Comparación de la eficacia y toxicidad del estibogluconato de sodio y antimoniato de meglumina en el tratamiento de leishmaniasis cutánea en Perú / Efficacy and safety of sodium stibogluconate compared to meglumine antimoniate in the treatment of cutaneous leishmaniasis in Peru

Objetivos : Comparar la eficacia y toxicidad del antimoniato de meglumina (AM) y estibogluconato sódico (EGS) en el tratamiento de leishmaniasis cutánea (LC) en un hospital general. Material y métodos : Serie de casos comparativa de 193 pacientes con LC tratados en tres ensayos clínicos con AM (n=69) y EGS (n=124) durante 2001-2010. La administración de ambas drogas fue vía endovenosa lenta de 20 mg Sb5+/kg/día por 20 días consecutivos siguiendo las normativas de la OPS y OMS. La información clínica, toxicidad y eficacia fue obtenida de las historias clínicas almacenadas en el centro de investigación según la normativa local e internacional. Resultados : Las características demográficas fueron similares entre grupos, pero el tamaño y número de lesiones fueron mayores en el grupo AM. La eficacia del tratamiento con AM fue 76,0% versus 68,4% con EGS (p=0,340) y 55,1% versus 50,8% (p=0,570) en el análisis por protocolo y de intención de tratar, respectivamente. No se observaron efectos adversos inmediatos. Los síntomas más frecuentemente reportados fueron disgeusia (37,0%), mareos (32,0%), cefalea (36,0%), artralgias (31,0%) y linfangitis (21,0%). Los tres primeros síntomas, así como elevación de transaminasas, leucopenia, trombocitopenia y QTc prolongado fueron frecuentes en el grupo EGS, pero clínica y estadísticamente no significativos. El tratamiento fue suspendido definitivamente por toxicidad severa únicamente con EGS por emesis refractaria (2 participantes) y QTc prolongado con extrasístoles (1 participante). Conclusiones : La eficacia del tratamiento con AM y EGS fue comparable. La administración endovenosa de ambos no produjo efectos adversos inmediatos, aunque sí alteraciones clínicas y laboratoriales usuales.

SUMMARY Objectives : To compare the efficacy and safety of sodium stibogluconate (SS) and meglumine antimoniate (MA) in the treatment of cutaneous leishmaniasis (CL) in a general hospital. Methods: Case-series of 193 patients with CL treated in three clinical trials with MA (n=69) and SS (n=124) during 2001-2010. Both study drugs were administered intravenously at a slow speed at 20 mg Sb5+/kg/day for 20 consecutive days following WHO-PAHO recommendations. Clinical and safety data were gathered from clinical files. Results: Demographic characteristics were similar between the study groups, but the size and number of lesions were higher in the MA group. Efficacy was 76.0% in the MA vs. 68.4% in the SS group (p=0.340) and 55.1% vs. 50.8% (p=0.570) in the per protocol and intention to treat analysis. respectively. Side effects more frequently reported were dysgeusia (37.0%). dizziness (32.0%). headache (36.0%). arthralgia (31.0%) and lymphangitis (21.0%). These first three symptoms as well as elevation of transaminases, leukopenia, thrombocytopenia and prolonged QTc were numerically more frequent in the SS group but without reaching statistical significance. Treatment was stopped definitively for severe toxicity in the SS group due to refractory emesis (two patients) and prolonged QTc (one patient). Conclusions: The efficacy of MA and SS is comparable. The intravenous administration of these compounds did not produce immediate reactions, but it was associated with unusual clinical and laboratory abnormalities.

Leishmaniasis cutánea, a propósito de un caso / Cutaneous leishmaniasis, a purpose of a case

La Leishmaniasis es una enfermedad parasitaria catalogada como emer-gente y sin control debido al cambio en el perfil epidemiológico por el sur-gimiento de nuevos focos y urbanización del ciclo de transmisión. Se des-cribe el caso de un adolescente de la Comunidad Dos Ríos, del Cantón Taisha, quien presentó varias lesiones ulceradas, confirmándose diagnós-tico de Leishmaniasis Cutáneamediante estudio histológico, iniciándose tratamiento con sales de antimonio pentavalentes, logrando una resolución progresiva y paulatina de las lesiones. Destacándose la importancia del diagnóstico temprano, tratamiento supervisado, y seguimiento para preve-nir complicaciones.

