Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255567
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2005-11-16
Brief Title:
EfficacySafety of Sodium Stibogluconate SSG Versus Paromomycin PM and SSGPM Combination to Treat V Leishmaniasis
Sponsor:
Drugs for Neglected Diseases
Organization:
Drugs for Neglected Diseases
Study Overview
Official Title:
A Multicentre Comparative Trial of Efficacy and Safety of Sodium Stibogluconate SSG Versus Paromomycin PM Versus Combination of SSG and PM as the First Line Treatment for Visceral Leishmaniasis in Ethiopia Kenya and Sudan
Status:
COMPLETED
Status Verified Date:
2016-03
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:
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL
Detailed Description:
Currently in the three countries Sudan Kenya and Ethiopia many of the patients present themselves in remote areas and need to be treated in relative resource poor settings It is for this reason that standardised treatment with proven efficacy is much needed A shorter course of treatment is not only advantageous for the patient but also reduces the overall case load in the clinics thus reducing the risk of disease outbreaks in already immuno-compromised kala-azar patients Paromomycin either alone or in combination with SSG would decrease the treatment duration substantially An additional added value of combination therapy is that it is likely to reduce the chances of development of parasite resistance against the individual drugs
Leishmaniasis experts in the three countries are in agreement that there are potential benefits of the combination treatment of SSG and PM and that its efficacy should be evaluated with the view to introduce this protocol if proven efficacious and safe There is ample circumstantial evidence of the use of this combination therapy and its efficacy and tolerability as a standardized protocol This can only be confirmed through a randomised controlled study with 6 months follow up
Leishmaniasis experts in the three countries are in agreement that there are potential benefits of the combination treatment of SSG and PM and that its efficacy should be evaluated with the view to introduce this protocol if proven efficacious and safe There is ample circumstantial evidence of the use of this combination therapy and its efficacy and tolerability as a standardized protocol This can only be confirmed through a randomised controlled study with 6 months 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