Evaluation of the Efficacy and Safety of Inhaled Nitric Oxide as Adjunctive Treatment for Cerebral Malaria in Children

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess if adding inhaled Nitric Oxide to other malaria treatments can improve the outcome of cerebral malaria in children aged 2months to 12 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epicentre
• Collaborators: Harvard Medical School; Harvard Medical School (HMS and HSDM); Massachusetts General Hospital; Mbarara University of Science and Technology; Medecins Sans Frontieres, Netherlands
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Age between 2 months and 12 years.

• With malaria infection confirmed by a malaria antigen test and/or a positive blood smear examination

• AND sustained coma: achieving a Blantyre Coma Score less than 3 for 2, or more, hours after ruling out and treating hypoglycemia (blood glucose less than 2.2 mmol/l), ruling out meningitis, and ruling out and treating active clinical seizures.

Exclusion Criteria:

• Refusal to participate

• Other cause of coma (toxic or pre-existing severe neurological disease)

• Terminal respiratory failure (due to brainstem coning)

• Coagulopathic

• Clinically unstable enough to preclude venipuncture and phlebotomy

• Severe malnutrition defined by edema or a weight-for-height minus 3 SD;

• Evidence of pre-existing brain injury

• Advanced AIDS defined by WHO clinical staging 4;