APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat

Exclusion Criteria

• •Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology.
• •* The need for hospitalization or I.V. antimicrobial therapy.
• •* Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials.
• •* Patients who are known carriers of S. pyogenes.
• •* Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials.
• •* Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:
• •Any rapidly progressive underlying disease with a shortened life expectancy.
• •The inability to swallow the study dosage form.
• •Unable to understand the requirements of the study.
• •Neutropenia (\<1000 PMNs/mm3) or other known immunocompromised state.
• •Hard chills or rigors.
• •* Seizure disorder or lowered seizure threshold. This does not exclude children with previous febrile seizures.
• •* Psychiatric condition requiring use of major tranquilizers.
• •* Pregnancy or nursing.
• •* Expectation that additional effective systemic antibacterials would be required for any condition during the duration of the study.
• •* Current drug or alcohol abuse.
• •* Receipt of any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the study period).
• •* Previous treatment under this protocol.
• •* Systemic antimicrobial therapy with benzathine penicillin within 30 days or azithromycin within 14 days.
• •* Hospitalization within the month prior to study admission, during which antibacterial therapy was administered.
• •* The presence of clinically significant hematologic conditions or cardiac valvular disease.
• •* History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes.
• •* Probenecid treatment or systemic steroids during the duration of the study.