Dosing and safety of amphotericin B deoxycholate in paediatric American cutaneous leishmaniasis in Peru: a case series.

BACKGROUND

Cutaneous leishmaniasis (CL) is a parasitic disease endemic to the Americas, with a high prevalence in Peru. In resource-limited settings where liposomal amphotericin B is often unavailable, amphotericin B deoxycholate (AmB-d) remains a second-line option. However, data on its safety and effectiveness in children are scarce. This study describes the clinical experience of 20 paediatric patients with CL treated with AmB-d in a referral centre in Peru.

METHODS

We conducted a retrospective descriptive study of patients ≤14 years with confirmed localised CL who had failed parental sodium stibogluconate (Sb5+ IM/IV) treatment and received intravenous AmB-d at Hospital Cayetano Heredia (Peru) between January 2000 and December 2007. Patients received daily treatment until all lesions met the early cure criteria, defined as complete reepithelialization at the time of discharge. We collected demographic, clinical, and laboratory data, including the mean daily dose, cumulative dose, and adverse events (AEs).

RESULTS

We included 20 patients with a mean age of 4.9 years (±3.7), and 90% had lesions on the face. Nineteen patients (95%) completed treatment and achieved early clinical cure. Mean cumulative dose was 19.8 mg/kg (±5.7) and mean treatment duration was 28.8 days (±7.1). A total of 63.2% (12/19) of patients achieved clinical cure with a cumulative dose below 20mg/kg, and 84.2% with a dose below 25 mg/kg. Systemic adverse events (AEs), including fever (90%) and anorexia (70%), occurred mainly between the second and third weeks of treatment (83%). Six patients (30%) developed an increase in serum creatinine and nine (45%) developed hypokalemia.

CONCLUSIONS

Intravenous amphotericin B deoxycholate (AmB-d) is an effective and well-tolerated second-line treatment for paediatric American CL unresponsive to Sb5+ treatment. Despite the need for high cumulative doses, prolonged treatment durations, and frequent AEs, side effects were mild to moderate, transient, and did not lead to treatment discontinuation.