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

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Malaria, Cerebral
Interventions
DRUG

inhaled nitric oxide

Study drug will be administered using an INOpulse delivery system that delivers small pulses of study drug to the patient via a nasal cannula. Subjects randomized to the intervention arm will receive a dose equivalent to 80 ppm iNO in air for 24 hours per day for a minimum of two days and until clinical improvement (coma recovery), death or a maximum of 5 days.

DRUG

Placebo

The placebo will be administered using an INOpulse delivery system that delivers small pulses of study drug to the patient via a nasal cannula. Subjects randomized to the placebo arm will receive nitrogen in air for 24 hours per day for a minimum of two days and until clinical improvement (coma recovery), death or a maximum of 5 days.

Trial Locations (1)

Unknown

Mbarara Regional Referral Hospital, Mbarara

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Mbarara University of Science and Technology

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

Harvard Medical School (HMS and HSDM)

OTHER

collaborator

Medecins Sans Frontieres, Netherlands

OTHER

lead

Epicentre

OTHER

NCT01388842 - Evaluation of the Efficacy and Safety of Inhaled Nitric Oxide as Adjunctive Treatment for Cerebral Malaria in Children | Biotech Hunter | Biotech Hunter