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

Phase 3

Completed

• Conditions: Pharyngitis; Tonsillitis

• Registration Number: NCT00095368
• Lead Sponsor: Advancis Pharmaceutical Corporation

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 confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-11-03
• Study First Submitted QC: 2004-11-03
• Study First Posted: 2004-11-04
• Status Verified: 2005-04
• Study Completion: 2005-05
• Last Update Submitted: 2006-12-06
• Last Update Posted: 2006-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bacteriological outcome at the Test of Cure Visit

Secondary Outcome Measures

Name	Time	Method
Bacteriological outcome at the Late Post Therapy Visit
Clinical Outcome
Safety

Trial Locations

Locations (1)

Manford Gooch, MD; 🇺🇸 Salt Lake City, Utah, United States