Leishmaniasis is a parasitic, emergent and uncontrolled disease due to the change in the epidemiological profile for the appearance of new outbreaks and urbanization of the transmission cycle. A case of a 15-years-old ado-lescent, who is resident of the Community Dos Ríos located on the Taisha Canton, was described. The patient presented ulcerated lesions, confir-ming the diagnosis of Cutaneous Leishmaniasis through the histological study of the lesions, and starting intramuscular treatment with pentavalent antimony salts observing healing with a progressive and gradual resolution of the lesions and emphasizing the importance of early diagnosis, supervi-sed treatment, and monitoring to prevent complications.

Diagnosis, Treatment and Clinical Features of Cutaneous Leishmaniasis in Saudi Arabia

Cutaneous leishmaniasis (CL) has been one of the most common parasitic diseases in Saudi Arabia. This study exhibits the clinical features, diagnosis, cytokine profile and treatment of CL patients in Al-Taif province. Ninety CL suspects at a tertiary care general hospital were enrolled in one-year study. Patients were interviewed, clinically-examined, and subjected to laboratory tests: skin scraping smear microscopy, OligoC-TesT commercial PCR (Coris BioConcept) and kinetoplast DNA (kDNA) PCR for Leishmania diagnosis. Interferon-gamma (RayBio; Human IFN-γ) and nitric oxide (NO) levels in patients' sera were evaluated before treatment with sodium stibogluconate (pentostam) with 20-day intramuscular drug regimen. Positive rates of microscopy, commercial PCR and kDNA PCR were 74.4%, 95.5% and 100%, respectively. Patients came to hospital mostly in winter (45.0%). CL was frequently exhibited in Saudi patients (78.8%), male gender (70.7%), age < 20 years (50.0%), rural-dwellers (75.5%) and patients with travel history (86.6%). Lesion was mostly single ulcer (93.3%), occurred in the face (67.7%). Upon pentostam treatment, 85.1% of ulcers showed rapid healing signs. Levels of IFN-γ and NO were significantly higher in the healing than the non-healing cases (P < 0.001). The kDNA PCR proved more sensitive than microscopy and OligoC-TesT commercial PCR. Our results open perspectives for IFN-γ use as a biomarker predicting treatment response.

Evaluation of the Interventional Approaches in the Management of Cutaneous Leishmaniasis in Jazan: An Observational Study

BACKGROUND: Cutaneous leishmaniasis is a tropical infection of public health importance. Numerous treatment approaches are in practice with variable degree of success however its management has no universal consensus or practice guidelines to follow. OBJECTIVE: Analyze the management of cutaneous leishmaniasis retrospectively at a central hospital of Jazan Province, Kingdom of Saudi Arabia to identify the current treatment pattern and compare the outcomes. METHODS: This cross-sectional study was conducted based on the hospital records of patients who attended the dermatology clinic for cutaneous leishmaniasis during the year 2012 to 2015. RESULTS: Forty three patients were included in the study. There was a male preponderance (65.1%) among the patients and 60.5% of them were of pediatric age group. Monotherapy was the initial choice for 58.1% of the patients. Intralesional sodium stibogluconate (SS-IL) was the most preferred treatment for initial therapy, as monotherapy and as part of combination therapy. A complete response was achieved in 22 patients (51.2%) with initial therapy. Among the different treatment groups, SS-IL+itraconazole showed significantly higher complete response rate compared to other treatments offered as initial therapy (p<0.01). Initial SS-IL monotherapy provided complete response in 41.2% patients receiving it, while itraconazole monotherapy provided complete response in 75% and 90.9% of the patients receiving initial itraconazole+SS-IL combination therapy with achieved complete response. CONCLUSION: The findings and observations suggest that initial combination therapy with SS-IL+itraconazole significantly improved the complete response rates and thus reduced the need for additional or prolonged therapies.

