UnknownPhase 3

Effect of Paracetamol on Kidney Function in Severe Malaria

Democratic Republic of the Congo460 participantsStarted 2021-12-13

Plain-language summary

A randomised open labeled, parallel-group, controlled trial to assess the efficacy of paracetamol to reduce kidney dysfunction caused by cell-free haemoglobin-mediated oxidative damage in paediatric patients with falciparum malaria complicated by intravascular haemolysis.

Who can participate

Age range1 Year – 14 Years

SexALL

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Inclusion criteria

✓. Male or Female, patients aged 1 to ≤ 14 years
✓. Severe P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or positive PfHRP2 rapid diagnostic test (RDT).
✓. Temperature \>38°C on admission or fever during the preceding 48 hours.
✓. Less than 24 hours of antimalarial therapy
✓. Attending caregiver of participant willing and able to give informed consent for participation in the study

Exclusion criteria

✕. Contraindication or known allergy to paracetamol
✕. Known chronic liver disease or tender hepatomegaly
✕. Known chronic kidney disease, history of renal replacement therapy or renal biopsy
✕. Participants who are already enrolled in another research trial involving an investigational product or have participated to the same study before

What they're measuring

Acute kidney injury (AKI) or death among patients enrolled without AKI (Composite outcome)

Timeframe: during first 7 days of enrolment

Acute kidney injury (AKI) progression or death among patients enrolled with AKI (Composite outcome)

Timeframe: during first 7 days of enrolment

Trial details

NCT IDNCT04251351

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

Contact for this trial

Katherine Plewes, Dr.

+1-604-603-4033 katherine@tropmedres.ac

View on ClinicalTrials.gov More Severe Malaria trials