JMIR Publications

ABSTRACT

Background:

Pneumonia is the leading infectious cause of death in children under 5 years of age worldwide. Clinical trials are conducted to determine optimal treatment; however, these trials often exclude children with comorbidities and/or severe illness.

Objective:

This is a prospective observational study with the objective to assess clinical outcomes of children aged 2 to 59 months with both pneumonia and other comorbidities in a malaria-endemic region of Malawi.

Methods:

The study enrolls 1,000 children presenting to the outpatient departments of Kamuzu Central or Bwaila District Hospitals in Lilongwe, Malawi with pneumonia who have been excluded from concurrent randomized controlled clinical trials investigating fast breathing and chest indrawing pneumonia, and who meet inclusion criteria for the prospective observational study. Each child receives standard of care for their illnesses per Malawian guidelines and hospital protocol, and is prospectively followed with scheduled study visits at Days 1, 2 (if hospitalized), 6, 14 (in person) and 30 (by phone). We investigate whether the percentages of children cured at Day 14 are lower among those with severe malaria, severe acute malnutrition, or HIV and either fast breathing or chest indrawing than those in the standard of care arms in the concurrent clinical trials. We hypothesize that there is a range of clinical outcomes. This study was approved by the Western Institutional Review Board, Malawi College of Medicine Research and Ethics Committee, and the Malawi Pharmacy, Medicines and Poisons Board. Discussion: Given the paucity of data from Africa, African-based research is necessary to establish optimal management of childhood pneumonia in malaria-endemic settings in the region. An expanded evidence base that includes children with pneumonia and other comorbidities who are at high risk for mortality or have other complications and thus, are typically excluded from childhood pneumonia clinical trials, can contribute to future iterations of World Health Organization Integrated Management of Childhood Illness guidelines. Trial registration NCT02960919: Active, not recruiting. Date registered November 10, 2016.