APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat

This study has been completed.
Sponsor:
Information provided by:
Advancis Pharmaceutical Corporation
ClinicalTrials.gov Identifier:
NCT00100126
First received: December 23, 2004
Last updated: October 23, 2006
Last verified: April 2005
  Purpose

The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in the bacteriological outcome at the Test of Cure Visit.


Condition Intervention Phase
Pharyngitis
Drug: Amoxicillin Pulsatile Release Multiparticluate Sprinkle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Phase III, Investigator Blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of APC-231 Sprinkle QD for 7 Days vs Penicillin VK 10 mg/kg QID for 10 Days in Pediatric Patients With Streptococcus Pyogenes

Resource links provided by NLM:


Further study details as provided by Advancis Pharmaceutical Corporation:

Primary Outcome Measures:
  • Bacteriological outcome at Test of Cure Visit

Secondary Outcome Measures:
  • Bacteriological outcome at Late Post Therapy Visit
  • Clinical Outcomes
  • Safety

Estimated Enrollment: 500
Study Start Date: December 2004
Estimated Study Completion Date: June 2005
  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Give informed consent, assent, and documentation of patient authorization for disclosure of study results.

Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian.

  • Age > = 6 months -12 years.
  • 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 or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following:

    • Tonsillar or pharyngeal exudate
    • Tender cervical lymph nodes
    • Fever or history of fever treated with antipyretics
    • Odynophagia
    • Uvular edema
    • Pharyngeal Erythema of moderate or greater intensity
    • Elevated white blood cell (WBC) >12,000/mm3 or 10% bands
    • Red tongue and prominent papillae (Strawberry tongue)
  • A positive rapid screening test for S. pyogenes (enzyme immunoassay; SiGNIFY™ Strep A Test).
  • Patient is an appropriate candidate for oral antibiotic therapy and can swallow the study dosage forms.
  • Females must be non-lactating and:

    • If of childbearing potential and sexually active, the patient must have a negative prestudy urine pregnancy test and be utilizing acceptable birth control methods throughout the study.

Exclusion Criteria:

  • Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology.

    • The need for hospitalization or I.V. antimicrobial therapy.
    • Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials.
    • Patients who are known carriers of S. pyogenes.
    • Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials.
    • 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 known immunocompromised state.
  • Hard chills or rigors.

    • Seizure disorder or lowered seizure threshold. This does not exclude children with previous febrile seizures.
    • 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 (or are scheduled to receive any other experimental procedures during the study period).
    • Previous treatment under this protocol.
    • Systemic antimicrobial therapy with benzathine penicillin within 30 days or azithromycin within 14 days.
    • Hospitalization within the month prior to study admission, during which antibacterial therapy was administered.
    • The presence of clinically significant hematologic conditions or cardiac valvular disease.
    • History of cardiovascular disease, renal disease, or neurological disease secondary to previous infection with S. pyogenes.
    • Probenecid treatment or systemic steroids during the duration of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100126

Locations
United States, South Carolina
Simpsonville, South Carolina, United States, 29681
United States, Utah
Institute for Neuroscience Research
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Advancis Pharmaceutical Corporation
Investigators
Study Director: Susan Clausen, PhD Advancis Pharmaceutical Corp
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00100126     History of Changes
Other Study ID Numbers: 231.301
Study First Received: December 23, 2004
Last Updated: October 23, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Advancis Pharmaceutical Corporation:
Pharyngitis
Strep throat

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014