A randomized controlled trial of hospital versus home based therapy with oral amoxicillin for severe pneumonia in children aged 3 – 59 months: The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study

Patel, Archana; Bang, Akash; Singh, Meenu; Dhande, Leena; Chelliah, Luke Ravi; Malik, Ajamaluddin; Khadse, Sandhya

doi:10.1186/s12887-015-0510-9

Cited by 21 publications

(31 citation statements)

References 13 publications

(12 reference statements)

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“…In the IndiaCLEN multi-centre trial (NCT01386840), the safety and efficacy of oral amoxicillin for severe pneumonia at home or in hospital were compared [ 28 ]. This open-label, multi-centre, prospective, two-arm, randomised clinical trial in children aged 3–59 months with severe pneumonia aimed to determine the differences in treatment failure between a 7-day course of oral amoxicillin for the first 48 h in hospital and being sent home on the same treatment after enrolment.…”

Section: Resultsmentioning

confidence: 99%

Antibiotic use for community-acquired pneumonia in neonates and children: WHO evidence review

Mathur

Fuchs

Bielicki

et al. 2018

Paediatrics and International Child Health

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Background Pneumonia is the most common cause of death in children worldwide, accounting for 15% of all deaths of children under 5 years of age. This review summarises the evidence for the empirical antibiotic treatment of community-acquired pneumonia in neonates and children and puts emphasis on publications since the release of the previous WHO Evidence Summary report published in 2014. Methods A systematic search for systematic reviews and meta-analyses of antibiotic therapy for community-acquired pneumonia was conducted between 1 January 2013 and 10 November 2016. Results The optimal dosing recommendation for amoxicillin remains unclear with limited pharmacological and clinical evidence. There is limited evidence from surveillance to indicate whether amoxicillin or broader spectrum antibiotics (e.g. third-generation cephalosporins) are being used most commonly for paediatric CAP in different WHO regions. Data are lacking on clinical efficacy in the context of pneumococcal, staphylococcal and mycoplasma disease and the relative contributions of varying first-line and step-down options to the selection of such resistance. Conclusion Further pragmatic trials are required to optimise management of hospitalised children with severe and very severe pneumonia.

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Section: Resultsmentioning

confidence: 99%

Antibiotic use for community-acquired pneumonia in neonates and children: WHO evidence review

Mathur

Fuchs

Bielicki

et al. 2018

Paediatrics and International Child Health

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“…This criteria was removed as a referral sign in the revised 2014 WHO IMCI chart booklet [ 8 ] following controlled low-mortality trials that indicated chest indrawing episodes could be managed at home without increased risk [ 25 , 26 ], and Malawi made this change too in 2018. Since then, 3 other randomised trials—one each in India, Kenya, and Malawi—have demonstrated that chest indrawing pneumonia can be treated with oral amoxicillin on an outpatient basis [ 27 – 29 ]. However, for CHWs, chest indrawing remains a referral sign.…”

Section: Discussionmentioning

confidence: 99%

Predictive value of pulse oximetry for mortality in infants and children presenting to primary care with clinical pneumonia in rural Malawi: A data linkage study

