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

This study has been completed.
Sponsor:
Information provided by:
Combined Military Hospital, Pakistan
ClinicalTrials.gov Identifier:
NCT00480883
First received: May 29, 2007
Last updated: June 1, 2010
Last verified: May 2008
  Purpose

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.


Condition Intervention
Leishmaniasis, Cutaneous
Drug: meglumine antimoniate, allopurinol
Drug: meglumine antimoniate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Combined Military Hospital, Pakistan:

Primary Outcome Measures:
  • clinical healing of lesions. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • improvement of more than 50% in lesion size [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480883

Locations
Pakistan
Combined Military Hospital
Kharian Cantonment, Punjab, Pakistan, 74400
Sponsors and Collaborators
Combined Military Hospital, Pakistan
Investigators
Principal Investigator: AMER EJAZ, FCPS Combined Military Hospital, Pakistan
  More Information

Publications:
Responsible Party: DR AMER EJAZ, COMBINED MILITARY HOSPITAL, KHARIAN, PAKISTAN
ClinicalTrials.gov Identifier: NCT00480883     History of Changes
Other Study ID Numbers: 001
Study First Received: May 29, 2007
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Combined Military Hospital, Pakistan:
cutaneous leishmaniasis of the old world

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Meglumine
Allopurinol
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014