APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
NCT ID: NCT00242281
Last Updated: 2006-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2005-11-30
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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APC-111 MP Tablet, 775 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 antimicrobials
* 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
12 Years
ALL
No
Sponsors
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Advancis Pharmaceutical Corporation
INDUSTRY
Principal Investigators
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Susan P Clausen, PhD
Role: STUDY_DIRECTOR
Advancis Pharmaceutical Corp
Locations
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Birmingham, Alabama, United States
Tallassee, Alabama, United States
Phoenix, Arizona, United States
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
North Wales, Pennsylvania, United States
Scotland, Pennsylvania, United States
Shippensburg, Pennsylvania, United States
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
Coquitlam, British Columbia, Canada
Fort Erie, Ontario, Canada
Markham, Ontario, Canada
Toronto, Ontario, Canada
Saint-Jermone, Quebec, Canada
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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111.302
Identifier Type: -
Identifier Source: org_study_id