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

NCT00100126 | Completed Phase 3

• 1 other identifier: 231.301
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Pharyngitis

Keywords

Pharyngitis; Strep throat

Outcome Measures

Primary Outcomes (1)

• Bacteriological outcome at Test of Cure Visit

Secondary Outcomes (3)

• Bacteriological outcome at Late Post Therapy Visit

• Clinical Outcomes

• Safety

Interventions

Amoxicillin Pulsatile Release Multiparticluate Sprinkle DRUG

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advancis Pharmaceutical Corporation: lead

Study Sites (2)

Unknown Facility

Simpsonville, South Carolina, 29681, United States

Location

Institute for Neuroscience Research

Salt Lake City, Utah, 84121, United States

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Susan Clausen, PhD

  Advancis Pharmaceutical Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 23, 2004
• First Posted: December 24, 2004
• Study Start: December 1, 2004
• Study Completion: June 1, 2005
• Last Updated: October 25, 2006

Record last verified: 2005-04

Locations

US (2)