This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis.
Gender: Male or female
Age: >12 yrs of age
Weight: > 45 kg
Consent: Prior to any investigations
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.
Single group
Miltefosine Oral Capsule
DrugMiltefosine 3 pill per day during 28 days AND pentamidine inhaled 300 mg / d during 10 dosis
Efficacy
Clinical Score.Qualification compromise in five places (nose skin, nose mucosa, mouh-palate mucosa, pharynx and larynx usind four signs ( erythema, inflamation, infiltration and ulceration) with this scale: 0= absen5t, 1=mild, 2= moderate and 3= severe. Maximun score: 60
Incidence of Treatment-Emergent Adverse Events
as Measured by the Number of Adverse Drug Reactions. Physical examination data will be listed at screening and at follow up time points. For laboratory data, the values that are below the lower limit or above the upper limit of the normal reference range will be flagged. Those values or changes in values, which are identified as being clinically significant, will be flagged and summarized separately. For physical examination data, any clinically relevant changes
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