Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425763
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2007-01-19
Brief Title:
Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P Falciparum Malaria
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Efficacy of Amodiaquine-artesunate in the Treatment of Symptomatic Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children at an IPTi Site in Rural Western Kenya
Status:
COMPLETED
Status Verified Date:
2012-04
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:
IPTi DRWG
Brief Summary:
We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants IPTitrial in the same area in order to correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria for each regimen
Detailed Description:
We propose to conduct an amodiaquine-artesunate efficacy trial at Bondo District Hospital in Kenya The results will enable us to better interpret the results of the main IPTi trial We will assess the efficacy of a three day course of amodiaquine plus three days of artesunate AQ3AS3 for the treatment of symptomatic uncomplicated P falciparum infections Study subjects are febrile children 6-59 months old with laboratory-confirmed uncomplicated P falciparum infections Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy Children will be followed closely for signs of drug failure or recrudescence and any children failing therapy will be treated with Coartem or if severe with quinine We will also perform drug resistance testing on parasite samples from children with treatment failure The results of this efficacy trial will allow us to assist policymakers in deciding what drugs should be used for IPTi should it be adopted into national policy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KEMRI-SSC-1190 | None | None | None |