Comparison Between Two Methods of Throat Swabbing

This study has been withdrawn prior to enrollment.
(stopped due to protocol mistakes)
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014