NCT01160562 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Crompton PD, Traore B, Kayentao K, Doumbo S, Ongoiba A, Diakite SA, Krause MA, Doumtabe D, Kone Y, Weiss G, Huang CY, Doumbia S, Guindo A, Fairhurst RM, Miller LH, Pierce SK, Doumbo OK
Sickle cell trait is associated with a delayed onset of malaria: implications for time-to-event analysis in clinical studies of malaria. J Infect Dis. 2008 Nov 1;198(9):1265-75. doi: 10.1086/592224.
Langhorne J, Ndungu FM, Sponaas AM, Marsh K
Immunity to malaria: more questions than answers. Nat Immunol. 2008 Jul;9(7):725-32. doi: 10.1038/ni.f.205. Review.
Vekemans J, Ballou WR
Plasmodium falciparum malaria vaccines in development. Expert Rev Vaccines. 2008 Mar;7(2):223-40. doi: 10.1586/14760584.7.2.223. Review.

Pilot Study to Estimate the Burden and Distribution of Plasmodium Falciparum Malaria in Kalifabougou, Mali in Preparation for a Prospective Cohort Study of Naturally-Acquired Malaria Immunity

Details for clinical trial NCT01160562

Clinical trial NCT01160562 - References