None listed
Conditions
Interventions
Group 1 Type of group
The study will include 40 patients diagnosed with mucocutaneous leishmaniasis (non-pregnant men and women aged 18 years and older) whose therapeutic indication will be to receive amphotericin B at the conventional dose of 50 mg / day, completing a cumulative dose of 1550 mg. The study will be carried out at the tropical medicine institute Alexander Von Humboldt, Peruvian University Cayetano Heredia, Lima-Peru. The random sequence will be balanced in twenty blocks of two. All patients will consum
Sponsors
UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of mucocutaneous leishmaniasis confirmed by direct observation of extended biopsies, cultures or other acceptable methods (hamster inoculation, immunofluorescence, POR) Patients with presumptive diagnosis of mucocutaneous leishmaniasis could also be enrolled as long as the discarding of other pathologies has been carried out through the study of biopsies (Tuberculosis, leprosy, paracoccidiodomicosis, lymphoma) Patients can be men or women, who have resided in the jungle zones of Peru, where leishmaniasis is endemic and that have been considered within a therapeutic scheme with Amphotericin B in the tropical medicine institute, Peruvian University Cayetano Heredia in Lima Perú
Exclusion criteria
Exclusion criteria: Pregnancy or lactation Serum creatinine greater than the upper normal limit for age and sex; treatment with an antileishmanial drug (sodium stibogluconate or meglumine antimony) within two weeks prior to enrollment; Concomitant malignancy, active tuberculosis, alcoholism, respiratory failure, congestive heart failure, cirrhosis with ascites, nephrotic syndrome or severe hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:methods of assessment of glomerular filtration Measure:A detailed evaluation of renal function will be obtained at the beginning and at the end of the study: a) the glomerular function will be evaluated with inulin and paraaminohipurate clearance (PAH) with the intention to estimate the glomerular filtration rate (GFR) and plasma renal flow (FRP)®. The fraction of filtration will be calculated as TFG / FRP, b) The tubular integrity will be measured by the presence of N-acetylglucosamine in urine (fluorometric test) and c) The tubular function will be measured with the fractional excretion of sodium and chlorine as well as excretion urinary potassium, plasma and urinary osmolarity and the determination of the transtubular potassium concentration gradient, in addition determination of renal concentration capacity should be measured before starting treatment and one day after the end of the therapeutic course after a water restriction 8 hours Timepoints:between 4 to 8 hours | — |
Outcome results
None listed