Trial · NCT05478720
DON in Pediatric Cerebral Malaria
NCT05478720, Phase 1, Phase 2, Recruiting, Douglas Postels, MD, MS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DON in Pediatric Cerebral Malaria. Trials, record NCT05478720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05478720
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DON in Pediatric Cerebral Malaria
- NCT number
- NCT05478720
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 152 participants, estimated
- Lead sponsor
- Douglas Postels, MD, MS
- Conditions
- Malaria, Cerebral
- Interventions
- 6-diazo-5-oxo-L-norleucine (DON), Placebo, 6-diazo-5-oxo-L-norleucine (DON)
- First posted
- 2022-07-28
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of local AEs occurring within 14 days after the administration of DON | 14 days | Number of AEs |
| Primary | Incidence of systemic AEs occurring within 14 days after the administration of DON | 14 days | Number of AEs |
| Primary | Incidence of systemic SAEs occurring within 14 days after the administration of DON | 14 days | Number of SAEs - pediatric arms only |
| Primary | Assessment of Blantyre Coma Score | 14 days | Time to Blantyre Coma Score of 5 |
| Secondary | PK measurement of DON in sera of recipients measured by half life | Measured through 18 hours post infusion | Measurement of half life |
| Secondary | PK measurement of DON in sera of recipients measured by volume of distribution | Measured through 18 hours post infusion | Measurement of Vd |
| Secondary | PK measurement of DON in sera of recipients measure by maximum concentration (Cmax) | Measured through 18 hours post infusion | Measurement of Cmax |
| Secondary | PK measurement of DON in sera of recipients measure by time of maximal concentration (Tmax) | Measured through 18 hours post infusion | Measurement of Tmax |
| Secondary | PK measurement of DON in sera of recipients measure by area under the concentrations vs. time curve (AUC) | Measured through 18 hours post infusion | Measurement of AUC |
| Secondary | PK measurement of DON in sera of recipients measure by clearance | Measured through 18 hours post infusion | Clearance measured over time |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05478720
GET https://conductscience.org/api/trials/v1/NCT05478720/registered