Abstract
BackgroundDue to high risk of mortality, children with comorbidities are typically excluded from trials evaluating pneumonia treatment. Understanding heterogeneity of outcomes among children with pneumonia and comorbidities is critical to ensuring appropriate treatment.MethodsWe explored whether the percentage of children with fast-breathing pneumonia cured at Day 14 was lower among those with selected comorbidities enrolled in a prospective observational study than among those enrolled in a concurrent randomized controlled trial evaluating treatment with amoxicillin in Lilongwe, Malawi.ResultsAmong 79 children with fast-breathing pneumonia in the prospective observational cohort, 57 (72.2%) had HIV infection/exposure, 20 (25.3%) had malaria, 2 (2.5%) had severe acute malnutrition, and 17 (21.5%) had anemia. Treatment failure rate was slightly (not significantly) lower in children with comorbidities (4.1%, 3/73) compared to those without comorbidities (4.5%, 25/552) similarly treated. There was no significant difference in clinical cure rates by Day 14 (95.8% with vs 96.7% without comorbidity).ConclusionsChildren with fast-breathing pneumonia excluded from a concurrent clinical trial due to comorbidities did not fare worse. Children at higher risk whose caregivers seek care early and who receive appropriate risk assessment (e.g., pulse oximetry, hemoglobin, HIV/malaria testing) and treatment, can achieve clinical cure by Day 14.Trial registrationClinicalTrials.govNCT02960919; registered November 8, 2016.
Highlights
Due to high risk of mortality, children with comorbidities are typically excluded from trials evaluating pneumonia treatment
Of the 79 ITIP3 fastbreathing pneumonia (FBP) children enrolled, 72.2% (57/79) were HIV-infected or exposed, 25.3% (20/79) had malaria, 2.5% (2/79) met severe acute malnutrition criteria either by mid-upper arm circumference < 115 mm or weight-for-height z-score < − 3, and 21.5% (17/79) had anemia defined as a hemoglobin < 8.0 g/dL (Fig. 1)
When comparing ITIP3’s FBP cohort to all children enrolled in ITIP1’s FBP clinical trial, there were a few differences in baseline characteristics (Table 2)
Summary
Due to high risk of mortality, children with comorbidities are typically excluded from trials evaluating pneumonia treatment. Clinical trials evaluating treatment for pneumonia may exclude children with comorbidities who are at high risk for mortality or have other complications. Cough less than 14 days or difficulty breathing AND fast breathing for age. Cough less than 14 days or difficulty breathing AND visible indrawing of the chest wall with or without fast breathing for age. Fast breathing for age Respiratory rate ≥ 50 breaths per minute (for children 2 to < 12 months of age) or ≥ 40 breaths per minute (for children ≥12 months of age). ≥70 breaths per minute (for children 2 to < 12 months of age) or ≥ 60 breaths per minute (for children ≥12 months of age).
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