Abstract | BACKGROUND:
Pneumonia 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. METHODS: This 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. DISCUSSION: Given 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 REGISTRATION: NCT02678195 : Pre-results. Date registered February 9, 2016.
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Authors | Amy Sarah Ginsburg, Susanne J May, Evangelyn Nkwopara, Gwen Ambler, Eric D McCollum, Tisungane Mvalo, Ajib Phiri, Norman Lufesi, Salim Sadruddin |
Journal | BMC infectious diseases
(BMC Infect Dis)
Vol. 18
Issue 1
Pg. 476
(Sep 21 2018)
ISSN: 1471-2334 [Electronic] England |
PMID | 30241517
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Bacterial Agents
- Tablets
- Amoxicillin
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Topics |
- Administration, Oral
- Amoxicillin
(therapeutic use)
- Anti-Bacterial Agents
(therapeutic use)
- Child, Preschool
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Infant
- Malawi
- Male
- Placebo Effect
- Pneumonia
(drug therapy)
- Tablets
(chemistry)
- Treatment Outcome
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