Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317980
Status:
COMPLETED
Last Update Posted:
2009-01-22
First Post:
2006-04-21
Brief Title:
Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis
Sponsor:
University of Brasilia
Organization:
University of Brasilia
Study Overview
Official Title:
Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania VianniaBraziliensis
Status:
COMPLETED
Status Verified Date:
2009-01
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:
Lowdosesb
Brief Summary:
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis The study will be done in a field clinic in the state of Bahia Brazil
Detailed Description:
The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate The treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent Recently some research developed in Brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen That evidence has been obtained in patients from the State of Rio de Janeiro who were infected by Leishmania Viannia braziliensis The purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by Leishmania Viannia braziliensis living in a rural area of the State of Bahia Brazil where cutaneous leishmaniasis is highly endemic The usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs
The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes
Meglumine antimoniate calculated dose based on the concentration of pentavalent antimony 5 mgkgd intravenous for 20 days
Meglumine antimoniate calculated dose based on the concentration of pentavalent antimony 15 mgkgd intravenous for 20 days
The clinical outcomes of cure or failure will be evaluated until the third month of follow-up
The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes
Meglumine antimoniate calculated dose based on the concentration of pentavalent antimony 5 mgkgd intravenous for 20 days
Meglumine antimoniate calculated dose based on the concentration of pentavalent antimony 15 mgkgd intravenous for 20 days
The clinical outcomes of cure or failure will be evaluated until the third month of follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None