Clinical trial

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

Name

RSRB00067717

Description

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.

Trial arms

Trial start

2019-01-07

Estimated PCD

2022-12-02

Trial end

2022-12-02

Status

Completed

Phase

Early phase I

Treatment

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

Arms:

Aggressive Antipyretics

Other names:

Paracetamol

Ibuprofen

10 mg/kg Q6 hours for the Aggressive Antipyretic Arm

Arms:

Aggressive Antipyretics

Other names:

Brufen

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

Arms:

Usual Care

Other names:

Placebo

placebo for ibuprofen

Arms:

Usual Care

Other names:

Placebo

Size

256

Primary endpoint

Mean Maximum Temperature

72 hours

Seizure Severity

72 hours

Eligibility criteria

Inclusion Criteria: * Evidence of Plasmodium falciparum malaria infection by peripheral blood smear or rapid diagnostic test * Central nervous system (CNS) symptoms associated with malaria. CEREBRAL MALARIA (CM): Impaired consciousness with a Blantyre Coma Score (BCS)(73) ≤2 in children under 5 years or a Glasgow Coma score (GCS) ≤10 in children ≥5 years OR CNS MALARIA: Complicated seizure(s), meaning prolonged (\>15 minutes), focal or multiple; or impaired consciousness or other evidence of impaired consciousness (confusion, delirium) without frank coma (BCS\>2, GCS =11-14) Exclusion Criteria: * Circulatory failure (cold extremities, capillary refill \> 3 seconds, sunken eyes, ↓ skin turgor) * Vomiting in the past 2 hours * Serum creatinine (Cr) \> 1.2 mg/dL * A history of liver disease * Jaundice or a total bilirubin of \>3.0mg/dL * A history of gastric ulcers or gastrointestinal bleeding * A history of thrombocytopenia or other primary hematologic disorder * Petechiae or other clinical indications of bleeding abnormalities * A known allergy to ibuprofen, acetaminophen, aspirin or any non-steroidal medication * Any contraindication for nasogastric tube (NGT) placement and/or delivery of enteral medications

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 256, 'type': 'ACTUAL'}}

Updated at

2024-03-05

1 organization

2 products

6 indications

Organization

University of Rochester

Product

Acetaminophen

Indication

Malaria

Indication