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DON in Pediatric Cerebral Malaria

NCT05478720 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-07-31

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria. The main objectives are:

* Determine the pharmacokinetic (PK) profile of a single dose of DON in children with CM
* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with improved intracerebral blood flow dynamics on transcranial doppler (TCD)
* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with CM is associated with a reduction in brain volume score on magnetic resonance imaging (MRI)
* Determine if administration of a single intravenous dose of DON as an adjunctive therapy in children with cerebral malaria is associated with changes in electroencephalogram (EEG) pattern
* Exploratory: Explore the metabolic mechanisms of action of adjunctive DON in children with CM

Healthy adult participants will receive:

* anti-emetic ondansetron
* one dose of DON

Adults with uncomplicated malaria will receive:

* anti-emetic ondansetron
* one dose of DON
* artemisinin-combination therapies per Malawi Ministry of Health guidelines

Pediatric participants will receive:

* one dose of DON
* anti-emetic ondansetron and per Malawi Ministry of Health guidelines:
* enteral lumefantrine-artemether therapy, and
* artesunate therapy

Conditions

  • Malaria, Cerebral

Interventions

DRUG

6-diazo-5-oxo-L-norleucine (DON)

Single intravenous dose ranging from 0.1-10 mg/kg per dose

DRUG

Placebo

Single intravenous dose of saline

DRUG

6-diazo-5-oxo-L-norleucine (DON)

Single intravenous dose ranging from 0.1-1.0 mg/kg per dose

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Douglas Postels, MD, MS

    lead UNKNOWN

Principal Investigators

  • Douglas Postels, MD · Children's National Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Drugs

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 NCT05478720 on ClinicalTrials.gov