Ethiopia P. vivax and P. falciparum in-vivo Effectiveness Study 2021-22

Phase 4

Recruiting

• Conditions: Malaria

• Registration Number: PACTR202110520435408
• Lead Sponsor: ICAP at Columbia University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-31
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

• Those living within 20 km of the catchment of the health facility with a
traceable address or phone contact number
• Volunteer to give their address or phone number and willing to not travel
for the duration of the study
• Volunteer to comply with the study protocol, visit schedule, or get traced in
case defaulted
• Age = 18 years
• Slide-confirmed infection with Pf, with parasitemia of 500-100,000 asexual
forms/µl or slide confirmed infection with Pv with > 250 asexual forms/µl
• For the gametocyte clearance and mosquito feeding endpoints, patients with microscopy-detected gametocytes prior to treatment will be eligible to be enrolled
• Axillary temperature = 37.5º C or history of fever during the previous 24 or
48 hours for Pf and Pv infection, respectively
• Ability to swallow oral medication

Exclusion Criteria

• General danger signs or symptoms of severe malaria
• Mixed Plasmodium infection
• Severe anemia, defined as hemoglobin (Hb) < 7 g/dl
• Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, COVID-19, severe diarrhea with dehydration)
• Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
• Positive pregnancy test or breastfeeding
• Refusal to take a pregnancy test for women of child-bearing age (defined as 18–49 years old or menstruating)
• History of hypersensitivity to study or rescue medication in this study
• Taking regular medication which may interfere with antimalarial pharmacokinetics or efficacy

Study & Design

• Study Type: Interventional
• Study Design: Not specified