Inhaled Nitric Oxide as an Adjunctive Treatment for Cerebral Malaria in Children: A Phase II Randomized Open-Label Clinical Trial

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dc.contributor.authorMwanga-Amumpaire, Juliet
dc.contributor.authorCarroll, Ryan W.
dc.contributor.authorBaudin, Elisabeth
dc.contributor.authorKemigisha, Elisabeth
dc.contributor.authorNampijja, Dorah
dc.contributor.authorMworozi, Kenneth
dc.contributor.authorSantorino, Data
dc.contributor.authorNyehangane, Dan
dc.contributor.authorNathan, Daniel I.
dc.contributor.authorDe Beaudrap, Pierre
dc.contributor.authorEtard, Jean-François
dc.contributor.authorFeelisch, Martin
dc.contributor.authorFernandez, Bernadette O.
dc.contributor.authorBerssenbrugge, Annie
dc.contributor.authorBangsberg, David
dc.contributor.authorBloch, Kenneth D.
dc.contributor.authorBoum, Yap
dc.contributor.authorZapol, Warren M.
dc.date.accessioned2022-08-01T14:31:28Z
dc.date.available2022-08-01T14:31:28Z
dc.date.issued2015
dc.description.abstractChildren with cerebral malaria (CM) have high rates of mortality and neurologic sequelae. Nitric oxide (NO) metabolite levels in plasma and urine are reduced in CM. Methods. This randomized trial assessed the efficacy of inhaled NO versus nitrogen (N2) as an adjunctive treatment for CM patients receiving intravenous artesunate.We hypothesized that patients treated with NO would have a greater increase of the malaria biomarker, plasma angiopoietin-1 (Ang-1) after 48 hours of treatment. Results. Ninety-two children with CM were randomized to receive either inhaled 80 part per million NO or N2 for 48 or more hours. Plasma Ang-1 levels increased in both treatment groups, but there was no difference between the groups at 48 hours (P = not significant [NS]). Plasma Ang-2 and cytokine levels (tumor necrosis factor-α, interferon- γ, interleukin [IL]-1β, IL-6, IL-10, and monocyte chemoattractant protein-1) decreased between inclusion and 48 hours in both treatment groups, but there was no difference between the groups (P = NS). Nitric oxide metabolite levels—blood methemoglobin and plasma nitrate—increased in patients treated with NO (both P < .05). Seven patients in the N2 group and 4 patients in the NO group died. Five patients in the N2 group and 6 in the NO group had neurological sequelae at hospital discharge. Conclusions. Breathing NO as an adjunctive treatment for CM for a minimum of 48 hours was safe, increased blood methemoglobin and plasma nitrate levels, but did not result in a greater increase of plasma Ang-1 levels at 48 hours.en_US
dc.identifier.citationMwanga-Amumpaire, J., Carroll, R. W., Baudin, E., Kemigisha, E., Nampijja, D., Mworozi, K., ... & Zapol, W. M. (2015, September). Inhaled nitric oxide as an adjunctive treatment for cerebral malaria in children: a phase II randomized open-label clinical trial. In Open forum infectious diseases (Vol. 2, No. 3). Oxford University Press. DOI: 10.1093/ofid/ofv111en_US
dc.identifier.other10.1093/ofid/ofv111
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/4241
dc.language.isoenen_US
dc.publisherOxford University Pressen_US
dc.subjectCerebral malariaen_US
dc.subjectMethemoglobinen_US
dc.subjectNitric oxideen_US
dc.subjectPlasmodium falciparumen_US
dc.titleInhaled Nitric Oxide as an Adjunctive Treatment for Cerebral Malaria in Children: A Phase II Randomized Open-Label Clinical Trialen_US
dc.typeArticleen_US
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