Evidence map›Paper›PMID 37295836›Full record

ArticleBMJ open2023

Individualised versus standard duration of antibiotic therapy in children with acute uncomplicated febrile urinary tract infection: a study protocol and statistical analysis plan for a multicentre randomised clinical trial.

Naqash Sethi, Emma Louise Malchau Carlsen, Ida Maria Schmidt, Dina Cortes, Ulrikka Nygaard, Line Thousig Sehested

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05301023 (Individualized Antibiotic Therapy Versus Standard Care in Children With Febrile Urinary Tract Infection), 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
1.2field-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.

NCT05301023 phase4completednot on this map

Individualized Antibiotic Therapy Versus Standard Care in Children With Febrile Urinary Tract Infection

TypeinterventionalSponsorRigshospitalet, DenmarkRan2022 to 2024Enrolled408ConditionsFebrile Urinary Tract InfectionArmsIndividualized antibiotic therapy, Standard antibiotic therapy
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

6 authors at 2 institutions in 1 country.

Naqash SethiDepartment of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark naqash.javaid.sethi.02@regionh.dk.ORCID 0000-0002-8025-1939
Emma Louise Malchau CarlsenDepartment of Neonatology, Rigshospitalet, Copenhagen, Denmark.
Ida Maria SchmidtDepartment of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.
Dina CortesDepartment of Pediatrics and Adolescent Medicine, Hvidovre Hospital, Hvidovre, Denmark.
Ulrikka NygaardDepartment of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.
Line Thousig SehestedDepartment of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.
Rigshospitalet · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFebrile urinary tract infection is one of the most common bacterial infections in children. Currently, recommended antibiotic duration is 10 days. However, recent evidence suggests that 90%-95% of children with febrile urinary tract infections are afebrile and clinically improved 48-72 hours after treatment initiation. Accordingly, individualised duration of antibiotic therapy, according to the recovery time, might be more beneficial than current recommendations, but no evidence exists. METHODS AND ANALYSIS: An open-label randomised clinical trial equally randomising children aged 3 months to 12 years from eight Danish paediatric departments with uncomplicated febrile (≥38°C) urinary tract infection to either individualised or standard duration of antibiotic therapy. Children allocated to individualised duration of antibiotic therapy will terminate antibiotic therapy 3 days after clinical improvement with no fever, flank pain or dysuria. Children allocated to standard duration will receive 10 days of antibiotic therapy. Co-primary outcomes are non-inferiority for recurrent urinary tract infection or death within 28 days after the end of treatment (non-inferiority margin 7.5 percentage points) and superiority for the number of days with antibiotic therapy within 28 days after treatment initiation. Seven other outcomes will also be assessed. A total of 408 participants are needed to detect non-inferiority (one-sided alpha 2.5%; beta 80%). ETHICS AND DISSEMINATION: This trial has been approved by the Ethics Committee (H-21057310) and the Data Protection Agency (P-2022-68) in Denmark. Regardless of the trial's findings (whether positive, negative or inconclusive), the results will be compiled into one or more manuscripts for publication in international peer-reviewed scientific journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT05301023.

Indexed as

Bacterial InfectionsUrinary Tract InfectionsAnti-Bacterial AgentsChildChild, PreschoolEquivalence Trials as TopicFeverHumansInfantMulticenter Studies as TopicRandomized Controlled Trials as TopicAnti-Bacterial AgentsClinical trialsPAEDIATRICSUrinary tract infections

Identifiers

PMID37295836
PMCPMC10277096
OpenAlexW4380083069

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.