Inhaled Nitric Oxide for the Adjunctive Therapy of Severe Malaria: a Randomized Controlled Trial
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
Despite the use of highly effective anti-malarial medications, 10-30% of African children
with severe malaria will die, underscoring the need for adjunctive therapies that can be
applied in endemic areas. A clinical trial of adjunctive inhaled nitric oxide (iNO) in severe
malaria is warranted on the basis of firm proof of concept from animal studies and a human
study using the NO donor L-arginine, together with evidence of safety from clinical
experience and trials of iNO for other conditions. Our objective is to determine whether
supplemental iNO (80 ppm) in addition to Ugandan Standard of Care treatment reduces levels of
Angiopoietin-2 (Ang-2), a quantitative biomarker of malaria severity, in children with severe
malaria compared to Standard of Care treatment alone. We will conduct a randomized
placebo-controlled trial among children 1-10 years of age admitted to Jinja Hospital (Uganda)
with severe malaria to test the efficacy of inhaled nitric oxide in severe malaria.