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

Phase 2

Active, not recruiting

• Conditions: Visceral leishmaniasis (VL); Infection - Other infectious diseases

• Registration Number: ACTRN12609001029280
• 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: 2009-11-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• 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