Status:
COMPLETED
Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis
Lead Sponsor:
Hospital Universitário Professor Edgard Santos
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Bahia
Conditions:
Leishmaniasis
Leishmaniasis, Cutaneous
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the treatment of Cutaneous...
Detailed Description
The treatment of cutaneous leishmaniasis caused by L. braziliensis in Brazil with pentavalent antimony is associated with a high rate of failure, reaching up to 45% of cases. Additionally, pentavalent...
Eligibility Criteria
Inclusion
- Newly diagnosed (untreated) cutaneous leishmaniasis or early 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.
Exclusion
- Aspartate aminotransferase, alanine aminotransferase \>3 times upper limit of normal range
- Serum creatinine or blood urea nitrogen \>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
- 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
- Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
- Anticipated non-availability for study visits/procedure
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03294161
Start Date
December 1 2014
End Date
June 1 2017
Last Update
September 26 2017
Active Locations (1)
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1
Corte de Pedra Health Post
Corte de Pedra, Estado de Bahia, Brazil, 40000