CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 256 enrolled
Drug / intervention
Acetaminophen +3 moredrug
Likely dose
Acetaminophen 30 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03399318
NCT03399318Phase 2Completed

Aggressive Antipyretics in CNS Malaria: A Randomized-Controlled Trial Assessing Antipyretic Efficacy and Parasite Clearance Effects

University of Rochester·interventional·Posted Jan 16, 2018·Updated Mar 5, 2024

In Brief

A Phase 2 clinical trial evaluating Acetaminophen, Ibuprofen, and 2 other interventions for Malaria and 5 related conditions. Completed, enrolled 256 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalawi, Zambia

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 16, 2018
Enrollment StartJan 7, 2019
Primary CompletionDec 2, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.5 years ago

Interventions

Acetaminophendrug

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

Ibuprofendrug

10 mg/kg Q6 hours for the Aggressive Antipyretic Arm

placebo for acetaminophendrug

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

placebo for ibuprofendrug

placebo for ibuprofen