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Safety of Induced Sputum Collection in Children Hospitalized With Severe or Very Severe Pneumonia.

ABSTRACT: Induced sputum (IS) may provide diagnostic information about the etiology of pneumonia. The safety of this procedure across a heterogeneous population with severe pneumonia in low- and middle-income countries has not been described.IS specimens were obtained as part a 7-country study of the etiology of severe and very severe pneumonia in hospitalized children <5 years of age. Rigorous clinical monitoring was done before, during, and after the procedure to record oxygen requirement, oxygen saturation, respiratory rate, consciousness level, and other evidence of clinical deterioration. Criteria for IS contraindications were predefined and serious adverse events (SAEs) were reported to ethics committees and a central safety monitor.A total of 4653 IS procedures were done among 3802 children. Thirteen SAEs were reported in relation to collection of IS, or 0.34% of children with at least 1 IS specimen collected (95% confidence interval, 0.15%-0.53%). A drop in oxygen saturation that required supplemental oxygen was the most common SAE. One child died after feeding was reinitiated 2 hours after undergoing sputum induction; this death was categorized as "possibly related" to the procedure.The overall frequency of SAEs was very low, and the nature of most SAEs was manageable, demonstrating a low-risk safety profile for IS collection even among severely ill children in low-income-country settings. Healthcare providers should monitor oxygen saturation and requirements during and after IS collection, and assess patients prior to reinitiating feeding after the IS procedure, to ensure patient safety.

SUBMITTER: DeLuca AN

PROVIDER: S-EPMC5447836 | biostudies-other | 2017 Jun

REPOSITORIES: biostudies-other

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Safety of Induced Sputum Collection in Children Hospitalized With Severe or Very Severe Pneumonia.

DeLuca Andrea N AN Hammitt Laura L LL Kim Julia J Higdon Melissa M MM Baggett Henry C HC Brooks W Abdullah WA Howie Stephen R C SRC Deloria Knoll Maria M Kotloff Karen L KL Levine Orin S OS Madhi Shabir A SA Murdoch David R DR Scott J Anthony G JAG Thea Donald M DM Amornintapichet Tussanee T Awori Juliet O JO Chuananon Somchai S Driscoll Amanda J AJ Ebruke Bernard E BE Hossain Lokman L Jahan Yasmin Y Kagucia E Wangeci EW Kazungu Sidi S Moore David P DP Mudau Azwifarwi A Mwananyanda Lawrence L Park Daniel E DE Prosperi Christine C Seidenberg Phil P Sylla Mamadou M Tapia Milagritos D MD Zaman Syed M A SMA O'Brien Katherine L KL

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20170601 suppl_3

<h4>Background.</h4>Induced sputum (IS) may provide diagnostic information about the etiology of pneumonia. The safety of this procedure across a heterogeneous population with severe pneumonia in low- and middle-income countries has not been described.<h4>Methods.</h4>IS specimens were obtained as part a 7-country study of the etiology of severe and very severe pneumonia in hospitalized children <5 years of age. Rigorous clinical monitoring was done before, during, and after the procedure to rec ...[more]

PMID: 28575356

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Project description:BackgroundPneumonia is one of the leading causes of morbidity and mortality in under fives. We carried out a comprehensive study to identify factors influencing both mortality and morbidity for children less than 5 years of age hospitalized with severe pneumonia.Methods200 hospitalized children aged 2-60 months with World Health Organization (WHO) defined severe pneumonia were enrolled in the study. The children were managed using a standard protocol. They were closely followed up for need for change in antibiotics, prolonged hospital stay, need for mechanical ventilation and mortality. Data on the factors influencing the outcome were collected.ResultsOf 200 children enrolled in the study, 113 (56.5%) needed a change in antibiotics, 102 (51%) stayed for more than 5 days in the hospital, 41 (20.5%) needed mechanical ventilation and 21 (10.5%) died. On multivariate analysis, lack of exclusive breastfeeding [RR (95%CI) 2.63 (2.16-2.86)], overcrowding [RR (95%CI) 1.94 (1.35-2.38)] and an abnormal chest x-ray [RR (95%CI) 2.29 (1.22-3.44)] were associated with the need for change of antibiotics. Lack of exclusive breastfeeding [RR (95%CI) 2.56 (2.0-2.93)], overcrowding [RR (95%CI) 2.59 (1.78-3.23)] and an abnormal chest x-ray [RR (95%CI) 2.99 (1.65-4.38)] were identified as determinants for prolonged hospital stay. Head nodding [RR (95%CI) 8.34 (2.71-12.77)], altered sensorium [RR (95%CI) 5.44 (1.34-17.56)], abnormal leukocyte counts [RR (95%CI) 5.85(1.36-17.14)] and pallor [RR (95%C) 10.88 (2.95-20.40)] were associated with mortality. Head nodding (RR (95% CI) 4.73 (1.50-6.36)] and cyanosis (RR (95%CI) 5.06 (1.80-11.34)] were the determining factors for mechanical ventilation. In radiographically confirmed pneumonia, the determining factors for change of antibiotics were: lack of exclusive breast feeding [RR (95% CI) 2.05 (1.69-2.2)] and low birth weight [RR (95% CI) 1.59 (1.1-1.89)]. For prolonged hospital stay, the factors identified were mothers' education less than graduation [RR (95% CI) 1.5 (1.19-1.7)], lack of exclusive breast feeding [RR (95% CI) 1.77 (1.19-2.09)] and oxygen saturation of < 90% at time of presentation [RR (95% CI) 2.06 (1.42-2.42)]. Determinants for mechanical ventilation were mothers' education less than graduation [RR (95% CI) 3.6 (1.15-6.3)] and cyanosis at presentation [RR (95% CI) 10.9 (1.56-18.9)]. For mortality, the only determinant was pallor [RR (95% CI) 10.54 (1.8-21.79)].ConclusionChildren hospitalized with severe community acquired pneumonia [as defined by World Health Organization (WHO)] who had not received exclusive breast feeding, had stayed in an overcrowded homes and had an abnormal chest radiograph were more likely to fail to respond with primary antibiotic regimen and require change of antibiotics and prolonged hospital stay. In children with radiographically confirmed pneumonia, lack of breast feeding and low birth weight was associated with need for change in antibiotics.

Project description:Background and objectivesPneumonia is a leading cause of hospitalization and readmission in children. Understanding the patient characteristics associated with pneumonia readmissions is necessary to inform interventions to reduce avoidable hospitalizations and related costs. The objective of this study was to characterize readmission rates, and identify factors and costs associated with readmission among children previously hospitalized with pneumonia.MethodsRetrospective cohort study of children hospitalized with pneumonia at the 43 hospitals included in the Pediatric Health Information System between January 1, 2008, and December 31, 2011. The primary outcome was all-cause readmission within 30 days after hospital discharge, and the secondary outcome was pneumonia-specific readmission. We used multivariable regression models to identify patient and hospital characteristics and costs associated with readmission.ResultsA total of 82?566 children were hospitalized with pneumonia (median age, 3 years; interquartile range 1-7). Thirty-day all-cause and pneumonia-specific readmission rates were 7.7% and 3.1%, respectively. Readmission rates were higher among children <1 year of age, as well as in patients with previous hospitalizations, longer index hospitalizations, and complicated pneumonia. Children with chronic medical conditions were more likely to experience all-cause (odds ratio 3.0; 95% confidence interval 2.8-3.2) and pneumonia-specific readmission (odds ratio 1.8; 95% confidence interval 1.7-2.0) compared with children without chronic medical conditions. The median cost of a readmission ($11?344) was higher than that of an index admission ($4495; P = .01). Readmissions occurred in 8% of pneumonia hospitalizations but accounted for 16.3% of total costs for all pneumonia hospitalizations.ConclusionsReadmissions are common after hospitalization for pneumonia, especially among young children and those with chronic medical conditions, and are associated with substantial costs.

Project description:BackgroundCoronavirus disease 2019 (Covid-19) is associated with immune dysregulation and hyperinflammation, including elevated interleukin-6 levels. The use of tocilizumab, a monoclonal antibody against the interleukin-6 receptor, has resulted in better outcomes in patients with severe Covid-19 pneumonia in case reports and retrospective observational cohort studies. Data are needed from randomized, placebo-controlled trials.MethodsIn this phase 3 trial, we randomly assigned patients who were hospitalized with severe Covid-19 pneumonia in a 2:1 ratio receive a single intravenous infusion of tocilizumab (at a dose of 8 mg per kilogram of body weight) or placebo. Approximately one quarter of the participants received a second dose of tocilizumab or placebo 8 to 24 hours after the first dose. The primary outcome was clinical status at day 28 on an ordinal scale ranging from 1 (discharged or ready for discharge) to 7 (death) in the modified intention-to-treat population, which included all the patients who had received at least one dose of tocilizumab or placebo.ResultsOf the 452 patients who underwent randomization, 438 (294 in the tocilizumab group and 144 in the placebo group) were included in the primary and secondary analyses. The median value for clinical status on the ordinal scale at day 28 was 1.0 (95% confidence interval [CI], 1.0 to 1.0) in the tocilizumab group and 2.0 (non-ICU hospitalization without supplemental oxygen) (95% CI, 1.0 to 4.0) in the placebo group (between-group difference, -1.0; 95% CI, -2.5 to 0; P = 0.31 by the van Elteren test). In the safety population, serious adverse events occurred in 103 of 295 patients (34.9%) in the tocilizumab group and in 55 of 143 patients (38.5%) in the placebo group. Mortality at day 28 was 19.7% in the tocilizumab group and 19.4% in the placebo group (weighted difference, 0.3 percentage points; 95% CI, -7.6 to 8.2; nominal P = 0.94).ConclusionsIn this randomized trial involving hospitalized patients with severe Covid-19 pneumonia, the use of tocilizumab did not result in significantly better clinical status or lower mortality than placebo at 28 days. (Funded by F. Hoffmann-La Roche and the Department of Health and Human Services; COVACTA ClinicalTrials.gov number, NCT04320615.).

Dataset Information

Safety of Induced Sputum Collection in Children Hospitalized With Severe or Very Severe Pneumonia.

Publications

Safety of Induced Sputum Collection in Children Hospitalized With Severe or Very Severe Pneumonia.

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