Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118807
Status:
COMPLETED
Last Update Posted:
2006-01-09
First Post:
2005-07-01
Brief Title:
Trial of the Effectiveness of AQAS SPAQ and SPCQ for Uncomplicated Malaria in Gambian Children
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Randomized Trial of the Effectiveness of Amodiaquine-Artesunate Amodiaquine-Sulfadoxine-Pyrimethamine and Chloroquine-Sulfadoxine-Pyrimethamine for Treatment of Uncomplicated Malaria in Gambian Children
Status:
COMPLETED
Status Verified Date:
2003-06
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 trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings without supervision of doses other than the first dose
Detailed Description:
Children aged 05-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with ASAQ SPAQ or SPCQ A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the childs parent to be administered at home unsupervised by the study team Patients will be visited at home three days later Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume PCV and malaria microscopy The primary endpoint is clinical failure by day 28 Analysis will be by intention to treat
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 |
|---|---|---|---|
| MRC SCC No 940 | None | None | None |