Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol

June 1, 2010 updated by: Combined Military Hospital, Pakistan

Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate 20 Mg/Kg/Day Versus Meglumine Antimoniate 10 Mg/Kg/Day And Tablet Allopurinol 20 Mg/Kg/Day

Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. For the last 60 years antimony compounds are considered the treatment of choice. Though their use is expensive, cumbersome, has many adverse effects and not effective in all patients, the search for a better alternative is still going on. Low dose antimony compounds in combination with several agents have shown promise of reducing adverse effects of antimony compounds without compromising efficacy. Allopurinol is one such agent which though promising lacks randomized, controlled trials to prove efficacy. The main objective of this study is to evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium stibogluconate in terms of efficacy and adverse effects.

Methods and design: A multi-center randomized, controlled trial including 620 patients from endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study. After evaluating the inclusion/exclusion criteria patients will be randomized to receive either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During treatment patients will be admitted to hospital and monitored daily for the presence of adverse effects. Follow up period will last six months during which patients will visits the research centers for assessment of healing process at monthly intervals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Kharian Cantonment, Punjab, Pakistan, 74400
        • Combined Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women between 18 and 50 years old.
  • Cutaneous ulcers, nodules, plaques, of more than two weeks of evolution requiring systemic therapy.
  • Positive parasitological diagnosis for cutaneous leishmaniasis.
  • Patients that voluntarily accept to participate in the study and sign the informed consent.
  • Disposition to be admitted to hospital, if necessary, and to attend all the visits punctually (initial, treatment and follow up).
  • Acceptation of not using any other treatment for cutaneous leishmaniasis while in the study.

Exclusion Criteria:

  • Pregnant women.
  • Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of cutaneous leishmaniasis.
  • Diffuse cutaneous leishmaniasis.
  • Visceral leishmaniasis.
  • Complete or incomplete treatment with antimony compounds in the last three months.
  • Patients with history of hepatic, renal, or cardiovascular disease.
  • Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
injection meglumine antimoniate 20 mg/kg/day/intramuscular for 21 days.
Drug: meglumine antimoniate
injectable 20 mg/kg/day/intramuscular for 21 days.
Experimental: 2
injection meglumine antimoniate 10 mg/kg/day/intramuscular plus tablet allopurinol 1200 mg/day/6hourly divided doses.
Drug: meglumine antimoniate, allopurinol
first drug in injectable, second is in tablet form.
Drug: meglumine antimoniate, allopurinol
injectable meglumine antimoniate 10 mg/kg/day/intramuscular for 21 days plus tablet allopurinol 300mg/4times a day for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical healing of lesions.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement of more than 50% in lesion size
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital, Pakistan

Investigators

  • Principal Investigator: AMER EJAZ, FCPS, Combined Military Hospital, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 29, 2007

First Submitted That Met QC Criteria

May 30, 2007

First Posted (Estimate)

May 31, 2007

Study Record Updates

Last Update Posted (Estimate)

June 2, 2010

Last Update Submitted That Met QC Criteria

June 1, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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