Prophylactic Antimalarial Activity of DB289 in Volunteers
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|ClinicalTrials.gov Identifier: NCT00408369|
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : January 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Prophylactic Activity Against Malaria||Drug: DB289||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prophylactic Antimalarial Activity of DB289 in Volunteers Challenged With Plasmodium Falciparum|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|