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:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT00095368
Eligibility Criteria:
Inclusion Criteria:
* Give informed consent, assent and patient authorization
* Age 12 and over
* A clinical diagnosis of acute pharyngitis or tonsillitis
* A positive rapid Strep test
* Can swallow the oral study dosage forms
* Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active
Exclusion Criteria:
* Chronic or recurrent odynophagia
* Need for hospitalization or IV antimicrobial therapy
* Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials
* Known carrier of S. pyogenes
* Allergies to penicillin or other beta-lactam antibiotics
* Any serious illness or concomitant condition that the investigator judges will preclude inclusion to the study
* Seizure disorder
* Pregnant or nursing
* Expectation of additional systemic antibacterials would be required for another condition
* Current drug or alcohol abuse
* Any experimental drug or device within the last 30 days
* Prior systemic antibiotic therapy within the last 30 days
* Hospitalization within the last month which included antibacterial therapy
* The presence of clinically significant hematologic conditions, etc
* Probenecid treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00095368
Study Brief:
Protocol Section:
NCT00095368