Status:
COMPLETED
Inhaled Nitric Oxide for the Adjunctive Therapy of Severe Malaria: a Randomized Controlled Trial
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Makerere University
University of Toronto
Conditions:
Severe Malaria
Eligibility:
All Genders
1-10 years
Phase:
PHASE1
PHASE2
Brief 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 ar...
Detailed Description
Severe malaria remains a major cause of global morbidity and mortality. While the use of artemisinin-based antimalarial therapy has improved outcomes in severe malaria, the mortality rate remains high...
Eligibility Criteria
Inclusion
- Age 1-10 years
- Positive malaria rapid diagnostic test in the presence of any of the features of severe malaria
- Willing and able to complete follow up schedules for the study - 14 day and 6 months after hospital discharge
Exclusion
- Baseline methemoglobinemia
- Known renal, cardiac, or hepatic disease or other chronic illnesses like diabetes, epilepsy, cerebral palsy, clinical AIDS
- Severe malnutrition
- Severe malarial anemia without other signs of severe malaria
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01255215
Start Date
July 1 2011
End Date
January 1 2014
Last Update
February 20 2014
Active Locations (1)
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1
Jinja Regional Referral Hospital
Jinja, Uganda