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NCT01125384 Clinical Trial

Comparison Between Two Methods of Throat Swabbing

Pharyngitis Clinical Trial

Official title:
Comparison Between Two Methods of Throat Swabbing

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01125384
Other study ID # MMC10104-09CTIL
Secondary ID
Status Withdrawn
Phase N/A
First received May 2, 2010
Last updated August 27, 2011
Start date May 2010
Est. completion date June 2011

Study information
Verified date August 2011
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 500
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 45 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- patients on antibiotic treatment

- suspected carriers of streptococcus

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• additional swabbing
physician swabs patient`s throat according to standard rules before referral of the patient to throat swabbing by nurse.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
See also
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