Chloroquine (CQ) and Azithromycin (AZ) Combination for Malaria Prophylaxis

  • STATUS
    Not Recruiting
  • participants needed
    23
  • sponsor
    U.S. Army Medical Research and Materiel Command
Updated on 23 January 2021
chloroquine
chmi
malarone
atovaquone-proguanil

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.

Description

This study is a Phase 2, open-label study of the combination of a single dose-level of AZ (Zithromax) plus CQ given weekly as a prophylaxis against CQ-resistant P falciparum in healthy adults. After signing informed consent, subjects will undergo screening procedures between Day -77 to Day -18. If enrolled, subjects who are still eligible at Study Day -18 will be randomized to either the CQ/AZ group (Group 1 of 15 subjects: 2 g AZ (Zithromax) plus 300 mg CQ base weekly for 6 weeks), or the CQ control group (Group 2 of 8 subjects: 300 mg chloroquine base weekly for 6 weeks) and start intervention on Study Day -17. The rationale for the CQ control group to receive CQ is to show that the strain utilized (7G8) is indeed chloroquine resistant in humans: we expect all of the subjects in the CQ control group to become symptomatically parasitemic. If 3 or more subjects in the CQ control group do not become symptomatic with malaria, the CHMI will be considered uncontrolled either due to 7G8 not being CQ-resistant, or the parasite not being infective.

Details
Condition Malaria Vaccines, Malaria
Treatment Chloroquine-Azithromycin (CQ/AZ), Chloroquine (CQ), atovaquone-proguanil (Malarone®)
Clinical Study IdentifierNCT03278808
SponsorU.S. Army Medical Research and Materiel Command
Last Modified on23 January 2021

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