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ISRCTN
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ISRCTN92319172
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DOI
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10.1186/ISRCTN92319172
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised controlled trial of a leaflet and three prescribing strategies for the management of acute lower respiratory tract illness. Acute Cough Trial
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Scientific title
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Acronym
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ACT
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Serial number at source
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G108/322
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Study hypothesis
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1. 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
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Lower respiratory tract infection
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Participants - inclusion criteria
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Patients four years and over presenting with acute cough (less than 21 days) and one or more of: sputum, dyspnoea, wheeze, chest pain
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Participants - exclusion criteria
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Main exclusions are pneumonia, chronic lung disease, asthma, other serious pathology
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Anticipated start date
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01/05/1998
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Anticipated end date
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30/04/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1100
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Interventions
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Patients 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).
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Primary outcome measure(s)
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Short 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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15972565
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Contact name
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Dr
Paul S
Little
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Address
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Primary Medical Care Group
Community Clinical Sciences Division
University of Southampton
Aldermoor Health Centre
Aldermoor Close
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City/town
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Southampton
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Zip/Postcode
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SO16 5ST
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Country
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United Kingdom
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Tel
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+44 (0)23 8024 1062
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Fax
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+44 (0)23 8070 1125
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Email
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psl3@soton.ac.uk
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Sponsor
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University of Southampton (UK)
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Address
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University Road
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City/town
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Southampton
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Zip/Postcode
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SO17 1BJ
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Country
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United Kingdom
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Tel
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+44 (0)23 8059 5000
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Fax
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+44 (0)23 8059 3131
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Email
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Sponsor website:
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http://www.soton.ac.uk/
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Date applied
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23/10/2000
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Last edited
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30/07/2009
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Date ISRCTN assigned
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23/10/2000
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