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

This study has been completed.
Sponsor:
Information provided by:
University of Brasilia
ClinicalTrials.gov Identifier:
NCT00818818
First received: January 6, 2009
Last updated: October 7, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Localized Cutaneous Leishmaniasis
Drug: Meglumine antimoniate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial.

Resource links provided by NLM:


Further study details as provided by University of Brasilia:

Primary Outcome Measures:
  • Clinical cure [ Time Frame: Three months after treatment ] [ Designated as safety issue: No ]
    Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)


Secondary Outcome Measures:
  • Adverse events rate - day 7 [ Time Frame: 7th day ] [ Designated as safety issue: Yes ]
    Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the first week of treatment

  • Adverse events rate - day 14 [ Time Frame: 14th day ] [ Designated as safety issue: Yes ]
    Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the second week of treatment

  • Total Adverse events rate [ Time Frame: 20th day ] [ Designated as safety issue: Yes ]
    Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the whole treatment


Enrollment: 13
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meglumine antimoniate
Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days.
Drug: Meglumine antimoniate
5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days
Other Name: Glucantime

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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: NCT00818818

Locations
Brazil
Health Center Unit of Corte de Pedra
Corte de Pedra, Presidente Tancredo Neves, Bahia State, Brazil, 45416 - 000
Sponsors and Collaborators
University of Brasilia
Investigators
Principal Investigator: Julia S Ampuero-Vela, MD, MSc Faculty of Medicine, University of Brasilia
Study Chair: Gustavo Adolfo S Romero, MD, PhD Faculty of Medicine, University of Brasilia
  More Information

No publications provided

Responsible Party: Gustavo Adolfo Sierra Romero, Faculty of Medicine, University of Brasilia
ClinicalTrials.gov Identifier: NCT00818818     History of Changes
Other Study ID Numbers: lowdoseaging
Study First Received: January 6, 2009
Last Updated: October 7, 2010
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Brasilia:
Leishmaniasis
Cutaneous leishmaniasis
Leishmania braziliensis
Pentavalent antimonial
Glucantime

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Meglumine
Meglumine antimoniate
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014