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Ethiopia In-vivo Drug Efficacy Study 2023

Phase 4
Recruiting
Conditions
Malaria
Registration Number
PACTR202311879488648
Lead Sponsor
Centers for Disease Control and Prevention
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
528
Inclusion Criteria

1. Able to give informed consent, assent and/or parental/guardian permission
2. Age = 6 months
3. Weight = 5.0 kg
4. Hemoglobin = 7 g/dl
5. Axillary temperature = 37.5º C or history of fever during the previous 24 hours
6. Ability to swallow oral medication
7. Slide-confirmed P. falciparum mono-infection with parasite density = 500 parasites per µL.

Exclusion Criteria

1.General danger signs or symptoms of severe malaria
2.Mixed Plasmodium infection
3.Anemia defined as hemoglobin < 7 g/dl
4.Presence of febrile conditions caused by diseases other than malaria
5.Serious or chronic medical condition
6.Pregnant or breastfeeding
7.Refusal to take pregnancy test for women of childbearing age ( 12–49 years)
8.History of hypersensitivity to study or rescue medication in this study
9.Taking regular medication which may interfere with antimalarial pharmacokinetics or efficacy
10.Children weighing less than 5 kilograms
11.Severe malnutrition in children aged between 6-59 months as defined by the presence of symmetrical edema involving at least the feet or a mid-upper arm circumference < 115 mm

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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