Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523965
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2007-08-31
Brief Title:
Combination Therapy in Indian Visceral Leishmaniasis
Sponsor:
Banaras Hindu University
Organization:
Banaras Hindu University
Study Overview
Official Title:
A Randomised Open-label Parallel-group Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens Co-administration of AmBisome Paromomycin and Miltefosine in Visceral Leishmaniasis VL
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:
None
Brief Summary:
Rationale
The overall objective of this trial is to identify a safe and effective combination co-administration short course treatment for the treatment of VL which could be easily deployed in a control programme The hypothesis is that the combination treatment is as effective or better than the 5 mgkg single dose of AmBisome and will reduce the risk of parasite resistance occurring Safety and tolerability should be such that the combination can be easily deployed
Objective
The specific primary and secondary objectives are as follows
Primary objective
To identify a short course combination treatment regimen which is at least as effective as a single dose of AmBisome 5mgkg
Secondary objective
To compare safety and tolerability of the various treatments measured by vital signs blood biochemistry renal and liver function tests haematology spontaneous and elicited adverse event reporting
Primary Endpoint
The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6 months post treatment
Parasitology is only carried out at any time during follow-up or at six months post treatment if there are signs or symptoms of VL infection
The overall objective of this trial is to identify a safe and effective combination co-administration short course treatment for the treatment of VL which could be easily deployed in a control programme The hypothesis is that the combination treatment is as effective or better than the 5 mgkg single dose of AmBisome and will reduce the risk of parasite resistance occurring Safety and tolerability should be such that the combination can be easily deployed
Objective
The specific primary and secondary objectives are as follows
Primary objective
To identify a short course combination treatment regimen which is at least as effective as a single dose of AmBisome 5mgkg
Secondary objective
To compare safety and tolerability of the various treatments measured by vital signs blood biochemistry renal and liver function tests haematology spontaneous and elicited adverse event reporting
Primary Endpoint
The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6 months post treatment
Parasitology is only carried out at any time during follow-up or at six months post treatment if there are signs or symptoms of VL infection
Detailed Description:
None
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