Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Brasilia
About this trial
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
Eligibility criteria
Qualifiers
Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis
Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase
Agree and sing informed consent form
Disqualifiers
Previous treatment with leishmanicidal drugs in the last 6 months
Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms)
Serum creatinine or urea 1.5 times the upper limit of normal
Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus
Trial design
Treatments tested in this trial
- Miltefosine 50mg
- Pentoxifylline 400mg
- Liposomal Amphotericin B
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov