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
Completed · Phase 3
Conditions studied: Pharyngitis, Tonsillitis
In brief
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).
Key facts
- Study ID
- NCT00095368
- Run by
- Advancis Pharmaceutical Corporation
- People needed
- 500
- Starts
- 2004-10-01
- Expected to finish
- 2005-05-01
- Last updated by the study team
- 2006-12-08
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Manford Gooch, MD — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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