NCT01125384

Brief Summary

Throat swabbing is an important instrument in the diagnosis of strep pharyngitis and sometimes the main argument for antibiotic treatment. There is no firm knowledge about an appropriate method of the swabbing for receiving maximal sensitivity. We hypothesize that accurate swabbing from the pus will increase the sensitivity of the swabbing as compared to free swabbing. In order to check this hypothesis we will compare two swabs from the same throat. One that will be taken by a physician specifically from the pass and the second will be taken by a nurse as she used to do it. An increase of 10% of positive results will be accepted as a significant advantage.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

1.1 years

First QC Date

May 2, 2010

Last Update Submit

August 27, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • sensitivity of "accurate" swabbing versus sensitivity of habitual nurses' swabbing

    Proportion of positive cultures obtained by "accurate" swabbing will be compared to the proportion of positive cultures obtained by nurses' habitual swabbing (as they do it usually).

    1 year

Study Arms (2)

nurse swabbing

NO INTERVENTION

"accurate" swabbing by a physician

EXPERIMENTAL
Other: additional swabbing

Interventions

physician swabs patient's throat according to standard rules before referral of the patient to throat swabbing by nurse.

"accurate" swabbing by a physician

Eligibility Criteria

Age3 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with sore throat, classified 2-3 according to Cantor's criteria

You may not qualify if:

  • patients on antibiotic treatment
  • suspected carriers of streptococcus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2010

First Posted

May 18, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 30, 2011

Record last verified: 2011-08