Treatment Of Indian Visceral Leishmaniasis With Single Or Daily Infusions Of Low Dose Liposomal Amphotericin B: Randomised Trial

Objective To test short course, low dose liposomal amphotericin B as single or daily infusion treatment in Indian visceral leishmaniasis (kala-azar). Design Randomised, open label study. Setting Inpatient unit for leishmaniasis in Bihar, India. Participants 91 adults and children with splenic aspira...

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Published inBMJ (Online) Vol. 323; no. 7310; pp. 419 - 422
Main Authors Sundar, Shyam, Agrawal, G., Rai, Madhukar, Makharia, M. K., Murray, Henry W.
Format Journal Article
LanguageEnglish
Published London British Medical Association 25.08.2001
BMJ Publishing Group Ltd
BMJ Group
Subjects
Adolescent
Adult
Amphotericin B
Amphotericin B - administration & dosage
Amphotericin B - adverse effects
Amphotericin B - therapeutic use
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antimony
Antiparasitic agents
Antiprotozoal Agents - administration & dosage
Antiprotozoal Agents - adverse effects
Antiprotozoal Agents - therapeutic use
Biological and medical sciences
Child
Dosage
Dosage and administration
Drug Administration Schedule
Experimentation
Female
Fever
Humans
Infusions, Intravenous
Kala-azar
Leishmaniasis, Visceral - drug therapy
Lipids
Liposomes
Male
Medical cures
Medical sciences
Parasites
Pharmacology. Drug treatments
Pilot Projects
Recurrence
Relapse
Symptoms
Treatment Outcome
Tropical medicine
Visceral leishmaniasis
Asia
India
United Kingdom
Kinetoplastida
Human
Protozoa
Protozoal disease
Low dose
Leishmania donovani
Single dose
Kala azar
Leishmaniasis
Parasitosis
Infection
Chemotherapy
Treatment
Amphotericin B
Polyenic compound
Parasiticid
Daily dose
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Summary:Objective To test short course, low dose liposomal amphotericin B as single or daily infusion treatment in Indian visceral leishmaniasis (kala-azar). Design Randomised, open label study. Setting Inpatient unit for leishmaniasis in Bihar, India. Participants 91 adults and children with splenic aspirate positive for infection. Interventions Total dose of 5 mg/kg of liposomal amphotericin B given as a single infusion (n = 46) or as once daily infusions of 1 mg/kg for five days (n = 45). Main outcome measures Clinical and parasitological cure assessed 14 days after treatment and long term definitive cure (healthy, no replase) at six months. Results All but one person in each group had an initial apparent cure. During six months of follow up, three patients in the single dose group and two in the five dose group relapsed. Complete response (definitive cure) was therefore achieved in 84 of 91 subjects (92%): 42 of 46 patients in the single dose group (91%, 95% confidence interval 79% to 98%) and 42 of 45 in the five dose group (93%, 82% to 99%). Response rates in the two groups were not significantly different. Conclusion Low dose liposomal amphotericin B (5 mg/kg), given either as a five day course or as a single infusion, seems to be effective for visceral leishmaniasis and warrants further testing.
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Correspondence to: S Sundar shyams_vns@satyam.net.in
Contributors: SS participated in designing the study, collecting the data, and writing the paper and was the principal investigator, He is guarantor of the paper. GA, MR, and MKM were involved in clinical assessment of patients and collecting data. HWM collaborated on the design of the study, was responsible for interpreting data, and helped with writing the paper.
ISSN:0959-8138
0959-8146
1756-1833
1468-5833
DOI:10.1136/bmj.323.7310.419