Assessing how good a single and low dose of primaquine is at stopping the transmission of falciparum malaria between children and mosquitoes and how primaquine is handled by the body

Phase 2

• Conditions: Acute uncomplicated Plasmodium falciparum malaria; Infections and Infestations; Plasmodium falciparum malaria

• Registration Number: ISRCTN16297951
• Lead Sponsor: niversity of Oxford

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39227956/ (added 04/09/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-26
• Last Update Posted: 9 September 2024
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Participant parent/legal guardian is willing and able to give informed consent for participation in the study
2. Aged =6 months and <5 years
3. Weight =5 kg
4. Presentation with fever (axillary =37.5°C, tympanic =38°C) or fever history =24 h and clinically uncomplicated disease
5. P. falciparum parasitaemia 1,000 – 250,000/µl (mono-/mixed Plasmodium species) detected by light microscopy
6. Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule

Exclusion Criteria

1. General danger signs in children under 5 years or signs of severe falciparum malaria according to the definitions of WHO (2000) e.g. prostration, respiratory distress, reduced consciousness
2. Persistent vomiting as given in the history of the current illness
3. P. falciparum (Pf) parasitaemia >250,000/µl (>5% parasitaemia)
4. Haemoglobin (Hb) <5 g/dl
5. Patients on treatment for a significant illness e.g. HIV/AIDS, TB, leprosy or currently taking a drug known to cause haemolysis in G6PDd
6. Known to be allergic to PQ or ASPYR
7. On regular medication, which might interfere with antimalarial pharmacokinetics
8. Antimalarials taken within the last 2 weeks
9. Having taken a herbal medicine within the last 4 weeks
10. Previous participation in a malaria vaccine trial
11. Previous enrolment in the current trial or current enrolment in another trial
12. Severe malnutrition – defined as a mid-upper arm circumference (MUAC) <115 mm
13. Febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal or hepatic diseases, HIV/AIDS)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 28/06/2022:<br>1. Proportions of patients infecting =1 mosquito in the ASPYR arm vs ASPYR+SLDPQ arm assessed by direct membrane feeding on days 0, 1, 2, and 7<br>2. Mean within-person percentage change in mosquito infectivity assessed by direct membrane feeding at baseline and on days 1, 2, 7, and 14<br><br><br>Previous primary outcome measure:<br>1. Proportions of patients infecting =1 mosquito in the ASPYR arm vs ASPYR+SLDPQ arm assessed by direct membrane feeding at days 2, 3, 7 and 14<br>2. Mean within-person percentage change in mosquito infectivity assessed by direct membrane feeding on days 2, 3, 7 and 14 vs baseline