Primaquine in African Children: PAC study

Phase 3

Completed

• Conditions: ncomplicated falciparum Malaria, G6PD deficiency, Single low dose primaquine (SLDPQ); Infections and Infestations; Uncomplicated falciparum Malaria, G6PD deficiency, Single low dose primaquine (SLDPQ)

• Registration Number: ISRCTN11594437
• Lead Sponsor: The University of Oxford

Brief Summary

2018 Other publications in https://pubmed.ncbi.nlm.nih.gov/29347975/ Age-based dosing regimen development (added 21/10/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36462528/ (added 05/12/2022) 2023 Results article in https://doi.org/10.1186/s12916-023-03105-0 (added 20/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-09
• Study Completion: 2020-11-02
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1137

Inclusion Criteria

1. Aged six months to 11 years old
2. Clinically uncomplicated disease
3. Fever (= 37.5°C aural) or history of fever within the previous 72 hours
4. Positive malaria RDT (Uganda only)
5. Positive malaria slide for P. falciparum (mono or mixed infection) of any parasitaemia (Kinshasa only)
6. Informed consent provided by patient or relative/legal guardian

Exclusion Criteria

1. Malaria danger signs, sign(s) of severe malaria, or decompensated anaemia, including: an inability to take or retain fluids or oral medications, confusion, prostration, convulsions, respiratory distress, passing of red or cola-coloured urine (putative blackwater fever”)
2. Severe anaemia (Hb <6 g/dL)
3. Comorbid illness that requires treatment in hospital (physician’s judgement)
4. Patients on drugs known to cause haemolysis in G6PDd e.g. dapsone, nalidixic acid
5. Known to be allergic to PQ, AL, or DHAPP
6. Previous enrolment in the current trial or current enrolment in another trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified