Amphotericin B therapy in children with visceral leishmaniasis: daily vs. alternate day, a randomized trial
Utpal Kant Singh1, Rajniti Prasad, Bir Prakash Jaiswal
1Department of Pediatrics and Child Care Center, Nalanda Medical College, Patna 800016, Bihar, India. utpalkant.singh@yahoo.co.in
Insights
Daily amphotericin B is as effective and safe as alternate-day dosing for treating childhood visceral leishmaniasis (VL). This daily regimen offers a more cost-effective treatment option with shorter hospital stays for VL patients.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Visceral leishmaniasis (VL) is a serious parasitic disease affecting children.
- Current treatment guidelines often recommend alternate-day amphotericin B regimens.
- Optimizing amphotericin B administration is crucial for improving patient outcomes and reducing healthcare costs.
Purpose of the Study:
- To compare the efficacy and safety of daily versus alternate-day amphotericin B in pediatric visceral leishmaniasis.
- To evaluate treatment costs and duration of hospital stay associated with different amphotericin B dosing schedules.
- To determine the optimal dosing strategy for amphotericin B in children with VL.
Main Methods:
- A randomized controlled trial involving 605 children under 14 years with VL.
- Group A received amphotericin B (1 mg/kg/day) daily for 15 days.
- Group B received the same dose on alternate days.
Main Results:
- All patients completing therapy in both groups achieved a cure.
- No relapses were observed at 1 and 6 months post-treatment.
- Adverse reactions were not significantly different between the daily and alternate-day groups.
- Daily dosing led to significantly shorter hospital stays and lower therapy costs.
- Higher rates of patients leaving against medical advice were noted in the alternate-day group.
Conclusions:
- Daily amphotericin B is an equally effective and well-tolerated treatment for pediatric visceral leishmaniasis compared to alternate-day dosing.
- The daily regimen is more cost-effective and associated with reduced hospital stays.
- Daily administration of amphotericin B is a viable and potentially superior alternative to the current alternate-day practice for VL treatment in children.
Abstract:
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.
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