Localized Cutaneous Leishmaniasis Clinical Trial
— SboldOfficial 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.
| Verified date | October 2010 |
| Source | University of Brasilia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: Ministry of Health |
| Study type | Interventional |
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.
| 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Health Center Unit of Corte de Pedra | Corte de Pedra, Presidente Tancredo Neves | Bahia State |
| Lead Sponsor | Collaborator |
|---|---|
| University of Brasilia |
Brazil,
| 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 |