Randomised controlled trial of a leaflet and three prescribing strategies for the management of acute lower respiratory tract illness. Acute Cough Trial

ISRCTN ISRCTN92319172
DOI https://doi.org/10.1186/ISRCTN92319172
Secondary identifying numbers G108/322
Submission date
23/10/2000
Registration date
23/10/2000
Last edited
30/07/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul S Little
Scientific

Primary Medical Care Group
Community Clinical Sciences Division
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone +44 (0)23 8024 1062
Email psl3@soton.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeNot Specified
Scientific title
Study acronymACT
Study objectives1. To develop, pilot and assess the pragmatic outcomes of three commonly used management strategies for acute lower respiratory tract illness in primary care
2. To determine the effect of an information leaflet
3. To assess predictors of poor outcome
4. To assess predictors of return to surgery
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLower respiratory tract infection
InterventionPatients were assigned to one of six groups by a factorial design: leaflet or no leaflet and one of three antibiotic groups (immediate antibiotics, no offer of antibiotics, and delayed antibiotics).
Intervention typeOther
Primary outcome measureShort term: perception of antibiotic efficacy, intention to consult, symptom resolution, fever resolution, complication rate, satisfaction with treatment.
Long term: return rate to the surgery, admissions, referral.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/1998
Completion date30/04/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants1100
Key inclusion criteriaPatients four years and over presenting with acute cough (less than 21 days) and one or more of: sputum, dyspnoea, wheeze, chest pain
Key exclusion criteriaMain exclusions are pneumonia, chronic lung disease, asthma, other serious pathology
Date of first enrolment01/05/1998
Date of final enrolment30/04/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

University Road
Southampton
SO17 1BJ
England
United Kingdom

Phone +44 (0)23 8059 5000
Website http://www.soton.ac.uk/
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 22/06/2005 Yes No