Abstract
BackgroundPneumonia is the leading infectious cause of death in children under 5 years of age around the globe. In addition to preventing pneumonia, there is a critical need to provide greater access to appropriate and effective treatment. Studies in Asia have evaluated the effectiveness of 3 days of oral amoxicillin for the treatment of fast-breathing pneumonia; however, further evidence is needed to determine if 3 days of oral amoxicillin is also effective for the treatment of chest indrawing pneumonia.MethodsThis is a double-blind, randomized, non-inferiority trial with the objective to assess the effectiveness of shorter duration amoxicillin dispersible tablet (DT) treatment of chest indrawing childhood pneumonia in a malaria-endemic region of Malawi. The primary objective of this study is to determine whether 3 days of treatment with oral amoxicillin DT in HIV-uninfected Malawian children two to 59 months of age with chest indrawing pneumonia is as effective as 5 days of treatment. The study will enroll 2000 children presenting to Kamuzu Central or Bwaila District Hospitals in Lilongwe, Malawi. Each child will be randomized to either 3 days of amoxicillin DT followed by 2 days of placebo DT or 5 days of amoxicillin DT. Children in the study will be hospitalized for 48 h after enrollment and will have scheduled study visits at Days 2, 4, 6 and 14. Treatment failure by Day 6 is the primary outcome. We hypothesize that the rates of treatment failure will be similar in both arms and that 3 days of treatment will be non-inferior to 5 days of amoxicillin DT for chest indrawing pneumonia using a relative non-inferiority margin of 1.5. This trial was approved by the Western Institutional Review Board and Malawi College of Medicine Research and Ethics Committee.DiscussionGiven the paucity of data from Africa, African-based research is necessary to establish appropriate duration of treatment with amoxicillin DT for chest indrawing childhood pneumonia in malaria-endemic settings in the region. An expanded evidence base will contribute to future iterations of World Health Organization Integrated Management of Childhood Illness guidelines.Trial registrationNCT02678195: Pre-results. Date registered February 9, 2016.
Highlights
Pneumonia is the leading infectious cause of death in children under 5 years of age around the globe
Studies in Asia have evaluated the effectiveness of 3 days of oral amoxicillin for the treatment of fast breathing pneumonia; [2–5] further evidence is needed to determine if 3 days of oral amoxicillin is effective for the treatment of chest indrawing pneumonia
The broad objective of this study is to provide scientific evidence assessing the optimal duration of treatment with amoxicillin dispersible tablets (DT) for chest indrawing childhood pneumonia in a malaria-endemic setting in Malawi, Africa
Summary
Pneumonia is the leading infectious cause of death in children under 5 years of age around the globe. Studies in Asia have evaluated the effectiveness of 3 days of oral amoxicillin for the treatment of fastbreathing pneumonia; further evidence is needed to determine if 3 days of oral amoxicillin is effective for the treatment of chest indrawing pneumonia. There is a need for local studies in malaria-endemic settings in Africa using child-friendly amoxicillin dispersible tablets (DT), which the World Health Organization (WHO) has established as the optimal product formulation for first-line treatment of pneumonia in children less than 5 years of age [5]. The broad objective of this study is to provide scientific evidence assessing the optimal duration of treatment with amoxicillin DT for chest indrawing childhood pneumonia in a malaria-endemic setting in Malawi, Africa. Our alternative hypothesis for this study is that 3 days is non-inferior to 5 days of amoxicillin DT treatment for chest indrawing pneumonia
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