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Repeat assessment of examination signs among children in Malawi with fast-breathing pneumonia.

ABSTRACT: Background:As part of a randomised controlled trial of treatment with placebo versus 3?days of amoxicillin for nonsevere fast-breathing pneumonia among Malawian children aged 2-59?months, a subset of children was hospitalised for observation. We sought to characterise the progression of fast-breathing pneumonia among children undergoing repeat assessments to better understand which children do and do not deteriorate. Methods:Vital signs and physical examination findings, including respiratory rate, arterial oxygen saturation measured by pulse oximetry (S pO2 ), chest indrawing and temperature were assessed every 3?h for the duration of hospitalisation. Children were assessed for treatment failure during study visits on days 1, 2, 3 and 4. Results:Hospital monitoring data from 436 children were included. While no children had S pO2 90-93% at baseline, 7.4% (16 of 215) of children receiving amoxicillin and 9.5% (21 of 221) receiving placebo developed S pO2 90-93% during monitoring. Similarly, no children had chest indrawing at enrolment, but 6.6% (14 of 215) in the amoxicillin group and 7.2% (16 of 221) in the placebo group went on to develop chest indrawing during hospitalisation. Conclusion:Repeat monitoring of children with fast-breathing pneumonia identified vital and physical examination signs not present at baseline, including S pO2 90-93% and chest indrawing. This information may support providers and policymakers in developing guidance for care of children with nonsevere pneumonia.

SUBMITTER: Lenahan JL

PROVIDER: S-EPMC7248340 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Repeat assessment of examination signs among children in Malawi with fast-breathing pneumonia.

Lenahan Jennifer L JL Nkwopara Evangelyn E Phiri Melda M Mvalo Tisungane T Couasnon Mari T MT Turner Kali K Ndamala Chifundo C McCollum Eric D ED May Susanne S Ginsburg Amy Sarah AS

ERJ open research 20200401 2

<h4>Background</h4>As part of a randomised controlled trial of treatment with placebo <i>versus</i> 3 days of amoxicillin for nonsevere fast-breathing pneumonia among Malawian children aged 2-59 months, a subset of children was hospitalised for observation. We sought to characterise the progression of fast-breathing pneumonia among children undergoing repeat assessments to better understand which children do and do not deteriorate.<h4>Methods</h4>Vital signs and physical examination findings, in ...[more]

PMID: 32494572

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Project description:BackgroundDue to increasing antimicrobial resistance in low-resource settings, strategies to rationalize antibiotic treatment of children unlikely to have a bacterial infection are needed. This study's objective was to utilize a database of placebo treated Malawian children with World Health Organization (WHO) fast breathing pneumonia to develop a prognostic risk score that could aid antibiotic decision making.MethodsWe conducted a secondary analysis of children randomized to the placebo group of the Innovative Treatments in Pneumonia (ITIP) fast breathing randomized, controlled, noninferiority trial. Participants were low-risk HIV-uninfected children 2-59 months old with WHO fast breathing pneumonia in Lilongwe, Malawi. Study endpoints were treatment failure, defined as either disease progression at any time on or before Day 4 of treatment or disease persistence on Day 4, or relapse, considered as the recurrence of pneumonia or severe disease among previously cured children between Days 5 and 14. We utilized multivariable linear regression and stepwise model selection to develop a model to predict the probability of treatment failure or relapse.ResultsTreatment failure or relapse occurred in 11.5% (61/526) of children included in this analysis. The final model incorporated the following predictors: heart rate terms, mid-upper arm circumference, malaria status, water source, family income, and whether or not a sibling or other child in the household received childcare outside the home. The model's area under the receiver operating characteristic score was 0.712 (95% confidence interval 0.66, 0.78) and it explained 6.1% of the variability in predicting treatment failure or relapse (R2, 0.061). For the model to categorize all children with treatment failure or relapse correctly, 77% of children without treatment failure or relapse would require antibiotics.ConclusionThe model had inadequate discrimination to be appropriate for clinical application. Different strategies will likely be required for models to perform accurately among similar pediatric populations.

Project description:ImportancePneumonia is the leading infectious killer of children. Rigorous evidence supporting antibiotic treatment of children with nonsevere fast-breathing pneumonia in low-resource African settings is lacking.ObjectiveTo assess whether treatment with placebo for nonsevere fast-breathing pneumonia is substantively less effective than 3 days of treatment with amoxicillin.Design, setting, and participantsThis double-blind, 2-arm, randomized clinical noninferiority trial with follow-up of 14 days screened 1343 HIV-uninfected children aged 2 to 59 months with nonsevere fast-breathing pneumonia at outpatient departments of hospitals in Lilongwe, Malawi, Africa, between June 2016 and June 2017.InterventionsPlacebo or amoxicillin dispersible tablets administered twice daily for 3 days.Main outcomes and measuresThe primary end point was the proportion of children failing treatment by day 4 with a relative noninferiority margin of 1.5 times the failure rate in the amoxicillin group. Primary analyses were performed based on the intention-to-treat principle. Planned secondary analyses included treatment failure or relapse by day 14.ResultsIn total, 1126 children were randomized to 3 days of amoxicillin (n = 564) or placebo (n = 562) therapy. Baseline demographic and clinical characteristics were similar between the groups. For the entire study population, the mean (SD) age was 21.3 (15.1) months, and 601 (53.4%) were female. After an interim analysis, the data safety monitoring board stopped the study because children receiving amoxicillin had a 4.0% (22 of 552 with outcome data) treatment failure rate by day 4, whereas children receiving placebo had a 7.0% (38 of 543) treatment failure rate (adjusted relative risk, 1.78; 95% CI, 1.07%-2.97%; adjusted absolute difference, 3.0%; 95% CI, 0.4%-5.7%). Among children with known day 14 outcomes, 56 of 552 (10.1%) receiving amoxicillin and 64 of 543 (11.8%) receiving placebo had either treatment failure by day 4 or relapse by day 14 (relative risk, 1.16; 95% CI, 0.83%-1.63%; absolute difference, 1.6%; 95% CI, -2.1% to 5.4%). There were no deaths.Conclusions and relevanceIn HIV-uninfected children aged 2 to 59 months in a malaria-endemic region of Malawi, placebo treatment of nonsevere fast-breathing pneumonia was significantly inferior to treatment with amoxicillin. However, by day 4, approximately 93% of children receiving placebo were without treatment failure, and there was no significant difference between groups in treatment failure or relapse by day 14. The number of children with nonsevere fast-breathing pneumonia that needed amoxicillin treatment for 1 child to benefit was 33.Trial registrationClinicalTrials.gov Identifier: NCT02760420.

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Repeat assessment of examination signs among children in Malawi with fast-breathing pneumonia.

Publications

Repeat assessment of examination signs among children in Malawi with fast-breathing pneumonia.

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