Evidence map›Paper›PMID 29391051›Full record

ArticleTrials2018

Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial.

Jeffrey Pernica, Stuart Harman, April Kam, Jacob Bailey, Redjana Carciumaru, Sarah Khan, Martha Fulford, Lehana Thabane, Robert Slinger, Cheryl Main and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02380352 (Short-course Antimicrobial Therapy for Paediatric Respiratory Infections), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02380352 phase4completednot on this map

Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

TypeinterventionalSponsorHamilton Health Sciences CorporationRan2016 to 2020Enrolled281ConditionsCommunity-acquired PneumoniaArmsAmoxicillin, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Jeffrey PernicaDivision of Infectious Disease, Department of Pediatrics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. pernica@mcmaster.ca.
Stuart HarmanDivision of Emergency Medicine, Department of Pediatrics, University of Ottawa, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
April KamDivision of Emergency Medicine, Department of Pediatrics, McMaster University, Hamilton, ON, Canada.
Jacob BaileyFaculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Redjana CarciumaruDepartment of Pediatrics, McMaster University, Hamilton, ON, Canada.
Sarah KhanDivision of Infectious Disease, Department of Pediatrics, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Martha FulfordDivision of Infectious Disease, Department of Medicine, McMaster University, Hamilton, ON, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, Hamilton, ON, Canada.
Robert SlingerDepartment of Pathology and Laboratory Medicine, University of Ottawa, Ottawa, ON, Canada.
Cheryl MainDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
Marek SmiejaDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
Mark LoebDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
McMaster University · CAUniversity of Ottawa · CAImpact · CA

Funding

Hamilton Health Sciences Early Career AwardPhysicians' Services Incorporated Foundation #14-34
6 · The paper itself

Abstract

backgroundCommunity-acquired pneumonia (CAP) is commonly diagnosed in children. The Infectious Disease Society of America guidelines recommend 10 days of high-dose amoxicillin for the treatment of non-severe CAP but 5-day "short course" therapy may be just as effective. Randomized trials in adults have already demonstrated non-inferiority of 5-day short-course treatment for adults hospitalized with severe CAP and for adults with mild CAP treated as outpatients. Minimizing exposure to antimicrobials is desirable to avoid harms including diarrhoea, rashes, severe allergic reactions, increased circulating antimicrobial resistance, and microbiome disruption.

methodsThe objective of this multicentre, randomized, non-inferiority, controlled trial is to investigate whether 5 days of high-dose amoxicillin is associated with lower rates of clinical cure 14-21 days later as compared to 10 days of high-dose amoxicillin, the reference standard. Recruitment and enrolment will occur in the emergency departments of McMaster Children's Hospital and the Children's Hospital of Eastern Ontario. All children in the study will receive 5 days of amoxicillin after which point they will receive either 5 days of a different formulation of amoxicillin or a placebo. Assuming a clinical failure rate of 5% in the reference arm, a non-inferiority margin of 7.5%, one-sided alpha set at 0.025 and power of 0.80, 270 participants will be required. Participants from a previous feasibility study (n = 60) will be rolled over into the current study. We will be performing multiplex respiratory virus molecular testing, quantification of nasopharyngeal pneumococcal genomic loads, salivary inflammatory marker testing, and faecal microbiome profiling on participants. DISCUSSION: This is a pragmatic study seeking to provide high-quality evidence for front-line physicians evaluating children presenting with mild CAP in North American emergency departments in the post-13-valent pneumococcal, conjugate vaccine era. High-quality evidence supporting the non-inferiority of short-course therapy for non-severe paediatric CAP should be generated prior to making changes to established guidelines.

trial registrationClinicalTrials.gov, NCT02380352 . Registered on 2 March 2015.

Indexed as

Age FactorsAmoxicillinAnti-Infective AgentsAntimicrobial StewardshipChildChild, PreschoolCommunity-Acquired InfectionsDouble-Blind MethodDrug Administration ScheduleEquivalence Trials as TopicFemaleHumansMaleMulticenter Studies as TopicOntarioPragmatic Clinical Trials as TopicAmoxicillinAnti-Infective AgentsAmoxicillinAntimicrobial stewardshipCommunity-acquired pneumoniaMicrobiomeRespiratory virusStreptococcus pneumoniae

Identifiers

PMID29391051
PMCPMC5796490
OpenAlexW2786186356

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.