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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00818818 |
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Date of registration:
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06/01/2009 |
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Primary sponsor: |
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Public title:
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Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients
Sbold |
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Scientific title:
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Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial. |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00818818 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Gustavo Adolfo S Romero, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine, University of Brasilia |
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Name:
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Julia S Ampuero-Vela, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine, University of Brasilia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 65 years
- Permanent residence in the endemic area
- Availability of a caregiver for dependent patients
Exclusion Criteria:
- Mucosal disease caused by leishmaniasis
- Disseminated cutaneous disease
- Severe cardiac, renal or hepatic disorders
- Active cancer
- Active tuberculosis
- Leprosy
- HIV positive
- Total bilirubin > 1.5mg/dL
- Urea and creatinin > 1.5 times the upper normal level
- Alkaline phosphatase and aminotransferases > 2.5 times the upper normal level
- Lipase and amylase > 1.5 the upper normal level
- Hemoglobin < 5 g/dL of
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Localized Cutaneous Leishmaniasis
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Intervention(s)
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Drug: Meglumine antimoniate
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Primary Outcome(s)
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Clinical cure
[Time Frame: Three months after treatment]
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Secondary Outcome(s)
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Adverse events rate - day 14
[Time Frame: 14th day]
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Adverse events rate - day 7
[Time Frame: 7th day]
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Total Adverse events rate
[Time Frame: 20th day]
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Secondary ID(s)
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lowdoseaging
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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