr/ |
"ROR" |
https://ror.org/0377z4z10 |
Funders
Funder type
Hospital/treatment centre
University Hospital of Dijon (CHU de Dijon) (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
