Effect of Paracetamol on Kidney Function in Severe Malaria

Launched by UNIVERSITY OF BRITISH COLUMBIA · Jan 29, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether paracetamol can help protect the kidneys of children suffering from severe malaria. Severe malaria can cause serious complications, including damage to the kidneys, particularly when the body is overwhelmed by the malaria parasite. The study aims to find out if giving paracetamol can reduce kidney problems caused by the severe effects of the disease.

To be eligible for this trial, children aged 1 to 14 years who have been diagnosed with severe falciparum malaria may participate. They must show certain signs of severe illness, such as confusion, jaundice (yellowing of the skin), severe anemia, or kidney dysfunction, among other criteria. Participants will be closely monitored during the trial, and their caregivers will need to provide consent for their involvement. It's important to note that children with certain health conditions, like liver disease or severe kidney problems, cannot join the study. This research is currently looking for participants, and it hopes to provide valuable insights into treating severe malaria in young patients.

Gender

ALL

Eligibility 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