CompletedPhase 4

Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients

Brazil13 participantsStarted 2008-08

Plain-language summary

This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical cure

Timeframe: Three months after treatment

Trial details

NCT IDNCT00818818

SponsorUniversity of Brasilia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

View on ClinicalTrials.gov More Localized Cutaneous Leishmaniasis trials