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Nitrite Infusion in Children With Malaria

NCT04289558 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-03-16

No results posted yet for this study

Summary

The purpose of this study is to assess the safety of intravenous sodium nitrite in African children who have moderately severe malaria.

Conditions

  • Falciparum Malaria

Interventions

DRUG

Sodium Nitrite

Single 60 minute infusion at 1 of 4 sequential dose levels (0.16, 0.32, 0.64 and 1.28 mcg/kg/minute). The dose amount will depend on when the participant enters the study

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Duke University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-10-01
Completion
2021-10-01
FDA Drug
Yes

Countries

  • Tanzania

Study Locations

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Entities

Companies

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 NCT04289558 on ClinicalTrials.gov