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Effect of Paracetamol on Kidney Function in Severe Malaria

NCT04251351 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2023-06-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Paracetamol

Paracetamol 15 mg/kg/dose IV 6 hourly for 72 hours

PROCEDURE

Mechanical antipyresis

Mechanical antipyresis (i.e. loose clothing, tepid sponging, fanning and cooling blanket) if fever in the first 72 hours. If a temperature \>38.5°C persists despite mechanical antipyresis, or if deemed necessary by the treating clinician, then paracetamol can be administered according to local practice (paracetamol IV 15 mg/kg as needed).

Sponsors & Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • Kinshasa Medical Oxford Research Unit

    collaborator UNKNOWN

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Katherine Plewes, Dr. · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2024-06-01
Completion
2025-11-01

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04251351 on ClinicalTrials.gov