Imported cutaneous leishmaniasis caused by Leishmania major in a Chinese laborer who worked in Saudi Arabia

Abstract: We report an imported case of cutaneous leishmaniasis in a 37-year-old man from Saudi Arabia caused by Leishmania major. He presented with non-healing nodulo-ulcerative lesions with a "volcanic crater" on the lower limbs. It was clearly cutaneous leishmaniasis - a rare disease in China - as reflected by the patient's clinical history, the lesions' morphology, histopathological examination, culture and PCR analysis of the lesions. The patient was completely cured after two cycles of sodium stibogluconate treatment. This case report demonstrates that dermatologists should be aware of sporadic cutaneous leishmaniasis cases in non-endemic areas.

Antimonial drugs entrapped into phosphatidylserine liposomes: physicochemical evaluation and antileishmanial activity

Abstract: INTRODUCTION: Leishmaniasis is a disease caused by the protozoan Leishmania that resides mainly in mononuclear phagocytic system tissues. Pentavalent antimonials are the main treatment option, although these drugs have toxic side effects and high resistance rates. A potentially alternative and more effective therapeutic strategy is to use liposomes as carriers of the antileishmanial agents. The aims of this study were to develop antimonial drugs entrapped into phosphatidylserine liposomes and to analyze their biological and physicochemical characteristics. METHODS: Liposomes containing meglumine antimoniate (MA) or pentavalent antimony salt (Sb) were obtained through filter extrusion (FEL) and characterized by transmission electron microscopy. Promastigotes of Leishmania infantum were incubated with the drugs and the viability was determined with a tetrazolium dye (MTT assay). The effects of these drugs against intracellular amastigotes were also evaluated by optical microscopy, and mammalian cytotoxicity was determined by an MTT assay. RESULTS: Liposomes had an average diameter of 162nm. MA-FEL showed inhibitory activity against intracellular L. infantum amastigotes, with a 50% inhibitory concentration (IC50) of 0.9μg/mL, whereas that of MA was 60μg/mL. Sb-FEL showed an IC50 value of 0.2μg/mL, whereas that of free Sb was 9μg/mL. MA-FEL and Sb-FEL had strong in vitro activity that was 63-fold and 39-fold more effective than their respective free drugs. MA-FEL tested at a ten-times higher concentration than Sb-FEL did not show cytotoxicity to mammalian cells, resulting in a higher selectivity index. CONCLUSIONS: Antimonial drug-containing liposomes are more effective against Leishmania-infected macrophages than the non-liposomal drugs.

Leishmaniasis mucocutánea en un paciente con infección por VIH: Case report / Mucocutaneous leishmaniasis in a HIV infected patient

Introduction: Leishmaniasis is an endemic Andean vector-borne- tropical disease in Peru, whose mucocutaneous clinical presentation is rare. Leishmaniasis can occur in co-infections with HTLV-1 virus and HIV. We describe a case of L. mucocutaneous in a patient infected with HIV, with a history of cutaneous leishmaniasis with inadequate treatment 20 years ago. He was treated with stibogluconate with adequate response to treatment and regression of lesion after 4 weeks. Mucocutaneous leishmaniasis and HIV coinfection is rare and its clinical presentation may be atypically. It is important to consider it in patients coming from endemic areas and with a history of a previous cutaneous clinical presentation.

La leishmaniasis es una enfermedad metaxénica andino-tropical, considerada endémica en Perú. Su forma mucocutánea es poco frecuente. Puede presentarse en coinfección con los virus HTLV-1 y VIH. Se describe un caso de leishmaniasis mucocutánea en un paciente infectado con VIH, con antecedente de leishmaniasis cutánea con tratamiento incompleto 20 años atrás. Es tratado con estibogluconato sódico por 30 días, con adecuada respuesta y regresión de la lesión a las cuatro semanas. La coinfección de leishmaniasis mucocutánea y VIH no es frecuente. Las manifestaciones de leishmaniasis pueden no presentarse de forma típica en pacientes con VIH. Se debe considerar la procedencia de la zona endémica y/o el antecedente de haber presentado la forma cutánea previamente.

