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

NCT ID: NCT00480883

Last Updated: 2010-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-12-31

Brief Summary

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.

Conditions

Leishmaniasis, Cutaneous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

injection meglumine antimoniate 20 mg/kg/day/intramuscular for 21 days.

Group Type: ACTIVE_COMPARATOR

meglumine antimoniate

Intervention Type: DRUG

injectable 20 mg/kg/day/intramuscular for 21 days.

2

injection meglumine antimoniate 10 mg/kg/day/intramuscular plus tablet allopurinol 1200 mg/day/6hourly divided doses.

Group Type: EXPERIMENTAL

meglumine antimoniate, allopurinol

Intervention Type: DRUG

first drug in injectable, second is in tablet form.

meglumine antimoniate, allopurinol

Intervention Type: DRUG

injectable meglumine antimoniate 10 mg/kg/day/intramuscular for 21 days plus tablet allopurinol 300mg/4times a day for 21 days.

Interventions

meglumine antimoniate, allopurinol

first drug in injectable, second is in tablet form.

Intervention Type: DRUG

meglumine antimoniate

injectable 20 mg/kg/day/intramuscular for 21 days.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Combined Military Hospital, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

COMBINED MILITARY HOSPITAL, KHARIAN, PAKISTAN

Principal Investigators

AMER EJAZ, FCPS

Role: PRINCIPAL_INVESTIGATOR

Combined Military Hospital, Pakistan

Locations

Combined Military Hospital

Kharian Cantonment, Punjab Province, Pakistan

Countries

Pakistan

References

Momeni AZ, Reiszadae MR, Aminjavaheri M. Treatment of cutaneous leishmaniasis with a combination of allopurinol and low-dose meglumine antimoniate. Int J Dermatol. 2002 Jul;41(7):441-3. doi: 10.1046/j.1365-4362.2002.01527.x.

Reference Type: BACKGROUND

PMID: 12121563 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id