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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00100126
Recruitment Status : Completed
First Posted : December 24, 2004
Last Update Posted : October 25, 2006
Sponsor:
Information provided by:
Advancis Pharmaceutical Corporation

Tracking Information
First Submitted Date  ICMJE December 23, 2004
First Posted Date  ICMJE December 24, 2004
Last Update Posted Date October 25, 2006
Study Start Date  ICMJE December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Bacteriological outcome at Test of Cure Visit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Bacteriological outcome at Late Post Therapy Visit
  • Clinical Outcomes
  • Safety
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Pharyngitis
Intervention  ICMJE Drug: Amoxicillin Pulsatile Release Multiparticluate Sprinkle
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
500
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00100126
Other Study ID Numbers  ICMJE 231.301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Advancis Pharmaceutical Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Susan Clausen, PhD Advancis Pharmaceutical Corp
PRS Account Advancis Pharmaceutical Corporation
Verification Date April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP