Malawian children with fast-breathing pneumonia with and without comorbidities (original) (raw)
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Malawian children with chest-indrawing pneumonia with and without comorbidities or danger signs
2021
Background Children with comorbidities or danger signs are often excluded from trials evaluating pneumonia treatment. Methods We sought to investigate whether the percentage of children with chest-indrawing pneumonia cured at Day 14 was lower among those with HIV infection or exposure, malaria, moderate or severe acute malnutrition, or anemia enrolled in a prospective observational cohort study than among children without these comorbidities enrolled in a concurrent prospective randomized controlled trial evaluating duration of amoxicillin treatment in Lilongwe, Malawi. Results Children with chest-indrawing pneumonia and comorbidities but without danger signs did not have statistically significant higher treatment failure rates by Day 6 than those in the chest-indrawing pneumonia clinical trial. However, children with chest-indrawing pneumonia and HIV infection or exposure, malaria, or moderate or severe acute malnutrition had higher rates of not being clinically cured at Day 14 whe...
JMIR Research Protocols
Background Pneumonia is the leading infectious cause of death worldwide among children below 5 years of age. Clinical trials are conducted to determine optimal treatment; however, these trials often exclude children with comorbidities and severe illness. Conclusions Given the paucity of data from Africa, African-based research is necessary to establish optimal management of childhood pneumonia in malaria-endemic settings in the region. An expanded evidence base that includes children with pneumonia and other comorbidities, who are at high risk for mortality or have other complications and are therefore typically excluded from childhood pneumonia clinical trials, can contribute to future iterations of the World Health Organization Integrated Management of Childhood Illness guidelines. Methods The study enrolled 1000 children with pneumonia presenting to the outpatient departments of Kamuzu Central or Bwaila District Hospitals in Lilongwe, Malawi, who were excluded from concurrent ran...
The Lancet Global Health, 2016
Background Few studies have reported long-term data on mortality rates for children admitted to hospital with pneumonia in Africa. We examined trends in case fatality rates for all-cause clinical pneumonia and its risk factors in Malawian children between 2001 and 2012. Methods Individual patient data for children (<5 years) with clinical pneumonia who were admitted to hospitals participating in Malawi's Child Lung Health Programme between 2001 and 2012 were recorded prospectively on a standardised medical form. We analysed trends in pneumonia mortality and children's clinical characteristics, and we estimated the association of risk factors with case fatality for children younger than 2 months, 2-11 months of age, and 12-59 months of age using separate multivariable mixed eff ects logistic regression models. Findings Between November, 2012, and May, 2013, we retrospectively collected all available hard copies of yellow forms from 40 of 41 participating hospitals. We examined 113 154 pneumonia cases, 104 932 (92∧7%) of whom had mortality data and 6903 of whom died, and calculated an overall case fatality rate of 6•6% (95% CI 6•4-6•7). The case fatality rate signifi cantly decreased between 2001 (15•2% [13•4-17•1]) and 2012 (4•5% [4•1-4•9]; p trend <0•0001). Univariable analyses indicated that the decrease in case fatality rate was consistent across most subgroups. In multivariable analyses, the risk factors signifi cantly associated with increased odds of mortality were female sex, young age, very severe pneumonia, clinically suspected Pneumocystis jirovecii infection, moderate or severe underweight, severe acute malnutrition, disease duration of more than 21 days, and referral from a health centre. Increasing year between 2001 and 2012 and increasing age (in months) were associated with reduced odds of mortality. Fast breathing was associated with reduced odds of mortality in children 2-11 months of age. However, case fatality rate in 2012 remained high for children with very severe pneumonia (11•8%), severe undernutrition (15•4%), severe acute malnutrition (34•8%), and symptom duration of more than 21 days (9•0%). Interpretation Pneumonia mortality and its risk factors have steadily improved in the past decade in Malawi; however, mortality remains high in specifi c subgroups. Improvements in hospital care may have reduced case fatality rates though a lack of suffi cient data on quality of care indicators and the potential of socioeconomic and other improvements outside the hospital precludes adequate assessment of why case-fatality rates fell. Results from this study emphasise the importance of eff ective national systems for data collection. Further work combining this with data on trends in the incidence of pneumonia in the community are needed to estimate trends in the overall risk of mortality from pneumonia in children in Malawi. Funding Bill & Melinda Gates Foundation.
JAMA pediatrics, 2018
Pneumonia 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. To assess whether treatment with placebo for nonsevere fast-breathing pneumonia is substantively less effective than 3 days of treatment with amoxicillin. This 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. Placebo or amoxicillin dispersible tablets administered twice daily for 3 days. The 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 ...
Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi
BMJ Open Respiratory Research
IntroductionPneumonia 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.MethodsEnrolled 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.ResultsIn total, 102/1126 (9.0%) enrol...
BMC infectious diseases, 2018
Pneumonia is the leading infectious cause of death in children under 5 years of age around the globe. In addition to preventing pneumonia, there is a critical need to provide greater access to appropriate and effective treatment. Studies in Asia have evaluated the effectiveness of 3 days of oral amoxicillin for the treatment of fast-breathing pneumonia; however, further evidence is needed to determine if 3 days of oral amoxicillin is also effective for the treatment of chest indrawing pneumonia. This is a double-blind, randomized, non-inferiority trial with the objective to assess the effectiveness of shorter duration amoxicillin dispersible tablet (DT) treatment of chest indrawing childhood pneumonia in a malaria-endemic region of Malawi. The primary objective of this study is to determine whether 3 days of treatment with oral amoxicillin DT in HIV-uninfected Malawian children two to 59 months of age with chest indrawing pneumonia is as effective as 5 days of treatment. The study w...
Aetiology and severity of childhood pneumonia in primary care in Malawi: a cohort study
BMJ Open, 2021
ObjectiveTo determine the aetiology of community acquired pneumonia in children presenting to primary care in Northern Malawi, and to ascertain predictors for identification of children requiring hospitalisation.DesignThe BIOmarkers TO diagnose PnEumonia study was a prospective cohort study conducted from March to June 2016.SettingPrimary care in Northern Malawi.Patients494 children aged 2 –59 months with WHO defined pneumonia.Main outcome(s) and measure(s)Number of children with bacterial infection identified and the sensitivity/specificity of WHO markers of severity for need for hospitalisation.Results13 (2.6%) children had a bacterium consistent with pneumonia identified. A virus consistent with pneumonia was identified in in 448 (90.7%) of children. 56 children were admitted to hospital and two children died within 30 days. 442 (89.5%) received antibiotic therapy. Eleven children (2.6%) had HIV. WHO severity markers at baseline demonstrated poor sensitivity for the need for hosp...
PLoS ONE, 2014
Objective: To evaluate the pneumonia specific case fatality rate over time following the implementation of a Child Lung Health Programme (CLHP) within the existing government health services in Malawi to improve delivery of pneumonia case management. Methods: A prospective, nationwide public health intervention was studied to evaluate the impact on pneumonia specific case fatality rate (CFR) in infants and young children (0 to 59 months of age) following the implementation of the CLHP. The implementation was step-wise from October 1 st 2000 until 31 st December 2005 within paediatric inpatient wards in 24 of 25 district hospitals in Malawi. Data analysis compared recorded outcomes in the first three months of the intervention (the control period) to the period after that, looking at trend over time and variation by calendar month, age group, severity of disease and region of the country. The analysis was repeated standardizing the follow-up period by using only the first 15 months after implementation at each district hospital. Findings: Following implementation, 47,228 children were admitted to hospital for severe/very severe pneumonia with an overall CFR of 9N8%. In both analyses, the highest CFR was in the children 2 to 11 months, and those with very severe pneumonia. The majority (64%) of cases, 2-59 months, had severe pneumonia. In this group there was a significant effect of the intervention Odds Ratio (OR) 0N70 (95%CI: 0N50-0N98); p = 0N036), while in the same age group children treated for very severe pneumonia there was no interventional benefit (OR 0N97 (95%CI: 0N72-1N30); p = 0N8). No benefit was observed for neonates (OR 0N83 (95%CI: 0N56-1N22); p = 0N335). Conclusions: The nationwide implementation of the CLHP significantly reduced CFR in Malawian infants and children (2-59 months) treated for severe pneumonia. Reasons for the lack of benefit for neonates, infants and children with very severe pneumonia requires further research.
BMJ Open Respiratory Research
BackgroundPneumonia is the leading infectious killer of children less than 5 years of age worldwide. In addition to vaccines that help prevent pneumonia, understanding the environmental and socioeconomic risk factors for child pneumonia is critical to further prevention.MethodsData from children with fast breathing pneumonia enrolled in a non-inferiority clinical trial assessing the effectiveness of 3-day placebo versus antibiotic treatment in Lilongwe, Malawi were used to examine environmental and socioeconomic characteristics within the study population. Location of residence was collected for enrolled children, and spatial enrolment rates were compared across Lilongwe using a spatial scan statistic.ResultsData from 1101 children were analysed. Three urban subdistricts (locally known as ‘Areas’) (Areas 24, 36 and 38) out of 51 were identified with higher than expected enrolment. These three areas were associated with higher rates of poverty (37.8% vs 23.9%) as well as informal set...