Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408369
Status:
COMPLETED
Last Update Posted:
2008-01-29
First Post:
2006-12-04
Brief Title:
Prophylactic Antimalarial Activity of DB289 in Volunteers
Sponsor:
Immtech Pharmaceuticals Inc
Organization:
Immtech Pharmaceuticals Inc
Study Overview
Official Title:
Prophylactic Antimalarial Activity of DB289 in Volunteers Challenged With Plasmodium Falciparum
Status:
COMPLETED
Status Verified Date:
2008-01
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:
To evaluate the prophylactic activity of orally administered DB289 against Plasmodium falciparum in non-immune healthy volunteers who are challenged by the bite of five P falciparum-infected Anopheles stephensi mosquitoes
Detailed Description:
The primary endpoint of this study is the appearance of erythrocytic parasites parasitemia which indicates a prophylaxis failure Parasitemia will be sought by multiple means including blood culture polymerase chain reaction PCR Quantitative Buffy Coat QBC analysis and thick and thin blood smears detailed methodsAppendix II
QBC and giemsa-stained blood smears will be analyzed in real time and a positive result in any one of them is sufficient to initiate chloroquine treatment All positive QBC analyses or blood smears will be confirmed by two experienced observers On smears the location of parasites will be recorded using a stage micrometer and slides will be archived and available for later re-examination PCR samples will be collected and stored for later analysis cultures will be inoculated at once and maintained for 70 days
A positive result in any one of these tests constitutes a drug failure
QBC and giemsa-stained blood smears will be analyzed in real time and a positive result in any one of them is sufficient to initiate chloroquine treatment All positive QBC analyses or blood smears will be confirmed by two experienced observers On smears the location of parasites will be recorded using a stage micrometer and slides will be archived and available for later re-examination PCR samples will be collected and stored for later analysis cultures will be inoculated at once and maintained for 70 days
A positive result in any one of these tests constitutes a drug failure
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