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This study has been withdrawn prior to enrollment.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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 2, 2010 |
| Last Updated Date | August 27, 2011 |
| Start Date ICMJE | May 2010 |
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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). |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01125384 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Comparison Between Two Methods of Throat Swabbing |
| Official Title ICMJE | Comparison Between Two Methods of Throat Swabbing |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Condition ICMJE | Pharyngitis |
| Intervention ICMJE | Other: additional swabbing
physician swabs patient`s throat according to standard rules before referral of the patient to throat swabbing by nurse. |
| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Withdrawn |
| Estimated Enrollment ICMJE | 500 |
| Completion Date | June 2011 |
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 3 Years to 45 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01125384 |
| Other Study ID Numbers ICMJE | MMC10104-09CTIL |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Meir Medical Center |
| Study Sponsor ICMJE | Meir Medical Center |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Meir Medical Center |
| Verification Date | August 2011 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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