Expired Study
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Salt Lake City, Utah 84121


Purpose:

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).


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


NCT ID:

NCT00095368


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Salt Lake City, Utah 84121
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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