Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)
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
2 other identifiers
interventional
180
1 country
2
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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 2, 2008
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedApril 15, 2010
March 1, 2010
1.7 years
January 2, 2008
April 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure rate or complete cicatrization of the ulcer.
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
6 months after treatment.
Secondary Outcomes (1)
Inicial cure rate or complete cicatrization of the ulcer.
2 months after treatment.
Study Arms (4)
1.1
EXPERIMENTALCutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
1.2
ACTIVE COMPARATORCutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
2.1
EXPERIMENTALCutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
2.2
ACTIVE COMPARATORCutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).
Interventions
Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.
Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitário Professor Edgard Santoslead
- Conselho Nacional de Desenvolvimento Científico e Tecnológicocollaborator
- Ministerio de Ciencia e Innovación, Spaincollaborator
- Ministry of Health, Brazilcollaborator
- AEterna Zentariscollaborator
Study Sites (2)
Fundação de Medicina Tropical do Amazonas
Manaus, Amazonas, Brazil
Posto de Saúde de Corte de Pedra
Tancredo Neto, Estado de Bahia, Brazil
Related Publications (1)
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.
PMID: 21200420DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paulo RL Machado, MD, PhD
Federal University of Bahia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 2, 2008
First Posted
January 25, 2008
Study Start
July 1, 2007
Primary Completion
March 1, 2009
Study Completion
July 1, 2009
Last Updated
April 15, 2010
Record last verified: 2010-03