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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Miltefosine 50mg
DrugOral Miltefosine 50mg bid
Pentoxifylline 400mg
DrugOral Pentoxifylline 400mg tid
Liposomal Amphotericin B
DrugIntravenous 25 to 40mg/kg
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Oral Miltefosine and Pentoxifylline for Cutaneous LeishmaniasisExperimental treatment 2 interventions
Group B: Oral Miltefosine and Pentoxifylline for Mucous LeishmaniasisExperimental treatment 2 interventions
Group C: Intravenous Liposomal Amphotericin B for Cutaneous LeishmaniasisActive comparator 1 intervention
Group D: Intravenous Liposomal Amphotericin B for Mucous LeishmaniasisActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cure
Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)
Time frame
90 days after the begin of treatmentSecondary outcomes
1
Adverse effects
Presence laboratorial or clinica changes during treatment that lead to treatment interruption
Time frame
30 days after drug interruptionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov