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โ† Trials
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Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine

RecruitingPhase 2Ages 12 Years - anyAllFundacion Nacional de Dermatologia
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In plain words

What the trial is, and whether it could suit you

This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Gender: Male or female * Age: \>12 yrs of age * Weight: \> 45 kg * Consent: Prior to any investigations * Mucosal disease: Involvement of the nares, nasal mucosa, palate, pharynx, larynx according to the ENT specialist. * Parasitology: Parasitological confirmation of the lesion (s) will be made by visualization of Leishmania, culture of Leishmania, or molecular identification of Leishmania (PCR) from the biopsy or aspirate of the lesion (s); or a positive Leishmanin skin test plus a scar characteristic of cutaneous leishmaniasis, plus the epidemiologic antecedent of living now or in the past, in an endemic area. Exclusion Criteria: * Previous treatment for leishmaniasis: No specific or putatively specific therapy (Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol) in the last 12 months. Patients may have been previously treated with the agents under investigation---miltefosine, pentamidine---if that treatment ended more than 12 months ago and the disease has not diminished in the last 6 months. * Other diseases: Concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment. * Laboratory : Values of complete blood count, liver function (AST, ALT, alkaline phosphatase), renal function (creatinine, BUN), pancreatic function (lipase), or uric acid beyond 1.5 x Normal Range and that in the PI's opinion would be clinically meaningful. * EKG: Clinically significant abnormalities. * Contraception: Women of childbearing age are required to practice reproductive contraception for 5 months after initiating therapy: abstinence or effective contraception defined as 2 forms of contraception \[a barrier method (diaphragm, condom, or cervical cap with spermicidal foam, gel, or cream) plus a 2nd barrier method or hormonal contraceptive or intrauterine device\] from day 1 through 5 months post therapy.
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What it tests

  • Miltefosine Oral Capsule
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Where

1 site
Hospital de Clinicas
La Paz, Bolivia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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