Prophylactic Antimalarial Activity of DB289 in Volunteers
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Prophylactic Antimalarial Activity of DB289 in Volunteers Challenged With Plasmodium Falciparum|
- 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 methods,
- Appendix II).
- To distinguish the mechanism of prophylaxis: causal vs suppressive
- To evaluate the pharmacokinetics of DB289 and DB75
- To assess the safety of DB289
|Study Start Date:||November 2006|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
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 methods,Appendix 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408369
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21205-2186|
|Principal Investigator:||Theresa A. Shapiro, MD, PhD||Johns Hopkins University|