Amphotericin B Treatment in Visceral Leishmaniasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Brief Summary

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This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

Detailed Description

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This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

Conditions

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Visceral Leishmaniasis

Keywords

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visceral leishmaniasis amphotericin B Kala-azar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Amphotericin B deoxycholate given as daily administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Parasitologically proved kala-azar

Exclusion Criteria

* HIV positive serology

Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Shyam Sundar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine

Locations

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Kala-azar Medical Research Center

Muzaffarpur, Bihar, India

Site Status

Countries

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India

References

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Sundar S, Chakravarty J, Rai VK, Agrawal N, Singh SP, Chauhan V, Murray HW. Amphotericin B treatment for Indian visceral leishmaniasis: response to 15 daily versus alternate-day infusions. Clin Infect Dis. 2007 Sep 1;45(5):556-61. doi: 10.1086/520665. Epub 2007 Jul 23.

Reference Type DERIVED

PMID: 17682988 (View on PubMed)

Other Identifiers

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SS01MZP03

Identifier Type: -

Identifier Source: org_study_id