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NCT Number: NCT00818818

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Health Center Unit of Corte de Pedra

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meglumine antimoniate

Drug

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

Other names: Glucantime

Primary outcomes

  1. Clinical cure

    Time frame: Three months after treatment

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

Secondary outcomes

  1. Adverse events rate - day 7

    Time frame: 7th day

    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

  2. Adverse events rate - day 14

    Time frame: 14th day

    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

  3. Total Adverse events rate

    Time frame: 20th day

    Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the whole treatment

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study 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.

Acronym: Sbold

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 8, 2009
Registry last updated
Oct 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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