APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat
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The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).
A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 Days vs Penicillin VK 250 mg QID for 10 Days in Patients With Streptococcus Pyogenes
Study Start Date :
Study Completion Date :
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Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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