Falla terapéutica y hepatotoxicidad de los esquemas de tratamiento endovenoso e intramuscular con estibogluconato de sodio en pacientes con leishmaniasis cutánea / Therapeutic failure and hepatotoxicity with schemes intravenous and intramuscular sodium stibogluconate treatment in patients with cutaneous leishmaniasis

OBJETIVO. Describir la falla terapéutica y hepatotoxicidad de los esquemas de tratamiento endovenoso e intramuscular con estibogluconato de sodio en pacientes con leishmaniasis cutánea. MATERIAL y MÉTODOS. Estudio de cohorte única retrospectivo. Los pacientes fueron tratados con estibogluconato de sodio con el esquema endovenoso continuo por 20 días en una sola dosis, los que presentaron falla terapéutica recibieron un segundo curso de estibogluconato de sodio con el esquema intramuscular dosis dividido en series de la días de tratamiento con intervalos de 7 días de descanso por 3 series. Se revisó las historias clínicas y se evaluó en ambos grupos la falla terapéutica y hepatotoxicidad. RESULTADOS. Cumplieron los criterios de inclusión/exclusión 64 pacientes, todos varones. Leishmania braziliensis fue la especie de leishmania infectante en 96,4 % de casos. La cura fue de 48,4 % en el esquema endovenoso, L. braziliensis fue la única especie identificada en los pacientes con falla terapéutica. La hepatotoxicidad fue de 28,1 % en el esquema endovenoso y 6,3 % en el esquema intramuscular. El grupo de pacientes que falló con el esquema endovenoso y repitió el tratamiento pero con el esquema intramuscular (32 pacientes) tuvo un porcentaje de cura de 100 %; solo 2 pacientes (6,3 %) que recibieron el esquema intramuscular desarrollaron hepatotoxicidad durante el tratamiento. CONCLUSIONES. Existe una alta frecuencia de falla terapéutica y hepatotoxicidad en pacientes con Leishmaniasis cutánea tratados con estibogluconato de sodio con el uso del esquema endovenoso. Los pacientes tratados con el esquema intramuscular no presentan falla terapéutica y tienen una baja frecuencia de hepatotoxicidad.

OBJECTIVE. Describe the therapeutic failure and hepatotoxicity schemes intravenous and intramuscular sodium stibogluconate treatment in patients with cutaneous leishmaniasis (CL). MATERIAL AND METHODS. Retrospective single cohort study. Patients were treated with sodium stibogluconate with continuous intravenous scheme for 20 days in a single dose; those with therapeutic failure received a second course of sodium stibogluconate with intramuscular scheme doses divided into sets of 10 days of treatment with intervals 7 days off per 3 series. The medical records were reviewed and evaluated in both groups treatment failure and hepatotoxicity. RESULTS. They met the inclusion/exclusion of 64 patients, all males. The specie of leishmania was present in 96,4 % of cases was the Leishmania braziliensis. Curing was 48,4 % for the intravenous scheme, L. braziliensis was the only species identified in patients with therapeutic failure. Hepatotoxicity was 28,1% in the scheme intravenous and intramuscular 6,3 % in the scheme. The group of patients who failed with the scheme and repeated intravenous treatment but with the intramuscular scheme (32 patients) had a cure rate of 100 %; only 2 patients (6,3 %) who received intramuscular scheme developed hepatotoxicity during treatment. CONCLUSIONS. There is a high rate of treatment failure and hepatotoxicity in patients treated with CL with sodium stibogluconate intravenous use scheme. Patients treated with intramuscular scheme have no therapeutic failure and have a low frequency of hepatotoxicity.

