Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT00818818
Status:
COMPLETED
Last Update Posted:
2010-10-08
First Post:
2009-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients
Sponsor:
University of Brasilia
Organization:
Study Overview
Official Title:
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.
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sbold
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: