Assessing new Paediatric tablet of Primaquine as radical cure in Ethiopia

Phase 2

Not yet recruiting

• Conditions: Malaria

• Registration Number: PACTR202110493521020
• Lead Sponsor: The Masters and Scholars of the University of Oxford University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-03
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Those living within 20 km of the catchment of the health facility with a traceable address or phone contact number
2.Parent/legal guardian is willing to comply with the study protocol and visit schedule, including attendance in person for all necessary visits at study site
3. Able to give assent for patients aged 12 – 16 years and Parental/legal guardian informed written consent
4.Age = 6 months and < 16 years at the time of consent
5.Weight = 5.0 kg
6.Slide-confirmed P. vivax mono- or mixed infections
7.Axillary temperature = 37.5º C or history of fever during the previous 10 days
8Ability to swallow oral medication

Exclusion Criteria

1. General danger signs or symptoms of severe malaria
2.Haemoglobin (Hb) <5 g/dL
3. Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, COVID-19, severe diarrhoea with dehydration)
4. COVID-19 positive by a lateral flow antigen test
5. Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease)
6. History of hypersensitivity to study or rescue medication in this study
7. Taking regular medication which may interfere with antimalarial PK or efficacy
8. Severe malnutrition in a child aged between 6-59 months as defined by the presence of symmetrical oedema involving at least the feet or a mid-upper arm circumference < 115 mm
9. Known pregnancy or UPT positive at the screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified