The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in
the bacteriological outcome at the Test of Cure Visit.
Minimum age: 6 Months.
Maximum age: 12 Years.
Give informed consent, assent, and documentation of patient authorization for disclosure
of study results.
Since all patients are below the legal age of consent, assent from the patient must be
obtained (as applicable following state regulations) and written informed consent obtained
from the parent or legal guardian.
- Age > = 6 months -12 years.
- A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the
clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including
sore throat or difficulty feeding or swallowing or irritability that suggests the
presence of a sore throat with at least one of the following:
- Tonsillar or pharyngeal exudate
- Tender cervical lymph nodes
- Fever or history of fever treated with antipyretics
- Uvular edema
- Pharyngeal Erythema of moderate or greater intensity
- Elevated white blood cell (WBC) >12,000/mm3 or 10% bands
- Red tongue and prominent papillae (Strawberry tongue)
- A positive rapid screening test for S. pyogenes (enzyme immunoassay; SiGNIFY™ Strep A
- Patient is an appropriate candidate for oral antibiotic therapy and can swallow the
study dosage forms.
- Females must be non-lactating and:
- If of childbearing potential and sexually active, the patient must have a
negative prestudy urine pregnancy test and be utilizing acceptable birth control
methods throughout the study.
- 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
- 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
- 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
- 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.