New World Cutaneous Leishmaniasis Treated with Intralesional Injection of Pentavalent Antimony

Cutaneous leishmaniasis is a skin infection caused by the Leishmania species, an intracellular protozoan parasite that is transmitted by various species of female sandflies. According to the geographic distribution and vectors, leishmaniasis is classified as Old World or New World cutaneous leishmaniasis. In Korea, 24 cases of Old World cutaneous leishmaniasis have been reported, but New World cutaneous leishmaniasis has not been reported as yet. A 37-year-old man presented with a 3-month history of a painful and erythematous nodule with two satellite papules on the left postauricular area and a papule on the left arm after traveling to the Amazon region in Brazil. After we performed skin biopsies of the lesions, diagnosis of cutaneous leishmaniasis was made by the histopathological findings. After intralesional injection of sodium stibogluconate (Pentostam(R), GlaxoSmithKline) twice a week for 4 weeks, the lesions improved with scarring. Herein, we discuss this case of New World cutaneous leishmaniasis that was successfully treated with intralesional injection of sodium stibogluconate (Pentostam(R)) in Korea.

New World Cutaneous Leishmaniasis Treated with Intralesional Injection of Pentavalent Antimony

Cutaneous leishmaniasis is a skin infection caused by the Leishmania species, an intracellular protozoan parasite that is transmitted by various species of female sandflies. According to the geographic distribution and vectors, leishmaniasis is classified as Old World or New World cutaneous leishmaniasis. In Korea, 24 cases of Old World cutaneous leishmaniasis have been reported, but New World cutaneous leishmaniasis has not been reported as yet. A 37-year-old man presented with a 3-month history of a painful and erythematous nodule with two satellite papules on the left postauricular area and a papule on the left arm after traveling to the Amazon region in Brazil. After we performed skin biopsies of the lesions, diagnosis of cutaneous leishmaniasis was made by the histopathological findings. After intralesional injection of sodium stibogluconate (Pentostam(R), GlaxoSmithKline) twice a week for 4 weeks, the lesions improved with scarring. Herein, we discuss this case of New World cutaneous leishmaniasis that was successfully treated with intralesional injection of sodium stibogluconate (Pentostam(R)) in Korea.

Leishmaniasis: current status of available drugs and new potential drug targets

The control of Leishmania infection relies primarily on chemotherapy till date. Resistance to pentavalent antimonials, which have been the recommended drugs to treat cutaneous and visceral leishmaniasis, is now widespread in Indian subcontinents. New drug formulations like amphotericin B, its lipid formulations, and miltefosine have shown great efficacy to treat leishmaniasis but their high cost and therapeutic complications limit their usefulness. In addition, irregular and inappropriate uses of these second line drugs in endemic regions like state of Bihar, India threaten resistance development in the parasite. In context to the limited drug options and unavailability of either preventive or prophylactic candidates, there is a pressing need to develop true antileishmanial drugs to reduce the disease burden of this debilitating endemic disease. Notwithstanding significant progress of leishmanial research during last few decades, identification and characterization of novel drugs and drug targets are far from satisfactory. This review will initially describe current drug regimens and later will provide an overview on few important biochemical and enzymatic machineries that could be utilized as putative drug targets for generation of true antileishmanial drugs.

Cardiotoxicidad por antimoniales / Antimonials cardiotoxicity

Las políticas de vigilancia epidemiológica en Colombia han hecho énfasis en el diagnóstico y el tratamiento oportuno de la leishmaniasis en cualquiera de sus formas (visceral, cutánea o mucocutánea), sin embargo, no existe control sobre las reacciones adversas que pueden presentar los pacientes medicados con los antimoniales pentavalentes, fármacos usados en el país para tratar esta enfermedad tropical. A pesar de ser medicamentos empleados durante décadas, sus mecanismos de acción no están del todo establecidos y en parte tampoco sus reacciones adversas, sin embargo, es de suma importancia prevenirlas y saber como actuar en caso de presentarse. El caso reportado muestra como reacción adversa cardiotoxicidad secundaria a tratamiento con estibogluconato de sodio en una paciente con diagnóstico de leishmaniasis cutánea, asociado a hipokalemia; en una cuidadosa comparación con casos reportados y estudios epidemiológicos se puede establecer una asociación de antimoniales y síndrome de QT largo como primer paso de la cascada letal de cardiotoxicidad.

