The FARINGOCAT study: rapid antigen detection testing in acute pharyngitis
| ISRCTN | ISRCTN23587778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23587778 |
| Secondary identifying numbers | PI061782 |
- Submission date
- 29/01/2008
- Registration date
- 20/03/2008
- Last edited
- 21/09/2011
- 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 Montse Balagué Corbella
Scientific
Scientific
Portaferrissa 8, ppal
Barcelona
08002
Spain
Study information
| Study design | Multicentric randomised clinical assay |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Rapid antigen detection testing impact on antibiotic use in acute pharyngitis: FARINGOCAT |
| Study acronym | FARINGOCAT |
| Study objectives | Rapid antigen detection testing would allow a more rational use of antibiotics and would prevent adverse effects of antibiotics on the patient, antibiotic resistance emergence and the growth of inefficient health expense. |
| Ethics approval(s) | Study approved by the Research Ethics Committee of the Jordi Gol i Gurina Primary Care Research Insitute (IDIAP), Barcelona on the 4th July 2006. |
| Health condition(s) or problem(s) studied | Acute pharyngitis |
| Intervention | 1. Rapid antigen detection (case group) 2. Usual antigen detection (control group) Treatment will be decided in both groups by the general practitioner. This treatment could be 'nothing', an anti-thermic drug, anti-inflammatory drug and/or an antibiotic. |
| Intervention type | Other |
| Primary outcome measure | 1. Proportion of inadequate antibiotic prescription in each group 2. Use of antibiotic treatment 3. Use of rapid antigen detection testing 4. Rapid antigen detection testing result 5. Culture result Outcomes will be measured at baseline and three weeks in all patients. If there is a problem, i.e., a secondary effect, then this may take longer. |
| Secondary outcome measures | 1. Clinical symptoms of acute pharyngotonsillitis: fever, tonsillar exudate, cervical adenopathies, absence of cough, measured at baseline and at dates below 2. Age, measured at baseline 3. Antibiotic treatment, measured at baseline and at dates below 4. Specific antibiotic treatment, measured at baseline and at dates below 5. Treatment secondary effects, measured at baseline and at dates below 6. Days without working, measured at baseline and at dates below 7. Medical visits during the first month, measured at week three in all patients, at week four if necessary 8. Patient satisfaction, measured between 3 - 4 weeks after the second visit in one group of patients, between 5 - 7 months in another group of patients Outcomes will be measured at three weeks in all patients. If there is a problem, i.e., a secondary effect, then this may take longer. |
| Overall study start date | 01/01/2008 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 276 patients per group |
| Key inclusion criteria | 1. Men and women 14 to 60 years old 2. More than one acute pharyngitis symptom, i.e., fever, sore throat, tonsillar exudate, cervical adenopathy and absence of cough, which leads to a visit to the family practice |
| Key exclusion criteria | 1. Does not consent to participate 2. Patient is younger than 14 or older than 60 years old 3. Pharyngitis more than five times in year 4. Immunodepression: quimiotherapy, radiotherapy, active neoplasia, acquired immune deficiency syndrome (AIDS), corticoids, immunosuppressor treatment 5. Valve heart disease 6. Rheumatoid fever 7. Pharyngitis with previous treatment during 15 days or recurrence of symptoms during 4 weeks after 7 days of complete antibiotic treatment 8. Pharyngitis of diphtheria or gonococcica cause 9. Tonsillectomy |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Portaferrissa 8, ppal
Barcelona
08002
Spain
08002
Spain
Sponsor information
Jordi Gol i Gurina Primary Care Research Institute (Institut D'Investigació en Atenció Primària) (IDIAP) (Spain)
Research organisation
Research organisation
Gran Via de les Corts Catalanes, 587 àtic
Barcelona
08007
Spain
| Website | http://www.idiapjgol.org/ |
|---|---|
"ROR" |
https://ror.org/0370bpp07 |
Funders
Funder type
Research organisation
Health Research Fund - Carlos III Health Institute of the Spanish Ministry of Health and Consumption (Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-Ministerio de Sanidad y Consumo) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/03/2010 | Yes | No | |
| Results article | results | 01/05/2011 | Yes | No |
