Condition category
Respiratory
Date applied
29/01/2008
Date assigned
20/03/2008
Last edited
21/09/2011
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 Montse Balagué Corbella

ORCID ID

Contact details

Portaferrissa 8
ppal
Barcelona
08002
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI061782

Study information

Scientific title

Rapid antigen detection testing impact on antibiotic use in acute pharyngitis: FARINGOCAT

Acronym

FARINGOCAT

Study hypothesis

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

Study approved by the Research Ethics Committee of the Jordi Gol i Gurina Primary Care Research Insitute (IDIAP), Barcelona on the 4th July 2006.

Study design

Multicentric randomised clinical assay

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

276 patients per group

Participant 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

Recruitment start date

01/01/2008

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Portaferrissa 8, ppal
Barcelona
08002
Spain

Sponsor information

Organisation

Jordi Gol i Gurina Primary Care Research Institute (Institut D'Investigació en Atenció Primària) (IDIAP) (Spain)

Sponsor details

Gran Via de les Corts Catalanes
587 àtic
Barcelona
08007
Spain

Sponsor type

Research organisation

Website

http://www.idiapjgol.org/

Funders

Funder type

Research organisation

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20331895
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21619748

Publication citations

  1. Protocol

    Madurell J, Balagué M, Gómez M, Cots JM, Llor C, Impact of rapid antigen detection testing on antibiotic prescription in acute pharyngitis in adults. FARINGOCAT STUDY: a multicentric randomized controlled trial., BMC Fam Pract, 2010, 11, 25, doi: 10.1186/1471-2296-11-25.

  2. Results

    Llor C, Madurell J, Balagué-Corbella M, Gómez M, Cots JM, Impact on antibiotic prescription of rapid antigen detection testing in acute pharyngitis in adults: a randomised clinical trial., Br J Gen Pract, 2011, 61, 586, e244-51, doi: 10.3399/bjgp11X572436.

Additional files

Editorial Notes