Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
This trial is active, not recruiting.
|Phase||phase 2/phase 3|
|Sponsor||Paulo Roberto Lima Machado|
|Collaborator||Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)|
|Start date||January 2011|
|End date||January 2014|
|Trial size||164 participants|
|Trial identifier||NCT01381055, LCPX2011|
The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Cure rate or complete cicatrization of the ulcer.
time frame: 6 months
Initial cure rate or complete cicatrization of the ulcer
time frame: 2 months
Male or female participants from 18 years up to 65 years old.
- Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
- Number of lesions: 1 to 3 ulcerative lesions.
- Lesion´s diameter: 1 to 5 cm.
- Disease duration: up to three months.
- Safety concerns:
- AST, ALT >3 times upper limit of normal range
- Serum creatinine or BUN >1.5 times upper limit of normal range
- Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
- Immunodeficiency or antibody to HIV
- Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
- Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
- Lack of suitability for the trial:
- Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
- Any history of prior anti-leishmania therapy
- Any condition which compromises ability to comply with the study procedures
- Administrative reasons:
- Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
- Anticipated non-availability for study visits/procedures
|Official title||Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis|
|Principal investigator||Paulo Roberto L Machado, MD, PhD|
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