iposomal amphotericin B for the treatment of Nepalese patients with visceral leishmaniasis.

Phase 2

Completed

• Conditions: Visceral Leishmaniasis; Infection - Other infectious diseases

• Registration Number: ACTRN12610000130066
• Lead Sponsor: The United Nations Children's Fund (UNICEF)/ The United Nations Development Programme (UNDP) /World Bank /World Health Organization (WHO) Special Programme for Research and Training in Tropical Diseases (TDR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1 Children and adults of ages between 2 and 65 years (inclusive)
2 Fever for more than two weeks
3 Splenomegaly
4 rK39 rapid test positive
5 Confirmed diagnosis of VL by visualization of parasites on splenic aspirate
6 Biochemical and haematological test values as follows
-Haemoglobin equal/greater than 6 g/dl
-White blood cell count equal/ greater than 1.0 x 109/L
-Platelets equal/greater than 50 x109/L
-Prothrombin time equal /lower than 5 sec above control
-Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) equal/lower than 3 times the upper limit of normal
-Bilirubin equal/lower than 1.5 times the upper limit of normal
-Serum creatinine level within normal limit
7 immunodeficiency virus antibody test (HIV) negative serology
8 Written informed consent from the patient/or from parent or guardian if under 18 years old

Exclusion Criteria

1. A history of intercurrent or concurrent diseases (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or Central Nervous System (CNS) disease; diabetes mellitus, other infectious diseases or major psychiatric diseases) that may introduce variables that affect the outcome of the study
2. Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up
3. A history of allergy or hypersensitivity to Amphotericin B
4. Previous treatment for VL within two months of enrolment into the study
5. Prior treatment failure with Amphotericin B
6. Post Kala-azar Dermal Leishmaniasis (PKDL)
7. Concomitant treatment with other anti-leishmanial drugs
8. Pregnant women or lactating mother

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of liposomal amphotericin B in a daily dose of 3mg/kg body weight for 5 consecutive days. Efficacy will be based on clinical response (No fever, weight gain = 0.5 kg compared with baseline, and any decrease in spleen size compared with baseline), laboratory findings (Increase of haemoglobin by 10% compared to baseline or to at least 10g/dl) and parasitological assessment (eradication of parasite at day 19 or 45 after end of treatment)[Six months after end of treatment]

Secondary Outcome Measures

Name	Time	Method
To assess the safety of liposomal amphotericin B when administered in the proposed dosage regimen. Safety will be assess by recording and calculation of overall incidence of all adverse events which is defined as any unfavorable and unintended sign including an abnormal laboratory (or vital, etc.) finding, symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.[During treatment, at end of treatment and at six months after end of treatment]