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 |
| Protocol serial number | G108/322 |
| Sponsor | University of Southampton (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
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 |
|---|---|
| psl3@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | ACT |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Short term: perception of antibiotic efficacy, intention to consult, symptom resolution, fever resolution, complication rate, satisfaction with treatment. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 1100 |
| Key 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 |
| Key exclusion criteria | Main exclusions are pneumonia, chronic lung disease, asthma, other serious pathology |
| Date of first enrolment | 01/05/1998 |
| Date of final enrolment | 30/04/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
