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Published on: February 24, 2023
Malawian children with fast-breathing pneumonia with and without comorbidities
Amy Sarah Ginsburg1, Tisungane Mvalo2, Jun Hwang3
1University of Washington Clinical Trial Center, Building 29, Suite 250, 6200 NE 74th Street, Seattle, WA, 98115, USA. messageforamy@gmail.com.
Insights
Children with fast-breathing pneumonia and comorbidities, often excluded from trials, showed similar cure rates to those without comorbidities. Early risk assessment and treatment are key for successful outcomes in high-risk pediatric pneumonia cases.
Area of Science:
- Pediatric infectious diseases
- Clinical trial methodology
- Global health
Background:
- Children with comorbidities are often excluded from pneumonia treatment trials due to high mortality risk.
- Understanding outcome heterogeneity in pediatric pneumonia with comorbidities is crucial for effective treatment.
- A concurrent randomized controlled trial (RCT) and observational study were conducted in Malawi.
Purpose of the Study:
- To compare clinical cure rates at Day 14 for children with fast-breathing pneumonia and comorbidities versus those without comorbidities.
- To evaluate if children with comorbidities excluded from an RCT fared worse than those included.
Main Methods:
- A prospective observational study was conducted alongside a randomized controlled trial (RCT) in Lilongwe, Malawi.
- Comorbidities included HIV infection/exposure, malaria, severe acute malnutrition, and anemia.
- Clinical cure at Day 14 was assessed in children with and without comorbidities.
Main Results:
- Among 79 children in the observational cohort, common comorbidities were HIV (72.2%), malaria (25.3%), and anemia (21.5%).
- Treatment failure rates were not significantly different between children with (4.1%) and without (4.5%) comorbidities.
- Clinical cure rates by Day 14 were similar: 95.8% with comorbidities vs. 96.7% without.
Conclusions:
- Children with fast-breathing pneumonia and comorbidities excluded from the RCT did not have worse outcomes.
- Appropriate risk assessment and treatment can lead to clinical cure by Day 14 in high-risk children.
- Early care-seeking by caregivers and timely interventions are vital for pediatric pneumonia management.
Background:
Due 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.
Methods:
We 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.
Results:
Among 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).
Conclusions:
Children 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 Registration:
ClinicalTrials.gov NCT02960919 ; registered November 8, 2016.
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