APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
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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.
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Ages Eligible for Study:
12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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:
Tonsillar or pharyngeal exudates
Tender cervical lymph nodes
Fever or history of fever treated with antipyretics
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
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 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