Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214643
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2005-09-11
Brief Title:
Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children
Sponsor:
Albert Schweitzer Hospital
Organization:
Albert Schweitzer Hospital
Study Overview
Official Title:
A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2009-02
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:
There is a necessity for the development of new malaria drugs Some antibiotics are also effective against malaria parasites Fosmidomycin is an antibiotic that has been shown to be effective against malaria although it cannot achieve a total cure in all patients Previous small studies have shown that in combination with clindamycin an commonly used antibiotic it is highly effective and safe when given for three days leading to a total cure in most patients The current study will evaluate its efficacy in a larger population in Gabon and compare its effect with the generally used drug sulfadoxine-pyrimethamine
Detailed Description:
Fosmidomycin-clindamycin 30 mgkg and 10 mgkg given twice daily for three days is an effective and safe combination of antibiotics which demonstrated good activity against malaria parasite in previous phase II studies in African children In this phase III trial the efficacy and safety of the combination will be evaluated in African children with uncomplicated P falciparum malaria A single dose of sulfadoxine-pyrimethamine the standard antimalarial in Gabon is used as comparator
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