et al. 2020

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Background The mortality impact of pulse oximetry use during infant and childhood pneumonia management at the primary healthcare level in low-income countries is unknown. We sought to determine mortality outcomes of infants and children diagnosed and referred using clinical guidelines with or without pulse oximetry in Malawi. Methods and findings We conducted a data linkage study of prospective health facility and community case and mortality data. We matched prospectively collected community health worker (CHW) and health centre (HC) outpatient data to prospectively collected hospital and community-based mortality surveillance outcome data, including episodes followed up to and deaths within 30 days of pneumonia diagnosis amongst children 0–59 months old. All data were collected in Lilongwe and Mchinji districts, Malawi, from January 2012 to June 2014. We determined differences in mortality rates using <90% and <93% oxygen saturation (SpO 2 ) thresholds and World Health Organization (WHO) and Malawi clinical guidelines for referral. We used unadjusted and adjusted (for age, sex, respiratory rate, and, in analyses of HC data only, Weight for Age Z-score [WAZ]) regression to account for interaction between SpO 2 threshold (pulse oximetry) and clinical guidelines, clustering by child, and CHW or HC catchment area. We matched CHW and HC outpatient data to hospital inpatient records to explore roles of pulse oximetry and clinical guidelines on hospital attendance after referral. From 7,358 CHW and 6,546 HC pneumonia episodes, we linked 417 CHW and 695 HC pneumonia episodes to 30-day mortality outcomes: 16 (3.8%) CHW and 13 (1.9%) HC patients died. SpO 2 thresholds of <90% and <93% identified 1 (6%) of the 16 CHW deaths that were unidentified by integrated community case management (iCCM) WHO referral protocol and 3 (23%) and 4 (31%) of the 13 HC deaths, respectively, that were unidentified by the integrated management of childhood illness (IMCI) WHO protocol. Malawi IMCI referral protocol, which differs from WHO protocol at the HC level and includes chest indrawing, identified all but one of these deaths. SpO 2 < 90% predicted death independently of WHO danger signs compared with SpO 2 ≥ 90%: HC Risk Ratio (RR), 9.37 (95% CI: 2.17–40.4, p = 0.003); CHW RR, 6.85 (1.15–40.9, p = 0.035). SpO 2 < 93% was also predictive versus SpO 2 ≥ 93% at HC level: RR, 6.68 (1.52–29.4, p = 0.012). Hospital referrals and outpatient episodes with referral decision indications were associated with mortality. A substantial proportion of those referred were not found admitted in the inpatients within 7 days of referral advice. All 12 deaths in 73 hospitalised children occurred within 24 hours of arrival in the hospital, which highlights delay in appropriate care seeking. The main limitation of our study wa...

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“…Previous antibiotic treatment and household air pollution reduction trials have failed to show an association between pneumonia and the exposure of interest. 10,11,[104][105][106][107][108][109] Many of these trials used the WHO definition of pneumonia, which is solely based on clinical symptoms and signs, is highly sensitive, but also has a low specificity. Although effective in informing treatment guidelines that largely reduced childhood mortality, 21,32 use of the WHO definition could lead to reduced effect size and study power in field trials.…”

Section: Discussionmentioning

confidence: 99%

Challenges in the diagnosis of paediatric pneumonia in intervention field trials: recommendations from a pneumonia field trial working group

Goodman¹,

Pervaiz²,

McCollum³

et al. 2019

The Lancet Respiratory Medicine

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Pneumonia is a leading killer of children younger than 5 years despite high vaccination coverage, improved nutrition, and widespread implementation of the Integrated Management of Childhood Illnesses algorithm. Assessing the effect of interventions on childhood pneumonia is challenging because the choice of case definition and surveillance approach can affect the identification of pneumonia substantially. In anticipation of an intervention trial aimed to reduce childhood pneumonia by lowering household air pollution, we created a working group to provide recommendations regarding study design and implementation. We suggest to, first, select a standard case definition that combines acute (≤14 days) respiratory symptoms and signs and general danger signs with ancillary tests (such as chest imaging and pulse oximetry) to improve pneumonia identification; second, to prioritise active hospital-based pneumonia surveillance over passive case finding or home-based surveillance to reduce the risk of non-differential misclassification of pneumonia and, as a result, a reduced effect size in a randomised trial; and, lastly, to consider longitudinal follow-up of children younger than 1 year, as this age group has the highest incidence of severe pneumonia.

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A randomized controlled trial of hospital versus home based therapy with oral amoxicillin for severe pneumonia in children aged 3 – 59 months: The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study

Cited by 21 publications

References 13 publications

Antibiotic use for community-acquired pneumonia in neonates and children: WHO evidence review

Antibiotic use for community-acquired pneumonia in neonates and children: WHO evidence review

Predictive value of pulse oximetry for mortality in infants and children presenting to primary care with clinical pneumonia in rural Malawi: A data linkage study

Challenges in the diagnosis of paediatric pneumonia in intervention field trials: recommendations from a pneumonia field trial working group

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