Amy Sarah Ginsburg1, Tisungane Mvalo2, Jun Hwang3, Melda Phiri2, Eric D McCollum4, Madalitso Maliwichi2, Robert Schmicker3, Ajib Phiri5, Norman Lufesi6, Susanne May3. 1. University of Washington Clinical Trial Center, Building 29, Suite 250, 6200 NE 74th Street, Seattle, WA, 98115, USA. messageforamy@gmail.com. 2. University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Lilongwe, Malawi. 3. University of Washington Clinical Trial Center, Building 29, Suite 250, 6200 NE 74th Street, Seattle, WA, 98115, USA. 4. Johns Hopkins School of Medicine, Baltimore, MD, USA. 5. College of Medicine, University of Malawi, Blantyre, Malawi. 6. Malawi Ministry of Health, Lilongwe, Malawi.
Abstract
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.
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.
Authors: Mohammod Jobayer Chisti; Chowdhury Ali Kawser; Abu Sayem Mirza Md Hasibur Rahman; Abu Sadat Mohammad Sayeem Bin Shahid; Farzana Afroze; K M Shahunja; Lubaba Shahrin; Monira Sarmin; Sharika Nuzhat; Ahmed Ehsanur Rahman; Tahmina Alam; Irin Parvin; M S T Mahmuda Ackhter; Gazi Md Salahuddin Mamun; Shamsun Nahar Shaima; Abu Syed Golam Faruque; Tahmeed Ahmed Journal: Sci Rep Date: 2022-06-24 Impact factor: 4.996