Amphotericin B therapy in children with visceral leishmaniasis: daily vs. alternate day, a randomized trial.

A randomized study was carried out to compare the efficacy and adverse reactions of daily vs. alternate day regimens of amphotericin B in children with visceral leishmaniasis (VL). Six hundred and five children of VL below 14 years of age were randomized into two groups; Group A (302), who received amphotericin B at a dose of 1 mg kg(-1) day(-1) for 15 days and Group B (303); same doses but on alternate days. All patients in both groups were cured, who had completed course of amphotericin B therapy. None had relapsed at 1 and 6 months of follow-up. Adverse reactions in both groups were non-significant. The duration of stay and cost of therapy was significantly lower in Group A children who left the hospital against medical advice, which was also significantly more in Group B. Thus, daily regimen of amphotericin B is equally effective, well tolerated, not more toxic and cost-effective than alternate day regimen, which is currently practiced.

RCT Entities:   Population Interventions Outcomes