Clinical trial NCT00600548: Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)
Official title: Clinical Trial to Assess Efficacy and Safety of Orally Administered Miltefosine in Brazilian Patients With Cutaneous Leishmaniasis Compared to the Standard Care as Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment of Cutaneous Leishmaniasis in Brazil.
Keywords: Cutaneous leishmaniasis
Miltefosine
Meglumine antimoniate
L. braziliensis, L. guyanensis
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Ministerio de Ciencia e Innovación, Spain
name: Ministry of Health, Brazil
name: AEterna Zentaris
First posted: 2008-01-25
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 5 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.

Exclusion Criteria:

Safety concerns:

* Thrombocyte count \<30 x 109/l
* Leukocyte count \<1 x 109/l
* Hemoglobin \<5 g/100 ml
* ASAT, ALAT, AP \>3 times upper limit of normal range
* Bilirubin \>2 times upper limit of normal range
* Serum creatinine or BUN \>1.5 times upper limit of normal range
* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
* Immunodeficiency or antibody to HIV
* Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months

Lack of suitability for the trial:

* Negative parasitology (aspirate/smear)or negative Montenegro test
* Any history of prior anti-leishmania therapy
* Any condition which compromises ability to comply with the study procedures
* Concomitant serious infection other than cutaneous

Administrative reasons:

* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedures

Primary outcomes:
measure: Cure rate or complete cicatrization of the ulcer.
timeFrame: 6 months after treatment.
Secondary outcomes:
measure: Inicial cure rate or complete cicatrization of the ulcer.
timeFrame: 2 months after treatment.
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Fundação de Medicina Tropical do Amazonas
state: Amazonas
city: Tancredo Neto
country: Brazil
facility: Posto de Saúde de Corte de Pedra
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Paulo RL Machado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machado PR, Ampuero J, Guimaraes LH, Villasboas L, Rocha AT, Schriefer A, Sousa RS, Talhari A, Penna G, Carvalho EM. Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. PLoS Negl Trop Dis. 2010 Dec 21;4(12):e912. doi: 10.1371/journal.pntd.0000912.