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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40372159

Enrollment

Registered

2009-04-20

Start date

2002-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis in intensive care unit Infections and Infestations Candidiasis

Interventions

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, th

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Evaluation of fungal flora and candidemia, assessed weekly for 4 weeks.	—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026