The FARINGOCAT study: rapid antigen detection testing in acute pharyngitis

ISRCTN	ISRCTN23587778
DOI	https://doi.org/10.1186/ISRCTN23587778
Protocol serial number	PI061782
Sponsor	Jordi Gol i Gurina Primary Care Research Institute (Institut D'Investigació en Atenció Primària) (IDIAP) (Spain)
Funder	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)

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

Portaferrissa 8, ppal
Barcelona
08002
Spain

Study information

Primary study design	Interventional
Study design	Multicentric randomised clinical assay
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	552
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

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	01/05/2011		Yes	No
Protocol article	protocol	23/03/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes