Leishmaniasis
Conditions
Interventions
Group 1 (mucosal active control group): 20 patients with mucosal leishmaniasis treated with 20mgSb+5/kg/day meglumine antimoniate intravenous for 30 days and oral Pentoxifylline 400mg three times dail
Drug
E02.319
V03.175.250
Sponsors
Pós Graduação de Ciências da Saúde - Universidade de Brasília
Pós Graduação de Ciências da Saúde - Universidade de Brasília
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis; ages between 18 and 80 years old; for patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm; fertile female patients should use at least two contraceptive methods (hormonal and barrier); agree to participate in the study and sign the informed consent term.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Use of any leishmanicidal drugs six months prior; clinical or laboratorial evidences of electrocardiographic disorders; renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS; hypersensitivity to meglucamine antimoniate; pregnancy or lactation; Fertile females that do not agree to use contraceptive methods; patients that do not agree to the informed consent term.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Access cure, failure or relapse. Cure being defined by complete healing of previous lesions until the 90th day after the begin of the treatment and non increase or decrease of indirect immunofluorescence title in the blood test; Failure being defined by presence of lesions previously documented that fail to heal until the 90th day after the begin of the treatment or lesions that increased or maintenance or increase in that indirect immunofluorescence title in the blood test; Relapse being defined as lesions that reappear on the scar of a previously healed lesion in the flow up time up to 180 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Access the presence of side effect, verified by alterations on clinical or laboratorial exams higher than the reference value ;Access the need of treatment interruption due to adverse effects and toxicity verified by alterations on clinical or laboratorial exams higher than the reference value | — |
Countries
Brazil
Contacts
Public ContactSofia Martins
Pós Graduação de Ciências da Saúde - Universidade de Brasília
Outcome results
None listed