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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-19
• Last Update Posted: 4 March 2024

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

Name	Time	Method
Adequate clinical and parasitological response

Secondary Outcome Measures

Name	Time	Method
1.Document genetic polymorphisms implicated in antimalarial drug resistance<br>2.Distinguish reinfections and recrudescent infections<br>3.Determine the survival time of Ethiopian parasite isolates in ring-stage assay<br>4.Compare the transmissibility of P. falciparum parasites with delayed and rapid parasite clearance and markers of drug resistance<br>5.Identify genetic changes related to signs of delayed parasite clearance or resistance<br>6.Determine fever, parasite, cytokine, antigen, and antibody clearance rates as measured by microscopy adjusted by 18S-based quantitative PCR<br>7.Assess hematological responses<br>8.Assess pfhrp2/3 gene deletion among P. falciparum-infected patients<br>