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The CHIldren with COugh Randomised Controlled Trial

A clinical effectiveness investigation of a multi-faceted intervention (incorporating a prognostic algorithm) to improve management of antibiotics for CHIldren presenting to primary care with acute COugh and respiratory tract infection (CHICO): an efficient cluster RCT informed by a feasibility RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11405239
Enrollment
310
Registered
2018-04-20
Start date
2018-06-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory tract infections Infections and Infestations Other infectious diseases

Interventions

310 GP practices will take part in the study for 12 months. GP practices will be randomised 1:1 into intervention or usual care. The randomisation will be minimised within each CCG taking part by tota

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The CHICO RCT will recruit GP practices from 15 Clinical Commissioning Groups (CCGs) from demographically diverse regions across England. The population studied will be all children aged 0-9 years registered at practices using the EMISWeb system. The recruitment of practices will be via CCGs using established channels of communication. An internal pilot phase lasting 3 months and using 3 CCGs will help establish best practice for recruiting and communicating with practices before widening to the remaining CCGs over a staggered 4-month recruitment period.

Exclusion criteria

Exclusion criteria: Practices will be asked directly whether they are participating in any antimicrobial stewardship activities during the study period and these will be recorded. If these activities involve concurrent intervention studies where there is potential to confound or modify the effects of our intervention, these practices will be excluded. Children aged 10-14 were considered for inclusion but at this age an increasing number are given antibiotics in tablet form and given the much lower consultation rate in older children the research team decided to exclude this group from the study population.

Design outcomes

Primary

MeasureTime frame
1. The annual rate of dispensed amoxicillin and macrolide prescribed for children (aged 0-9 years registered at the start of the designated period) at each practice over a 12-month period 2. The rate of hospital admission for RTI amongst children aged 0-9 years over a 12-month period

Secondary

MeasureTime frame
1. ED attendance rates for RTI over a 12-month period 2. The costs to the NHS of using the CHICO intervention in a cost-consequence analysis 3. Proportion of locums used in the practice 4. Practice antibiotic dispensing rates in 12 months prior to recruitment 5. Effects of the CHICO intervention on practices with GP prescribers only and those with nurse prescribers as well 6. Effects of the CHICO intervention on different child age groups (5-year epochs) 7. Use of the CHICO intervention by practice and over time in terms of both usage over a 12-month period and seasonality 8. The acceptability and the use of the intervention, how it was embedded into practice and whether it was used, assessed using qualitative interviews with clinicians. The CCG staff interviews will be exploring how well practices embedded the intervention into their systems and daily life from their perspective

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026