NCT00876824

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 2, 2011

Status Verified

June 1, 2011

Enrollment Period

1.5 years

First QC Date

April 6, 2009

Last Update Submit

June 1, 2011

Conditions

Leishmaniasis, Visceral

Keywords

Black FeverKala-AzarAmphotericin B lipid emulsionLiposomal Amphotericin B

Outcome Measures

Primary Outcomes (1)

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

    Six months after dose administration

Secondary Outcomes (1)

  • 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

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

Study Arms (2)

Amphotericin B lipid emulsion

EXPERIMENTAL

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

Drug: Amphotericin B Lipid emulsion

Liposomal Amphotericin B

ACTIVE COMPARATOR

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

Drug: Liposomal Amphotericin B

Interventions

Amphotericin B Lipid emulsionDRUG

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

Also known as: Amphomul
Amphotericin B lipid emulsion
Liposomal Amphotericin BDRUG

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

Also known as: AmBisome
Liposomal Amphotericin B

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Muzaffarpur, Bihar, 842001, India

Location

Unknown Facility

Muzaffarpur, Bihar, 842003, India

Location

Unknown Facility

Patna, Bihar, 800001, India

Location

Unknown Facility

Patna, Bihar, 800007, India

Location

Related Publications (1)

  • 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.

    PMID: 25233346DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Officials

  • Dr. Gautam Daftary, MBBS

    Bharat Serums and Vaccines Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 2, 2011

Record last verified: 2011-06

Locations

IN(4)