Condition category
Respiratory
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.soton.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes