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Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

This study has been completed.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ministério de Ciência e Tecnologia
Ministério da Saúde
Zentaris Gmb H
Information provided by:
Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT00600548
First received: January 2, 2008
Last updated: April 14, 2010
Last verified: March 2010
History of Changes

January 2, 2008
April 14, 2010
July 2007
March 2009   (final data collection date for primary outcome measure)
Cure rate or complete cicatrization of the ulcer. [ Time Frame: 6 months after treatment. ] [ Designated as safety issue: Yes ]

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.
Cure rate or complete cicatrization of the ulcer. [ Time Frame: 6 months after treatment. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00600548 on ClinicalTrials.gov Archive Site
Inicial cure rate or complete cicatrization of the ulcer. [ Time Frame: 2 months after treatment. ] [ Designated as safety issue: Yes ]

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.
Inicial cure rate or complete cicatrization of the ulcer. [ Time Frame: 2 months after treatment. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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®).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Treatment of Cutaneous Leishmaniasis in Brazil.
  • Drug: Miltefosine.
    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.
    Other Name: Impavido.
  • Drug: Meglumine antimoniate.
    Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
    Other Name: Glucantime.
  • Experimental: 1.1
    Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
    Intervention: Drug: Miltefosine.
  • Active Comparator: 1.2
    Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
    Intervention: Drug: Meglumine antimoniate.
  • Experimental: 2.1
    Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
    Intervention: Drug: Miltefosine.
  • Active Comparator: 2.2
    Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).
    Intervention: Drug: Meglumine antimoniate.
Machado PR, Ampuero J, Guimarães 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
July 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
2 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00600548
D-18506, 410559/2006-7
Yes
Paulo Roberto Lima Machado, Universidade Federal da Bahia
Hospital Universitário Professor Edgard Santos
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Ministério de Ciência e Tecnologia
  • Ministério da Saúde
  • Zentaris Gmb H
Principal Investigator: Paulo RL Machado, MD, PhD Federal University of Bahia
Hospital Universitário Professor Edgard Santos
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP