Comparison Between Two Methods of Throat Swabbing
This study has been withdrawn prior to enrollment.
(stopped due to protocol mistakes)
Sponsor:
Meir Medical Center
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01125384
First received: May 2, 2010
Last updated: August 27, 2011
Last verified: August 2011
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Purpose
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 | Intervention |
|---|---|
|
Pharyngitis |
Other: additional swabbing |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Comparison Between Two Methods of Throat Swabbing |
Resource links provided by NLM:
Further study details as provided by Meir Medical Center:
Primary Outcome Measures:
- sensitivity of "accurate" swabbing versus sensitivity of habitual nurses` swabbing [ Time Frame: 1 year ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 3 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01125384 History of Changes |
| Other Study ID Numbers: | MMC10104-09CTIL |
| Study First Received: | May 2, 2010 |
| Last Updated: | August 27, 2011 |
| Health Authority: | Israel: Ethics Commission |
Additional relevant MeSH terms:
|
Pharyngitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013