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APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat

Information source: Advancis Pharmaceutical Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sore Throat; Pharyngitis; Tonsillitis

Intervention: APC-111 MP Tablet, 775 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Advancis Pharmaceutical Corporation

Official(s) and/or principal investigator(s):
Susan P Clausen, PhD, Study Director, Affiliation: Advancis Pharmaceutical Corp


The primary objective of this study is to evaluate the efficacy of APC 111 MP Tablet, 775 mg tablet, given orally (PO)once daily (QD) for 10 days compared to that of Penicillin VK, 250 mg PO four times daily (QID) for 10 days in terms of bacteriological outcome at the Test-of-Cure (TOC) Visit (Day 14-18) in the eligible Per-Protocol bacteriological (PPb) population.

Clinical Details

Official title: A Phase III, Multicenter Study to Evaluate the Safety/Efficacy of APC-111 MP Tablet QD vs. Penicillin VK QID Both for 10 Days Treatment of Pharyngitis Secondary to S.Pyogenes in Adolescents/Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)

Secondary outcome:

The bacteriological outcome at the Late Post Therapy visit (Day 38-45)

Clinical Outcome at TOC and LPT



Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Informed consent/assent

- Age 12 and older

- A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the

clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat and pharyngeal erythema with at least one of the following:

- Odynophagia

- Tonsillar or pharyngeal exudates

- Tender cervical lymph nodes

- Fever or history of fever treated with antipyretics

- Chills

- Uvular edema

- Elevated white blood cell count

- Red tongue and prominent papillae

- A positive rapid screening test for S. pyogenes

- Subject is an appropriate candidate for oral antibiotic therapy and can swallow the

study dosage forms

- Females must be non-lactating and:

- At no risk of pregnancy for one of the following reasons: post-menopausal for

at least one year, hysterectomy, tubal ligation, or abstinent from sexual activity that could result in pregnancy, OR

- If of child-bearing potential and sexually active, the patient must have a

negative baseline urine pregnancy test and be utilizing acceptable contraceptives throughout the study.

- If of child bearing potential and not currently sexually active, the patient

must have a negative baseline urine pregnancy test and must agree to remain abstinent for the duration of the study. If they decide to become sexually active during the period of the study, they must agree to use acceptable contraception.

- Are able to comply with the requirements of the protocol

Exclusion Criteria:

- Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology

- More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior

to baseline visit

- Pharyngitis known or suspected to be due to a pathogen resistant to β-lactam


- Subjects who are known carriers of S. pyogenes

- Previous allergies, serious adverse reaction to, or intolerance to penicillin or any

other member of the β-lactam class of antimicrobials, including cephalosporins

- Any serious illness or concomitant condition that the Investigator judges would

preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also include:

- Any rapidly progressive underlying disease with a shortened life expectancy

- The inability to swallow the study dosage form

- Unable to understand the requirements of the study

- Neutropenia (<1000 PMNs/mm3) or other immunocompromised state.

- Concurrent condition of upper/lower respiratory tract infections

- Concurrent symptoms of viral etiology including:

- conjunctivitis, coryza, and cough

- diffuse adenopathy or rash suggestive of mononucleosis

- rash or arthropathy suggestive of scarlet fever

- Seizure disorder, lowered seizure threshold, or psychiatric condition requiring use

of major tranquilizers

- Pregnancy or nursing

- Expectation that additional effective systemic antibacterials would be required for

any condition during the duration of the study

- Current drug or alcohol abuse

- Receipt of any experimental drug or medical device within the previous 30 days

- Previous treatment under this protocol

- The need for hospitalization or I. V. antimicrobial therapy

- Previous systemic antimicrobial therapy within 30 days

- The presence of clinically significant hematologic conditions

- History of cardiovascular disease, renal disease, or neurological disease secondary

to previous infection with S. pyogenes or previous rheumatic fever

- Probenecid treatment or systemic steroids for 7 days prior to baseline visit and

throughout the duration of the study

Locations and Contacts

Birmingham, Alabama, United States

Tallassee, Alabama, United States

Phoenix, Arizona, United States

Coquitlam, British Columbia, Canada

Carmichael, California, United States

Laguna Niguel, California, United States

San Luis Obispo, California, United States

Littleton, Colorado, United States

Deland, Florida, United States

Conyers, Georgia, United States

Boise, Idaho, United States

Overland Park, Kansas, United States

Topeka, Kansas, United States

Wichitia, Kansas, United States

Bardstown, Kentucky, United States

Milford, Massachusetts, United States

New Bedford, Massachusetts, United States

Kalamazoo, Michigan, United States

Butte, Montana, United States

Omaha, Nebraska, United States

Johnson City, New York, United States

Burlington, North Carolina, United States

Simpsonville, North Carolina, United States

Canfield, Ohio, United States

Fort Erie, Ontario, Canada

Markham, Ontario, Canada

Toronto, Ontario, Canada

North Wales, Pennsylvania, United States

Scotland, Pennsylvania, United States

Shippensburg, Pennsylvania, United States

Saint-Jermone, Quebec, Canada

Sherbrooke, Quebec, Canada

Bristol, Tennessee, United States

Kingsport, Tennessee, United States

San Antonio, Texas, United States

Bountiful, Utah, United States

Salt Lake City, Utah, United States

West Jordan, Utah, United States

Newport News, Virginia, United States

Edmonds, Washington, United States

Wenatchee, Washington, United States

Additional Information

Starting date: November 2005
Last updated: October 23, 2006

Page last updated: August 23, 2015

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