Clinical trial NCT00242281: APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sore Throat
Pharyngitis
Tonsillitis
Keywords: Sore Throat
Pharyngitis
Tonsillitis
Lead sponsor: Advancis Pharmaceutical Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-20
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 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

Primary outcomes:
measure: The bacteriological outcome at the Test - of - Cure Visit (Day 14-18)
Secondary outcomes:
measure: The bacteriological outcome at the Late Post Therapy visit (Day 38-45)
measure: Clinical Outcome at TOC and LPT
measure: Safety
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tallassee
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Carmichael
country: United States
state: California
city: Laguna Niguel
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Littleton
country: United States
state: Colorado
city: Deland
country: United States
state: Florida
city: Conyers
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Overland Park
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Wichitia
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Milford
country: United States
state: Massachusetts
city: New Bedford
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Johnson City
country: United States
state: New York
city: Burlington
country: United States
state: North Carolina
city: Simpsonville
country: United States
state: North Carolina
city: Canfield
country: United States
state: Ohio
city: North Wales
country: United States
state: Pennsylvania
city: Scotland
country: United States
state: Pennsylvania
city: Shippensburg
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Newport News
country: United States
state: Virginia
city: Edmonds
country: United States
state: Washington
city: Wenatchee
country: United States
state: Washington
city: Coquitlam
country: Canada
state: British Columbia
city: Fort Erie
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Saint-Jermone
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Advancis Pharmaceutical Corp
name: Susan P Clausen, PhD
role: STUDY_DIRECTOR
References: