Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi

Evangelyn Nkwopara, Robert Schmicker, Tisungane Mvalo, Melda Phiri, Ajib Phiri, Mari Couasnon, Eric McCollum, Amy Sarah Ginsburg

Research output: Contribution to journalArticle

Abstract

Introduction Pneumonia is the leading infectious killer of children. We conducted a double-blind, randomised controlled non-inferiority trial comparing placebo to amoxicillin treatment for fast breathing pneumonia in HIV-negative children aged 2-59 months in Malawi. Occurrence of serious adverse events (SAEs) during the trial were examined to assess disease progression, co-morbidities, recurrence of pneumonia and side effects of amoxicillin. Methods Enrolled children with fast breathing for age and a history of cough <14 days or difficult breathing were randomised to either placebo or amoxicillin for 3 days, and followed for 14 days to track clinical characteristics and outcomes. Medical history, physical exam, laboratory results and any chest radiographs collected at screening, enrolment and during hospitalisation were evaluated. All SAE reports were reviewed for additional information regarding hospitalisation, course of treatment and outcome. Results In total, 102/1126 (9.0%) enrolled children with fast breathing pneumonia were reported to have a SAE. Seventy-five per cent (n=77) of SAEs were pneumonia-related (p<0.01). Children<2 years of age represented the greatest proportion (61/77, 79.2%) of those with a pneumonia-related SAE. In the amoxicillin group, there were 46 SAEs and 5 (10.9%) cases were identified as possibly related to study drug (4 gastroenteritis and 1 fever). There were no life-threatening pneumonia SAEs or deaths in either group, and by the time of exit from the study, all children recovered without sequelae. Discussion In this fast breathing pneumonia clinical trial, SAEs occurred infrequently in both the amoxicillin and placebo groups, and amoxicillin was well tolerated. Trial registration number NCT02760420. https://clinicaltrials.gov/ct2/show/NCT02760420?term=ginsburg&rank=9.

Original languageEnglish (US)
Article numbere00415
JournalBMJ Open Respiratory Research
Volume6
Issue number1
DOIs
StatePublished - Sep 1 2019

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Malawi
Pneumonia
Amoxicillin
Respiration
Clinical Trials
Pediatrics
Placebos
Hospitalization
Gastroenteritis
Cough
Disease Progression
Fever
Thorax
HIV
Morbidity
Recurrence

Keywords

  • pneumonia

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Nkwopara, E., Schmicker, R., Mvalo, T., Phiri, M., Phiri, A., Couasnon, M., ... Ginsburg, A. S. (2019). Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi. BMJ Open Respiratory Research, 6(1), [e00415]. https://doi.org/10.1136/bmjresp-2019-000415

Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi. / Nkwopara, Evangelyn; Schmicker, Robert; Mvalo, Tisungane; Phiri, Melda; Phiri, Ajib; Couasnon, Mari; McCollum, Eric; Ginsburg, Amy Sarah.

In: BMJ Open Respiratory Research, Vol. 6, No. 1, e00415, 01.09.2019.

Research output: Contribution to journalArticle

Nkwopara, Evangelyn ; Schmicker, Robert ; Mvalo, Tisungane ; Phiri, Melda ; Phiri, Ajib ; Couasnon, Mari ; McCollum, Eric ; Ginsburg, Amy Sarah. / Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi. In: BMJ Open Respiratory Research. 2019 ; Vol. 6, No. 1.
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abstract = "Introduction Pneumonia is the leading infectious killer of children. We conducted a double-blind, randomised controlled non-inferiority trial comparing placebo to amoxicillin treatment for fast breathing pneumonia in HIV-negative children aged 2-59 months in Malawi. Occurrence of serious adverse events (SAEs) during the trial were examined to assess disease progression, co-morbidities, recurrence of pneumonia and side effects of amoxicillin. Methods Enrolled children with fast breathing for age and a history of cough <14 days or difficult breathing were randomised to either placebo or amoxicillin for 3 days, and followed for 14 days to track clinical characteristics and outcomes. Medical history, physical exam, laboratory results and any chest radiographs collected at screening, enrolment and during hospitalisation were evaluated. All SAE reports were reviewed for additional information regarding hospitalisation, course of treatment and outcome. Results In total, 102/1126 (9.0{\%}) enrolled children with fast breathing pneumonia were reported to have a SAE. Seventy-five per cent (n=77) of SAEs were pneumonia-related (p<0.01). Children<2 years of age represented the greatest proportion (61/77, 79.2{\%}) of those with a pneumonia-related SAE. In the amoxicillin group, there were 46 SAEs and 5 (10.9{\%}) cases were identified as possibly related to study drug (4 gastroenteritis and 1 fever). There were no life-threatening pneumonia SAEs or deaths in either group, and by the time of exit from the study, all children recovered without sequelae. Discussion In this fast breathing pneumonia clinical trial, SAEs occurred infrequently in both the amoxicillin and placebo groups, and amoxicillin was well tolerated. Trial registration number NCT02760420. https://clinicaltrials.gov/ct2/show/NCT02760420?term=ginsburg&rank=9.",
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AB - Introduction Pneumonia is the leading infectious killer of children. We conducted a double-blind, randomised controlled non-inferiority trial comparing placebo to amoxicillin treatment for fast breathing pneumonia in HIV-negative children aged 2-59 months in Malawi. Occurrence of serious adverse events (SAEs) during the trial were examined to assess disease progression, co-morbidities, recurrence of pneumonia and side effects of amoxicillin. Methods Enrolled children with fast breathing for age and a history of cough <14 days or difficult breathing were randomised to either placebo or amoxicillin for 3 days, and followed for 14 days to track clinical characteristics and outcomes. Medical history, physical exam, laboratory results and any chest radiographs collected at screening, enrolment and during hospitalisation were evaluated. All SAE reports were reviewed for additional information regarding hospitalisation, course of treatment and outcome. Results In total, 102/1126 (9.0%) enrolled children with fast breathing pneumonia were reported to have a SAE. Seventy-five per cent (n=77) of SAEs were pneumonia-related (p<0.01). Children<2 years of age represented the greatest proportion (61/77, 79.2%) of those with a pneumonia-related SAE. In the amoxicillin group, there were 46 SAEs and 5 (10.9%) cases were identified as possibly related to study drug (4 gastroenteritis and 1 fever). There were no life-threatening pneumonia SAEs or deaths in either group, and by the time of exit from the study, all children recovered without sequelae. Discussion In this fast breathing pneumonia clinical trial, SAEs occurred infrequently in both the amoxicillin and placebo groups, and amoxicillin was well tolerated. Trial registration number NCT02760420. https://clinicaltrials.gov/ct2/show/NCT02760420?term=ginsburg&rank=9.

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