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

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.

SUBMITTER: Nkwopara E

PROVIDER: S-EPMC6733335 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Nkwopara Evangelyn E Schmicker Robert R Mvalo Tisungane T Phiri Melda M Phiri Ajib A Couasnon Mari M McCollum Eric D ED Ginsburg Amy Sarah AS

BMJ open respiratory research 20190903 1

<h4>Introduction</h4>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.<h4>Methods</h4>Enrolled children with fast bre ...[more]

PMID: 31548894

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Project description:BackgroundSafety data is required to be collected in all clinical trials and can be separated into two types of data, adverse events and serious adverse events. Often, these types of safety data are collected as two discrete data sets, where adverse events that also meet the criteria for seriousness should be reported in both datasets. Safety analyses are often conducted using only the adverse event dataset, which should feature all safety events reported. We investigated whether the reporting of safety in both datasets was systematically followed and explored the impact of this on safety analyses in ICON8, an ovarian cancer clinical trial.MethodsText searches of serious adverse event data identified events that could potentially match the data reported in the adverse event dataset (looking at pre-specified AE terms only). These serious adverse events were then mapped to adverse event data according to predefined criteria: (a) event term matches, (b) date of onset and date of assessment within 30 days of each other, (c) date of assessment lies between date of onset and date of resolution and (d) events confirmed to occur in the same chemotherapy cycle. A combined dataset of all unique safety events (whether originally reported in the adverse event or serious adverse event dataset) was created and safety analyses re-performed.Results51,019 adverse events were reported in ICON8, of which 42,410 were included in the mapping exercise. One thousand five hundred six serious adverse event elements were reported, of which 668 were included in the mapping exercise. Sixty-one percent of serious adverse event elements was matched to an already-reported adverse event. Supplementing these additional safety events and re-performing safety analyses increased the proportion of patients with at least one grade 3 or worse safety events in all arms from 42 to 47% in the control arm and 61 to 65% and 52 to 59% in the research arms. The difference in proportions of grade 3 or worse event in the research arms compared to the control arm changed by 18% (95% confidence interval [CI] 12 to 24%) and 12% (95% CI 6 to 18%), respectively.ConclusionsThere was low agreement in mapping serious adverse events to already reported adverse events, with nearly 40% of serious adverse events included in the mapping exercise not mapped to an already reported adverse event. Any analyses of safety data that use only adverse event datasets or do not clearly account for serious adverse event data will likely be missing important safety information. Reporting standards should make clear which datasets were used for analyses.

Project description:BackgroundLimited data are available on adverse events among children admitted to hospital. The Canadian Paediatric Adverse Events Study was done to describe the epidemiology of adverse events among children in hospital in Canada.MethodsWe performed a 2-stage medical record review at 8 academic pediatric centres and 14 community hospitals in Canada. We reviewed charts from patients admitted from April 2008 through March 2009, evenly distributed across 4 age groups (0 to 28 d; 29 to 365 d; > 1 to 5 yr and > 5 to 18 yr). In stage 1, nurses and health records personnel who had received training in the use of the Canadian Paediatric Trigger Tool reviewed medical records to detect triggers for possible adverse events. In stage 2, physicians reviewed the charts identified as having triggers and described the adverse events.ResultsA total of 3669 children were admitted to hospital during the study period. The weighted rate of adverse events was 9.2%. Adverse events were more frequent in academic pediatric centres than in community hospitals (adjusted odds ratio [OR] 2.98, 95% confidence interval [CI] 1.65-5.39). The incidence of preventable adverse events was not significantly different between types of hospital, but nonpreventable adverse events were more common in academic pediatric centres (adjusted OR 4.39, 95% CI 2.08-9.27). Surgical events predominated overall and occurred more frequently in academic pediatric centres than in community hospitals (37.2% v. 21.5%, relative risk [RR] 1.7, 95% CI 1.0-3.1), whereas events associated with diagnostic errors were significantly less frequent (11.1% v. 23.1%, RR 0.5, 95% CI 0.2-0.9).InterpretationMore children have adverse events in academic pediatric centres than in community hospitals; however, adverse events in the former are less likely to be preventable. There are many opportunities to reduce harm affecting children in hospital in Canada, particularly related to surgery, intensive care and diagnostic error.

Dataset Information

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

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

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