Back to resultsComparison Between Two Methods of Throat Swabbing
Primary Purpose
Pharyngitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
additional swabbing
Sponsored by
About this trial
This is an interventional diagnostic trial for Pharyngitis
Eligibility Criteria
Inclusion Criteria:
- patients with sore throat, classified 2-3 according to Cantor's criteria
Exclusion Criteria:
- patients on antibiotic treatment
- suspected carriers of streptococcus
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
nurse swabbing
"accurate" swabbing by a physician
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01125384
Brief Title
Comparison Between Two Methods of Throat Swabbing
Official Title
Comparison Between Two Methods of Throat Swabbing
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
stopped due to protocol mistakes
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nurse swabbing
Arm Type
No Intervention
Arm Title
"accurate" swabbing by a physician
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
additional swabbing
Intervention Description
physician swabs patient's throat according to standard rules before referral of the patient to throat swabbing by nurse.
Primary Outcome Measure Information:
Title
sensitivity of "accurate" swabbing versus sensitivity of habitual nurses' swabbing
Description
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).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with sore throat, classified 2-3 according to Cantor's criteria
Exclusion Criteria:
patients on antibiotic treatment
suspected carriers of streptococcus
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Two Methods of Throat Swabbing
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