Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT01988558
Eligibility Criteria:
Inclusion Criteria:
* Children at the ages of 5-16.
* Patient is suffering from recurrent documented sore throat with at least 4 tonsillitis episodes during the preceding year (at least one verified by culture or rapid antigen testing for Streptococcus A).
* Patient with clinical presentation of irregular tonsils.
* Tonsils size graded between 2.5-4.
* Clinical diagnosis of bacterial known in recurrent pharyngeal-tonsillitis.
* Patient is willing to participate in the study and adhere to the study protocol
* Patient's guardian and/or Patient have signed informed consent.
Exclusion Criteria:
* Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes (Positive RSAT or microbial culture).
* Subjects who are known as Streptococcus pyogenes carriers
* Subject's requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines), and/or did not completed 14 days from end of antibiotics treatment.
* Subjects with known hypersensitivity to lactose.
* Subject is suffering from peritonsillar abscess.
* Subject suffers from an active peptic ulcer
* Subjects who are suffering from any concomitant disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study results.
* Subject is currently participating in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
16 Years
Study:
NCT01988558
Study Brief:
Protocol Section:
NCT01988558