Surveillance policies in Colombia have emphasized diagnosis and timely treatment of leishmaniasis in any of its forms (visceral, cutaneous or mucocutaneous), however there is no control on adverse reactions that may occur in patients taking pentavalent antimonials, drugs used in the country to try this tropical disease. Despite being drugs used for decades, their action mechanisms are not fully established and neither their adverse reactions, all the same, it is extremely important to prevent them and know what to do if it presents. The reported case shows as adverse reaction, secondary cardiotoxicity to sodium stibogluconate treatment in a patient with diagnosis of cutaneous leishmaniasis associated with hypokalemia, in close comparison with case reports and epidemiological studies it can be set an association of antimony and long QT syndrome as the first step of the cascade lethal cardiotoxicity.

Complejo Leishmania braziliensis: descripción de un caso pediátrico y revisión de la literatura / Leishmania braziliensis complex: description of a pediatric case and review of the literature

La leishmaniasis es una enfermedad infecciosa, no contagiosa, de evolución crónica, causada por un protozoario del género Leishmania y transmitida al hombre a través de la picadura del flebótomo hembra infectado, vector de la enfermedad. Presentamos el caso de un lactante menor con leishmaniasis cutánea localizada, que tuvo buena respuesta al tratamiento con antimoniato de N-metilglucamina.

Leishmaniasis is a chronic, infectious but not contagious disease caused by a protozoan of the genus Leishmania that is transmitted to humans through the bite of infected female sand fly, which is the vector of the disease. We present the case of an infant with localized cutaneous leishmaniasis who had a good response to the treatment with N-methylglucamine antimoniate.

Monoclonal gammopathy associated with visceral leishmaniasis

Monoclonal gammopathy can accompany diverse conditions and is usually benign. It should be distinguished from monoclonal gammopathy of undetermined significance (MGUS) which can rarely turn malignant. Visceral leishmaniasis has only rarely been associated with monoclonal gammopathy. We describe the case of a 55-year-old male who had monoclonal gammopathy associated with visceral leishmanisais, which reversed with stibogluconate therapy.

A Case of Post Kala-Azar Dermal Leishmaniasis in India

Post kala-azar dermal leishmaniasis (PKDL) is a rare disease. This is a solitary case report from Orissa, India. We describe a case of PKDL in a 55-year-old male who presented with multiple nodular lesions over face, trunk, and extremities. The patient had been to an endemic area of kala-azar and had a previous history of leishmaniasis. Fine needle aspiration cytology samples from skin nodules revealed Leishmania amastigotes.

Emerging cutaneous leishmaniasis in Sirte-Libya: epidemiology, recognition and management

The present work aimed to determine the risk factors, lesion pattern and effective therapy of emerging ZCL in Sirte-Libya. The study was carried out on 163 patients referred to health centers of Al-Gadaheya and Al-Hisha villages in the years 2006 and 2007. Methods consisted of a predesigned questionnaire [personal and demographic data], clinical examination of lesions, and parasitological examination by slit smear, treatment and follow up. Results showed an annual incidence of 0.95%, with onset peak during autumn months. Important local risk factors included: increased occupational exposure of farmers and construction worker to infection from fat sand rat burrows, facilitated by lack of prevention knowledge and prophylactic measures; close association of bad-ventilated animal shelters to houses, and increased soil moisture by warm spring ponds. The majority of lesions were multiple [73%] located on legs, arms, and face 66.8%, 52.1% and 41.1%. Most lesions were active 1-2 month duration and 1-3 cm size, ulcerative type [77.3%], and papulo-nodular [21.5%]. Giemsa slit smear proved quite reliable for active lesions, confirmed 79.5% of lesions. The majority of lesions [60.1%] were treated by intra-lesional Pen-tostam. Systemic route was restricted to facial, over-joint, multiple or large lesions producing good response in 31.9%. Cryotherapy and oral Fluconazole gave satisfactory response in 5.5% and 2.5% of cases

Acute erythroid toxicity in visceral leishmaniasis: a rare complication of antimonial therapy.

