Status:
COMPLETED
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
Lead Sponsor:
Advancis Pharmaceutical Corporation
Conditions:
Pharyngitis
Tonsillitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 confir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00095368
Start Date
October 1 2004
End Date
May 1 2005
Last Update
December 8 2006
Active Locations (1)
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1
Manford Gooch, MD
Salt Lake City, Utah, United States, 84121