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Safety of liposomal amphotericin as a once-weekly antifungal prophylactic regimen in very low birth-weight premature infants

Abstract number: P1035

Arrieta A.C., Shea K., Dhar V., Cleary J., Kukreja S., Ashouri N., Singh J.

Objectives:Candida infections are a common cause of morbidity and mortality among very low birth weight (VLBW) infants. Several studies have shown that prophylaxis may decrease the incidence of candidiasis and improve survival. At a rate of 2.6/1000 patient days, a large number of infants will be exposed to drug to prevent one infection. The safety of a prophylactic drug then needs to be exhaustively evaluated. We studied the safety of liposomal amphotaricin B (L-AmB) given once weekly at a 5 mg/kg dose as a prophylactic regimen to prevent Candida colonisation and invasive infection in VLBW < 6 weeks of age.

Methods: Premature newborns < 32 weeks gestation; <1500 g birth weight; < 7 days of life were eligible. Subjects were randomised to receive L-AmB 5 mg/kg once a week or placebo (dextrose in water). L-AmB trough level was obtained on day 7. Surveillance cultures were obtained at baseline, 72 hours later and then weekly from rectum, axillae and respiratory tract. Study drug was continued until no risk factors (antibiotics, central vascular access, hyperalimentation, endotracheal intubation) were present or 6 weeks of life which ever was earlier. Blood cultures were obtained as clinically indicated. Electrolytes, renal and liver function, as well as mortality and incidence of necrotising enterocolitis (NEC) and intraventricular haemorrhage (IVH) were monitored for safety.

Results: Twenty subjects were enrolled in to each study arm, demographic features and risk factors were evenly distributed. Steroids were used in 40% and 15% of L-AmB and placebo arms repectively. While on study, 5% on L-Amb and 15% on placebo arm developed colonisation; one subject on placebo developed invasive disease. One patient in each group died due to complications of prematurity. There was no significant difference in the incidence of IVH (grade III-IV), NEC or in the need for platelets, packed red blood cells and potasium supplementation. Renal and liver function changes were similar in both groups and of no clinical or statistical significance.

Conclusions: The safety of once weekly 5 mg/kg L-AmB in VLBW infants is supported by our trial and was comparable to placebo. Data from our pilot study suggests that a larger multi-centre trial is warranted

Session Details

Date: 19/04/2008
Time: 00:00-00:00
Session name: 18th European Congress of Clinical Microbiology and Infectious Diseases
Subject:
Location: Barcelona, Spain
Presentation type:
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