Evidence map›Paper›PMID 31123008›Full record

ArticleBMJ open2019

Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia: a protocol for a randomIsed controlled Trial (CAP-IT).

Mark D Lyttle, Julia A Bielicki, Sam Barratt, David Dunn, Adam Finn, Lynda Harper, Pauline Jackson, Colin V E Powell, Damian Roland, Wolfgang Stohr and 9 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 20% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. 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

19 authors at 11 institutions in 4 countries.

Mark D LyttleEmergency Department, Bristol Royal Hospital for Children, Bristol, UK.ORCID 0000-0002-8634-7210
Julia A BielickiPaediatric Infectious Diseases Research Group, MRC Clinical Trial Unit at UCL, Institute for Infection and Immunity, St George's University of London, London, UK.
Sam BarrattMRC Clinical Trials Unit at UCL, London, UK.
David DunnMRC Clinical Trials Unit at UCL, London, UK.
Adam FinnBristol Children's Vaccine Centre, Schools of Population Sciences and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
Lynda HarperMRC Clinical Trials Unit at UCL, London, UK.
Pauline JacksonEmergency Department, Bristol Royal Hospital for Children, Bristol, UK.
Colin V E PowellPaediatric Emergency Medicine Department, Sidra Medicine, Doha, Qatar.
Damian RolandEmergency Department, Paediatric Emergency Medicine Leicester Academic (PEMLA) Group, Leicester, UK.
Wolfgang StohrMRC Clinical Trials Unit at UCL, London, UK.
Kate SturgeonMRC Clinical Trials Unit at UCL, London, UK.
Mandy WanNIHR CRN: Children, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Paul LittleFaculty of Medicine, University of Southampton, Southampton, UK.
Saul N FaustFaculty of Medicine, University of Southampton, Southampton, UK.
Julie RobothamHCAI and AMR Division, National Infection Service, Public Health England, London, UK.
Alastair D HayCentre for Academic Primary Care, University of Bristol, Bristol, UK.
Diana M GibbMRC Clinical Trials Unit at UCL, London, UK.
Mike SharlandPaediatric Infectious Diseases Research Group, MRC Clinical Trial Unit at UCL, Institute for Infection and Immunity, St George's University of London, London, UK.
PERUKI, GAPRUKI and the CAP-IT trial team
MRC Clinical Trials Unit at UCL · GBSt George's, University of London · GBUniversity of Bristol · GBBristol Royal Hospital for Children · GBFaculty (United Kingdom) · GBGuy's and St Thomas' NHS Foundation Trust · GBPublic Health England · GBSidra Medical and Research Center · QAUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of Leicester · GBUniversity of the West of England · GB

Funding

Department of Health HTA/13/88/11Medical Research Council MC_U122886353Medical Research Council MC_UU_12023/17Medical Research Council MC_UU_12023/22Medical Research Council MC_UU_12023/26
6 · The paper itself

Abstract

introductionCommunity-acquired pneumonia (CAP) is a common indication for antibiotic treatment in young children. Data are limited regarding the ideal dose and duration of amoxicillin, leading to practice variation which may impact on treatment failure and antimicrobial resistance (AMR). Community-Acquired Pneumonia: a randomIsed controlled Trial (CAP-IT) aims to determine the optimal amoxicillin treatment strategies for CAP in young children in relation to efficacy and AMR. METHODS AND ANALYSIS: The CAP-IT trial is a multicentre, randomised, double-blind, placebo-controlled 2×2 factorial non-inferiority trial of amoxicillin dose and duration. Children are enrolled in paediatric emergency and inpatient environments, and randomised to receive amoxicillin 70-90 or 35-50 mg/kg/day for 3 or 7 days following hospital discharge. The primary outcome is systemic antibacterial treatment for respiratory tract infection (including CAP) other than trial medication up to 4 weeks after randomisation. Secondary outcomes include adverse events, severity and duration of parent-reported CAP symptoms, adherence and antibiotic resistance. The primary analysis will be by intention to treat. Assuming a 15% primary outcome event rate, 8% non-inferiority margin assessed against an upper one-sided 95% CI, 90% power and 15% loss to follow-up, 800 children will be enrolled to demonstrate non-inferiority for the primary outcome for each of duration and dose. ETHICS AND DISSEMINATION: The CAP-IT trial and relevant materials were approved by the National Research Ethics Service (reference: 16/LO/0831; 30 June 2016). The CAP-IT trial results will be published in peer-reviewed journals, and in a report published by the National Institute for Health Research Health Technology Assessment programme. Oral and poster presentations will be given to national and international conferences, and participating families will be notified of the results if they so wish. Key messages will be constructed in partnership with families, and social media will be used in their dissemination. TRIAL REGISTRATION NUMBER: ISRCTN76888927, EudraCT2016-000809-36.

Indexed as

AmoxicillinAnti-Bacterial AgentsCommunity-Acquired InfectionsPenicillin ResistancePneumoniaChildChild, PreschoolDose-Response Relationship, DrugDouble-Blind MethodDuration of TherapyEquivalence Trials as TopicHumansInfantMulticenter Studies as TopicRetreatmentAmoxicillinAnti-Bacterial Agentsantimicrobial resistancecommunity-acquired pneumonia

Identifiers

PMID31123008
PMCPMC6538022
OpenAlexW2945127136

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.