Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol

BMC Infectious Diseases
Amy Sarah GinsburgSalim Sadruddin

Abstract

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. 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 stu...Continue Reading

References

Sep 24, 2002·Lancet·UNKNOWN Pakistan Multicentre Amoxycillin Short Course Therapy (MASCOT) pneumonia study group
Apr 1, 2010·International Statistical Review = Revue Internationale De Statistique·Rebecca R Andridge, Roderick J A Little

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Citations

Jul 2, 2020·The New England Journal of Medicine·Amy-Sarah GinsburgSusanne May
Jun 5, 2020·ERJ Open Research·Jennifer L LenahanAmy Sarah Ginsburg
Apr 9, 2019·The European Respiratory Journal·Phuong T K NguyenBen J Marais
Apr 2, 2021·Journal of Global Health·Amy Sarah GinsburgSusanne May

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Methods Mentioned

BETA
blood draw

Clinical Trials Mentioned

NCT02678195

Software Mentioned

Clindex® Clinical Trial Data Management

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