Clinical trial NCT00876824: To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
Official title: A Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul® (Amphotericin B Emulsion) As Compared To Liposomal Amphotericin In Patients Of Visceral Leishmaniasis (Kala Azar)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leishmaniasis, Visceral
Keywords: Black Fever
Kala-Azar
Amphotericin B lipid emulsion
Liposomal Amphotericin B
Lead sponsor: Bharat Serums and Vaccines Limited
Sponsor class: INDUSTRY
Collaborators: name: Ministry of Science and Technology
First posted: 2009-04-07
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treating patients with Indian Visceral Leishmaniasis (Kala Azar).

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 spleen and liver, mild anemia and emaciation. This may be preceded by rigors and vomiting. If untreated, Kala-azar, which is the most severe form of Leishmaniasis, has a mortality rate of nearly 100%.

The goal of the project is to establish that a single dose of AMPHOMUL® can be used to achieve a Definitive cure for Visceral Leishmaniasis leading to a short course therapy. The project will also seek to establish that AMPHOMUL ® is safe, at least as effective and more affordable than current treatment, and is without the risk of drug resistance.

The trial is a Prospective, Multicentric, Randomized, Two Arm, Open label Phase III study to Assess Efficacy and Safety of Infusion of Amphomul® (Amphotericin B Emulsion) as Compared to Liposomal Amphotericin B in Patients of Visceral Leishmaniasis (Kala azar)who are either treatment naive or treatment resistant to other antileishmanial drugs.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months
timeFrame: Six months after dose administration
Secondary outcomes:
measure: To assess the Number of AEs, SAEs, Incidence of IRTs, with no Incidence of nephrotoxicity and hepatotoxicity and no change in the Laboratory values for different parameters
timeFrame: within 30 to 45 days from drug administration and continue throughout duration of study
Other outcomes:
Locations:
city: Muzaffarpur
country: India
state: Bihar
city: Muzaffarpur
country: India
state: Bihar
city: Patna
country: India
state: Bihar
city: Patna
country: India
state: Bihar
Study officials:
affiliation: Bharat Serums and Vaccines Ltd
name: Dr. Gautam Daftary, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundar S, Pandey K, Thakur CP, Jha TK, Das VN, Verma N, Lal CS, Verma D, Alam S, Das P. Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, open-label study. PLoS Negl Trop Dis. 2014 Sep 18;8(9):e3169. doi: 10.1371/journal.pntd.0003169. eCollection 2014 Sep.