APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Pat… (NCT00095368) | Clinical Trial Compass
CompletedPhase 3
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
United States500 participantsStarted 2004-10
Plain-language summary
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).
Who can participate
Age range12 Years
SexALL
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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