Effect of Paracetamol on Kidney Function in Severe Malaria
Evaluating the Renoprotective Effect of Paracetamol in Paediatric Severe Malaria: a Randomised Controlled Trial
This study tests if giving paracetamol can help protect the kidneys of children aged 1 to 14 who are suffering from severe malaria.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 1 Year to 14 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Kinshasa, Congo) |
| Trial ID | NCT04251351 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of paracetamol in reducing kidney dysfunction caused by oxidative damage in children suffering from severe falciparum malaria. It is a randomized, open-label, parallel-group, controlled trial that focuses on pediatric patients aged 1 to 14 years who exhibit severe symptoms of malaria. The study aims to understand the role of cell-free hemoglobin-mediated oxidative stress in kidney injury and assess whether paracetamol can mitigate this damage. Participants will be monitored for kidney function and other health outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 to 14 years diagnosed with severe P. falciparum malaria.
Not a fit: Patients with mild malaria or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney protection and reduced mortality in children with severe malaria.
How similar studies have performed: Other studies have indicated the potential for paracetamol to provide renal protection in similar contexts, but this specific approach in pediatric severe malaria is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or Female, patients aged 1 to ≤ 14 years 2. Severe P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or positive PfHRP2 rapid diagnostic test (RDT). Pre-specified modified criteria for severe falciparum malaria Upon hospital admission, asexual parasitaemia plus at least ONE of the following: * Glasgow coma score \< 11/15 or Blantyre coma score \<3/5 in pre-verbal children * Generalized convulsions (≥2 in 24 hours) * Jaundice (visible jaundice) * Severe anaemia (HCT \<15%/Hb\<5 g/dL: aged \<12) Severe anaemia (HCT \<20%/Hb\<7 g/dL: aged ≥12) * Hyperparasitaemia (\>10%) * Hypoglycaemia (glucose \< 2.2 mmol/L; \<40 mg/dL) * Kidney dysfunction (blood urea \> 20 mmol/L) * Acidosis (venous bicarbonate \<15 mmol/L or base excess less than -3.3mEq/L) * Venous lactate \> 5 mmol/L * Shock (systolic blood pressure \< 70 mmHg (\<12 years) \<80 mmHg (≥12 years) with cool extremities or capillary refill \>3 seconds) * Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate\>ULN for age) * Spontaneous bleeding * Prostration (inability to set upright, or drink)\* Abbreviations: HCT, haematocrit; Hb, haemoglobin; \*cannot be only severity criteria 3. Temperature \>38°C on admission or fever during the preceding 48 hours. 4. Less than 24 hours of antimalarial therapy 5. Attending caregiver of participant willing and able to give informed consent for participation in the study Exclusion Criteria: The participant may not enter the trial if ANY of the following apply: 1. Contraindication or known allergy to paracetamol 2. Known chronic liver disease or tender hepatomegaly 3. Known chronic kidney disease, history of renal replacement therapy or renal biopsy 4. Participants who are already enrolled in another research trial involving an investigational product or have participated to the same study before
Where this trial is running
Kinshasa, Congo
- The Kinshasa Medical Oxford Research Unit (KIMORU) — Kinshasa, Congo, Congo, The Democratic Republic of the (Recruiting)
Study contacts
- Principal investigator: Katherine Plewes, Dr. — Mahidol Oxford Tropical Medicine Research Unit
- Study coordinator: Katherine Plewes, Dr.
- Email: katherine@tropmedres.ac
- Phone: +1-604-603-4033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.