Chloroquine (CQ) and Azithromycin (AZ) Combination for Malaria Prophylaxis
Status:
Withdrawn
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
This is an open label, Phase 2 study with controlled human malaria infection (CHMI). Twenty
three subjects will be enrolled into 2 groups (15 subjects in the Chloroquine-Azithromycin
[CQ/AZ] Intervention Group, and 8 subjects in the Chloroquine [CQ] Group). The CQ/AZ Group
will receive experimental intervention of 300 mg of CQ and 2 g of azithromycin (AZ). The CQ
Group will receive 300 mg of CQ only. All subjects will participate in the CHMI and will be
required to stay at a hotel for evaluation for a maximum of 14 nights starting 7 days after
the challenge. A standard dose of atovaquone-proguanil (Malarone®) will be administered to
all symptomatic parasitemic subjects under directly observed treatment.
Phase:
Phase 2
Details
Lead Sponsor:
U.S. Army Medical Research and Development Command U.S. Army Medical Research and Materiel Command
Treatments:
Atovaquone Atovaquone, proguanil drug combination Azithromycin Chloroquine Chloroquine diphosphate Proguanil