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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00818818
Other study ID # lowdoseaging
Secondary ID
Status Completed
Phase Phase 4
First received January 6, 2009
Last updated October 7, 2010
Start date August 2008
Est. completion date April 2010

Study information

Verified date October 2010
Source University of Brasilia
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date April 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Meglumine antimoniate
5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days

Locations

Country Name City State
Brazil Health Center Unit of Corte de Pedra Corte de Pedra, Presidente Tancredo Neves Bahia State

Sponsors (1)

Lead Sponsor Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical cure Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation) Three months after treatment No
Secondary Adverse events rate - day 7 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 7th day Yes
Secondary Adverse events rate - day 14 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 14th day Yes
Secondary Total Adverse events rate Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the whole treatment 20th day Yes