Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients

NCT00818818 | Completed Phase 4

• 1 other identifier: lowdoseaging
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.

Conditions

Localized Cutaneous Leishmaniasis

Keywords

Leishmaniasis; Cutaneous leishmaniasis; Leishmania braziliensis; Pentavalent antimonial; Glucantime

Outcome Measures

Primary Outcomes (1)

• Clinical cure

  Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)

  Three months after treatment

Secondary Outcomes (3)

• Adverse events rate - day 7

  7th day

• Adverse events rate - day 14

  14th day

• Total Adverse events rate

  20th day

Study Arms (1)

Meglumine antimoniate

EXPERIMENTAL

Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days.

Drug: Meglumine antimoniate

Interventions

Meglumine antimoniate DRUG

5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days

Also known as: Glucantime

Meglumine antimoniate

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 65 years
• Permanent residence in the endemic area
• Availability of a caregiver for dependent patients

You may not qualify if:

• Mucosal disease caused by leishmaniasis
• Disseminated cutaneous disease
• Severe cardiac, renal or hepatic disorders
• Active cancer
• Active tuberculosis
• Leprosy
• HIV positive
• Total bilirubin \> 1.5mg/dL
• Urea and creatinin \> 1.5 times the upper normal level
• Alkaline phosphatase and aminotransferases \> 2.5 times the upper normal level
• Lipase and amylase \> 1.5 the upper normal level
• Hemoglobin \< 5 g/dL of

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Health Center Unit of Corte de Pedra

Corte de Pedra, Presidente Tancredo Neves, Bahia State, 45416 - 000, Brazil

Location

MeSH Terms

Conditions

Leishmaniasis; Leishmaniasis, Cutaneous

Interventions

Meglumine Antimoniate

Condition Hierarchy (Ancestors)

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

Study Officials

• Julia S Ampuero-Vela, MD, MSc

  Faculty of Medicine, University of Brasilia

  PRINCIPAL INVESTIGATOR

• Gustavo Adolfo S Romero, MD, PhD

  Faculty of Medicine, University of Brasilia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 8, 2009
• Study Start: August 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 8, 2010

Record last verified: 2010-10

Locations

BR (1)