NCT00535093

Brief Summary

There is a large over-use of antibiotics in family medicine, especially in upper respiratory tract infections. This study is designed to determine if the use of rapid Streptococcal tests in primary care clinics can lower the rate of antibiotic use while not missing bacterial infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 4, 2010

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

September 24, 2007

Last Update Submit

May 2, 2010

Conditions

PharyngitisStreptococcus Pyogenes InfectionStreptococcus Pyogenes Identification

Keywords

PharyngitisCommunity infectionsRapid TestingGroup A Streptococcus

Outcome Measures

Primary Outcomes (1)

  • sensitivity of RST specificity of RST

    3-4 months

Secondary Outcomes (1)

  • ease of use effect on antibacterial prescribing

    3-4 months

Study Arms (1)

1

NO INTERVENTION

All patients fulfilling inclusion criteria will be evaluated for GAS infection using both a rapid streptococcus test and also a standard throat culture

Device: rapid streptococcal testing

Interventions

rapid streptococcal testingDEVICE

Each patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture

1

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • sore throat
  • at least two Centor criteria:
  • fever \> 38 deg C or history of fever
  • enlarged cervical lymph nodes
  • tonsillar exudate
  • lack of cough
  • age 3-14 years

You may not qualify if:

  • antibiotic treatment in preceding 7 days
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services

Jerusalem, Israel

Location

Related Publications (7)

  • Humair JP, Revaz SA, Bovier P, Stalder H. Management of acute pharyngitis in adults: reliability of rapid streptococcal tests and clinical findings. Arch Intern Med. 2006 Mar 27;166(6):640-4. doi: 10.1001/archinte.166.6.640.

    PMID: 16567603BACKGROUND

  • Gieseker KE, Mackenzie T, Roe MH, Todd JK. Comparison of two rapid Streptococcus pyogenes diagnostic tests with a rigorous culture standard. Pediatr Infect Dis J. 2002 Oct;21(10):922-7. doi: 10.1097/00006454-200210000-00007.

    PMID: 12394813BACKGROUND

  • McIsaac WJ, Kellner JD, Aufricht P, Vanjaka A, Low DE. Empirical validation of guidelines for the management of pharyngitis in children and adults. JAMA. 2004 Apr 7;291(13):1587-95. doi: 10.1001/jama.291.13.1587.

    PMID: 15069046BACKGROUND

  • Bisno AL, Gerber MA, Gwaltney JM Jr, Kaplan EL, Schwartz RH; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of group A streptococcal pharyngitis. Infectious Diseases Society of America. Clin Infect Dis. 2002 Jul 15;35(2):113-25. doi: 10.1086/340949. No abstract available.

    PMID: 12087516BACKGROUND

  • Linder JA, Chan JC, Bates DW. Evaluation and treatment of pharyngitis in primary care practice: the difference between guidelines is largely academic. Arch Intern Med. 2006 Jul 10;166(13):1374-9. doi: 10.1001/archinte.166.13.1374.

    PMID: 16832002BACKGROUND

  • Ebell MH, Smith MA, Barry HC, Ives K, Carey M. The rational clinical examination. Does this patient have strep throat? JAMA. 2000 Dec 13;284(22):2912-8. doi: 10.1001/jama.284.22.2912.

    PMID: 11147989BACKGROUND

  • Linder JA, Bates DW, Lee GM, Finkelstein JA. Antibiotic treatment of children with sore throat. JAMA. 2005 Nov 9;294(18):2315-22. doi: 10.1001/jama.294.18.2315.

    PMID: 16278359BACKGROUND

MeSH Terms

Conditions

PharyngitisStreptococcal Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Ian N Miskin, MD

    Clalit Health Services, Jerusalem district

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 4, 2010

Record last verified: 2009-09

Locations

IL(1)