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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advancis Pharmaceutical Corporation
• Treatments: Amoxicillin; Penicillins

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