Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217451
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-12
Brief Title:
Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin
Sponsor:
Albert Schweitzer Hospital
Organization:
Albert Schweitzer Hospital
Study Overview
Official Title:
Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2005-09
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:
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 A previous small study has shown that in combination with clindamycin an commonly used antibiotic it is highly effective and safe in asymptomatic carriers of malaria parasites The current study will evaluate the efficacy and safety of the combination given for three days in children with uncomplicated malaria in Gabon
Detailed Description:
The treatment of malaria is becoming increasingly difficult due to the development of Plasmodium falciparum strains resistant to commonly used antimalarials Fosmidomycin was shown to be well tolerated and fast-acting in paediatric outpatients and adults but late recrudescences preclude its use as monotherapy Clindamycin was identified as a suitable combination partner following the demonstration of synergistic inhibition of plasmodial growth by in vitro and animal studies
In this study the safety and efficacy of fosmidomycin-clindamycin 30 mgkg plus 10 mgkg twice daily for three days is assessed in children with acute uncomplicated P falciparum malaria
In this study the safety and efficacy of fosmidomycin-clindamycin 30 mgkg plus 10 mgkg twice daily for three days is assessed in children with acute uncomplicated P falciparum malaria
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