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Aggressive Antipyretics for Fever Reduction in CNS Malaria

NCT03399318 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2024-03-05

Study results available
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Summary

The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.

Conditions

Interventions

DRUG

Acetaminophen

30 mg/kg load then 15mg/kg Q6 hours for the Aggressive Antipyretic Arm Acetaminophen is also given to children in the placebo arm when they have a fever over 38.5 degrees Celsius during scheduled clinical assessments

DRUG

Ibuprofen

10 mg/kg Q6 hours for the Aggressive Antipyretic Arm

DRUG

placebo for acetaminophen

placebo for acetaminophen for children in the Usual Care arm For children in the Aggressive Antipyretic Arm, when they have a temperature over 38.5 degrees Celsius they are treated with a placebo

DRUG

placebo for ibuprofen

placebo for ibuprofen

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • Gretchen L Birbeck, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2022-12-02
Completion
2022-12-02

Countries

  • Malawi
  • Zambia

Study Locations

More Related Trials

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 NCT03399318 on ClinicalTrials.gov