Antimalarial prophylactic efficacy of a weekly dose atovaquone-proguanil

Conditions

Malaria

Brief summary

Efficacy endpoint Proportion of protected volunteers. Protection is defined as the absence of amplifying parasitaemia in the peripheral blood for +21 days following CHMI with PfSPZ Challenge (NF54) in volunteers receiving AP (250/100 mg) for chemoprophylaxis. Amplifying parasitaemia is defined as at least one qPCR result above 20 blood-stage parasites per ML followed by a second qPCR result with an at least 4-fold increased blood stage parasitaemia 24-48 hours apartPrimary safety endpoint Numbe

Detailed description

Secondary safety endpoint Occurrence of any related AE from time of AP/placebo D0 until the end of the study.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMalarone 250/100 mg filmomhulde tabletten

DRUGPfSPZ Challenge (NF54)

DRUGMicrocrystalline cellulose PH102 in capsules (for more informations see IMPD)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Efficacy endpoint Proportion of protected volunteers. Protection is defined as the absence of amplifying parasitaemia in the peripheral blood for +21 days following CHMI with PfSPZ Challenge (NF54) in volunteers receiving AP (250/100 mg) for chemoprophylaxis. Amplifying parasitaemia is defined as at least one qPCR result above 20 blood-stage parasites per ML followed by a second qPCR result with an at least 4-fold increased blood stage parasitaemia 24-48 hours apartPrimary safety endpoint Numbe	—

Measure

Time frame

Efficacy endpoint Proportion of protected volunteers. Protection is defined as the absence of amplifying parasitaemia in the peripheral blood for +21 days following CHMI with PfSPZ Challenge (NF54) in volunteers receiving AP (250/100 mg) for chemoprophylaxis. Amplifying parasitaemia is defined as at least one qPCR result above 20 blood-stage parasites per ML followed by a second qPCR result with an at least 4-fold increased blood stage parasitaemia 24-48 hours apartPrimary safety endpoint Numbe

—

Secondary

Measure	Time frame
Secondary safety endpoint Occurrence of any related AE from time of AP/placebo D0 until the end of the study.	—

Countries

Germany

Outcome results

None listed