Status:
COMPLETED
To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
Lead Sponsor:
Bharat Serums and Vaccines Limited
Collaborating Sponsors:
Ministry of Science and Technology
Conditions:
Leishmaniasis, Visceral
Eligibility:
All Genders
5-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in trea...
Detailed Description
Visceral Leishmaniasis, which is progressive and fatal if not treated, is an insidious, chronic disease that is characterized by irregular fever, anorexia, weight loss, cough, gross enlargement of the...
Eligibility Criteria
Inclusion
- Male or female patients aged between 5 to 65 years (both inclusive).
- Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration and splenomegaly)
- Presence of amastigotes (Leishmania-Donovani bodies) at prescreening detected by rK39 dipstick test with confirmation by splenic or bone marrow aspirate smear examination.
- Non-pregnant, non-lactating females of age ≥5 years, and woman of childbearing potential who are willing to use acceptable methods of contraception
- Negative Urine pregnancy test (UPT) in all women
Exclusion
- Patients with past history of treatment with Amphotericin B or any other drug for Visceral Leishmaniasis within 30 days prior to screening.
- Patients positive for HIV, HCV and HBsAg infection, immunocompromised patients (through history).
- Concurrent diabetes, tuberculosis or bacterial pneumonia or any other infectious or major psychiatric disease.
- Pregnant or nursing women
- Patients receiving any of the medications prohibited by the study protocol.
- Simultaneous participation in another trial or received any IP \<30 days prior to enrolment.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00876824
Start Date
July 1 2009
End Date
January 1 2011
Last Update
June 2 2011
Active Locations (4)
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1
Muzaffarpur, Bihar, India, 842001
2
Muzaffarpur, Bihar, India, 842003
3
Patna, Bihar, India, 800001
4
Patna, Bihar, India, 800007