The spectrum of side-effects of sodium stibogluconate is well described, however, little is known regarding the acute erythroid toxicity caused by this drug. We hereby present a case with this unusual complication of antimonial therapy. A 6-year-old male with leishmaniasis was started on parenteral sodium stibogluconate. During the course of treatment, his hemoglobin (Hb) dropped from 7.2 g/dl to 3.5 g/dl. Bone-marrow aspirate showed karyorrhexis in many erythroid precursors with several Leishmania donovanii bodies. Sodium stibogluconate was stopped and amphotericin-B was started. Four days after the cessation of the antimonials, the patient's Hb improved to 5 gm/dl with a corrected reticulocyte count of 10% indicating bone-marrow erythroid regeneration. The exact mechanism of this acute erythroid toxicity of sodium stibogluconate remains unexplored.

Comparison of treatment regimens of kala-azar based on culture & sensitivity of amastigotes to sodium antimony gluconate.

BACKGROUND & OBJECTIVE: Present treatment strategies for kala-azar (visceral leishmaniasis, VL) include use of first line drug sodium antimony gluconate (SAG) to all patients but a large number of patients do not get relief with this drug. If a patient does not respond to a full course of SAG, a second or third line drug is given. We undertook this study to test whether an improved outcome can be achieved by employing a strategy of treatment based on culture and sensitivity of amastigotes to SAG compared with conventional empirical treatment. METHODS: In a double-blind, randomized, controlled trial done in Balaji Utthan Sansthan, Patna, of the 181 patients screened,140 were finally randomly allocated to two groups A and B; group A patients were treated with SAG if their amastigotes were sensitive to SAG, and all patients in group B were treated with SAG to start with. Primary outcome measured was as no relapse within 6 months of follow up after cure and other outcomes measured were period of stay of patients in hospital, expenditure involved in the treatment, and infectivity periods of two groups, two-third of treatment period and whole of untreated period were taken as infectivity period. SAG was used at a dosage of 20 mg/kg given deep intramuscular injections in buttock for 28 days, amphotericin B (AMB) given at a dose of 1 mg/kg body wt daily for 20 days as a slow intravenous infusion in 5 per cent dextrose. RESULTS: Of the 70 patients in group A, 29 patients whose amastigotes were sensitive to SAG were treated with SAG, 2 patients were withdrawn due to drug toxicity; and 2 relapsed within 6 months of follow up and ultimate cure occurred in 25 (86.2%) patients only. Of the 70 patients in group B treated with SAG, 5 (7.1%) patients withdrew due to drug toxicity, 35 patients (50%) did not respond to treatment, 5 (7.1%) relapsed during 6 months of follow up and thus only 25 patients (35.7%) were ultimately cured. The difference between the two groups was significant (P<0.001). No patient died during treatment due to any toxicity because of early withdrawal of patients from treatment apprehending toxicity. Patients whose amastigotes were resistant to SAG, withdrawn from the study due to SAG toxicity, relapsed after cure with SAG, and who did not respond to SAG in both the groups were treated with AMB and all were cured. Groups B and A patients spent 3065 and 2340 days respectively in hospital, group B 1.3 times more than group A. The likely period of spread of parasites in society was 1965 days in group B and 1644 days in group A, group B 1.4 times more than group A. The total expenditure on treatment in groups B and A was dollars 65,575 and dollars 50,590 respectively; group B patient had to spend 1.3 times more than group A. INTERPRETATION & CONCLUSION: A new strategy for treatment of kala-azar based on culture and sensitivity of amastigotes improved the cure rate, saved expenditure on the patient's treatment, patients had to stay for shorter periods in hospital and reduced the chance of spread of SAG resistant disease in society. Till the government opts for better drugs, the treatment based on culture and sensitivity of the parasites to SAG may be a better method.