Comparison Between Two Methods of Throat Swabbing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01125384
Recruitment Status : Withdrawn (stopped due to protocol mistakes)
First Posted : May 18, 2010
Last Update Posted : August 30, 2011
Information provided by (Responsible Party):
Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Pharyngitis Other: additional swabbing Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison Between Two Methods of Throat Swabbing
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
No Intervention: nurse swabbing
Experimental: "accurate" swabbing by a physician Other: additional swabbing
physician swabs patient`s throat according to standard rules before referral of the patient to throat swabbing by nurse.

Primary Outcome Measures :
  1. sensitivity of "accurate" swabbing versus sensitivity of habitual nurses` swabbing [ Time Frame: 1 year ]
    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).

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Ages Eligible for Study:   3 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • patients on antibiotic treatment
  • suspected carriers of streptococcus

Responsible Party: Meir Medical Center Identifier: NCT01125384     History of Changes
Other Study ID Numbers: MMC10104-09CTIL
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases