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

NCT00480883 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

cutaneous leishmaniasis of the old world

Outcome Measures

Primary Outcomes (1)

• clinical healing of lesions.

  3 months

Secondary Outcomes (1)

• improvement of more than 50% in lesion size

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: meglumine antimoniate

2

EXPERIMENTAL

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

Drug: meglumine antimoniate, allopurinol

Interventions

meglumine antimoniate, allopurinol DRUG

first drug in injectable, second is in tablet form.

2

meglumine antimoniate DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Combined Military Hospital, Pakistan: lead

Study Sites (1)

Combined Military Hospital

Kharian Cantonment, Punjab Province, 74400, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 12121563 BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Meglumine Antimoniate; Allopurinol

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• AMER EJAZ, FCPS

  Combined Military Hospital, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2007
• First Posted: May 31, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 2, 2010

Record last verified: 2008-05

Locations

PA (1)