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To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar

Primary Purpose

Leishmaniasis, Visceral

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Amphotericin B Lipid emulsion

Liposomal Amphotericin B

About this trial

This is an interventional treatment trial for Leishmaniasis, Visceral focused on measuring Black Fever, Kala-Azar, Amphotericin B lipid emulsion, Liposomal Amphotericin B

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amphotericin B lipid emulsion

Liposomal Amphotericin B

Arm Description

Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A Drug: Amphotericin B lipid emulsion

Liposomal Amphotericin B in visceral leishmaniasis - 15mg/kg on day 1 in Group B

Outcomes

Primary Outcome Measures

Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00876824

First Posted

April 6, 2009

Last Updated

June 1, 2011

Sponsor

Bharat Serums and Vaccines Limited

Collaborators

Ministry of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT00876824

Brief Title

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

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bharat Serums and Vaccines Limited

Collaborators

Ministry of Science and Technology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leishmaniasis, Visceral

Keywords

Black Fever, Kala-Azar, Amphotericin B lipid emulsion, Liposomal Amphotericin B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amphotericin B lipid emulsion

Arm Type

Experimental

Arm Description

Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A Drug: Amphotericin B lipid emulsion

Arm Title

Liposomal Amphotericin B

Arm Type

Active Comparator

Arm Description

Liposomal Amphotericin B in visceral leishmaniasis - 15mg/kg on day 1 in Group B

Intervention Type

Drug

Intervention Name(s)

Amphotericin B Lipid emulsion

Other Intervention Name(s)

Amphomul

Intervention Description

Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis

Intervention Type

Drug

Intervention Name(s)

Liposomal Amphotericin B

Other Intervention Name(s)

AmBisome

Intervention Description

Liposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B

Primary Outcome Measure Information:

Title

Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months

Time Frame

Six months after dose administration

Secondary Outcome Measure Information:

Title

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

Time Frame

within 30 to 45 days from drug administration and continue throughout duration of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Gautam Daftary, MBBS

Organizational Affiliation

Bharat Serums and Vaccines Ltd

Official's Role

Principal Investigator

Facility Information:

City

Muzaffarpur

State/Province

Bihar

ZIP/Postal Code

842001

Country

India

City

Muzaffarpur

State/Province

Bihar

ZIP/Postal Code

842003

Country

India

City

Patna

State/Province

Bihar

ZIP/Postal Code

800001

Country

India

City

Patna

State/Province

Bihar

ZIP/Postal Code

800007

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

25233346

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.

Results Reference

derived

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To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar

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