Contact information
Type
Scientific
Primary contact
Dr Paul S Little
ORCID ID
Contact details
Primary Medical Care Group
Community Clinical Sciences Division
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1062
psl3@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G108/322
Study information
Scientific title
Acronym
ACT
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Not Specified
Patient information sheet
Condition
Lower respiratory tract infection
Intervention
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).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/1998
Overall trial end date
30/04/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Patients four years and over presenting with acute cough (less than 21 days) and one or more of: sputum, dyspnoea, wheeze, chest pain
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
1100
Participant exclusion criteria
Main exclusions are pneumonia, chronic lung disease, asthma, other serious pathology
Recruitment start date
01/05/1998
Recruitment end date
30/04/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
University Road
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 5000
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15972565
Publication citations
-
Results
Little P, Rumsby K, Kelly J, Watson L, Moore M, Warner G, Fahey T, Williamson I, Information leaflet and antibiotic prescribing strategies for acute lower respiratory tract infection: a randomized controlled trial., JAMA, 2005, 293, 24, 3029-3035, doi: 10.1001/jama.293.24.3029.