Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449040
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-05-28
Brief Title:
Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly
Sponsor:
Hospital Universitário Professor Edgard Santos
Organization:
Hospital Universitário Professor Edgard Santos
Study Overview
Official Title:
Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis CL We selected 28 patients of both sexes aged 60 years or older diagnosed with CL and confirmed by detection of L braziliensis DNA The groups were treated with different total doses of medication G1 12 mgkg G2 18mgkg G3 24 mgkg Clinical and laboratory evaluations were carried out during the period of 180 days D0 D15 D30 D60 D120 D150 and D180
Detailed Description:
The study was carried out through a randomized and double-blind pilot clinical trial with the inclusion of patients treated at the Corte de Pedra Health Center endemic region for Cutaneous Leishmaniasis Twenty-eight patients participated in the study after accepting and signing the Free and Informed Consent Form they were randomized through the list generated electronically by the website wwwrandomizationcom and allocated into three groups
The groups were treated with liposomal amphotericin B AmBisome with three different total doses Group 1 G1 total dose of 12 mgkg 10 patients Group 2 G2 18 mgkg 9 patients Group 3 G3 24 mgkg 9 patients The drug was used twice a week in a hospital outpatient setting Clinical evaluations were performed before starting therapy D0 and at D15 D30 D60 D120 and D180 Laboratory evaluations hemogram BUN Creatinine K ALT AST were determined on D0 D15 and D30 or D60
The groups were treated with liposomal amphotericin B AmBisome with three different total doses Group 1 G1 total dose of 12 mgkg 10 patients Group 2 G2 18 mgkg 9 patients Group 3 G3 24 mgkg 9 patients The drug was used twice a week in a hospital outpatient setting Clinical evaluations were performed before starting therapy D0 and at D15 D30 D60 D120 and D180 Laboratory evaluations hemogram BUN Creatinine K ALT AST were determined on D0 D15 and D30 or D60
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None