A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

NCT00643149 | Completed Phase 3

• 1 other identifier: A0661071
• Study Type: interventional
• Target: 693
• Locations: 5 countries
• Sites: 46

Brief Summary

The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.

Conditions

Tonsillitis

Outcome Measures

Primary Outcomes (1)

• Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population

  TOC visit (Day 24-28)

Secondary Outcomes (8)

• Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit

  LTFU Visit (Day 38-45)

• Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population

  TOC Visit (Day 24-28)

• Clinical response (cure or relapse) at the LTFU visit

  LTFU Visit (Day 38-45)

• Pathogen susceptibility versus bacteriologic response

  Not reported

• Adverse events (AEs) were assessed for all treated subjects

  Continuous

Study Arms (2)

1

EXPERIMENTAL

Drug: amoxicillin

2

EXPERIMENTAL

Drug: azithromycin SR

Interventions

amoxicillin DRUG

10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours

1

azithromycin SR DRUG

60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat

2

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.

You may not qualify if:

• Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (46)

Pfizer Investigational Site

Hoover, Alabama, 35244, United States

Location

Pfizer Investigational Site

Pelham, Alabama, 35124, United States

Location

Pfizer Investigational Site

Fresno, California, 93710, United States

Location

Pfizer Investigational Site

Fresno, California, 93720, United States

Location

Pfizer Investigational Site

San Diego, California, 92128, United States

Location

Pfizer Investigational Site

Evansville, Indiana, 47710, United States

Location

Pfizer Investigational Site

Evansville, Indiana, 47713, United States

Location

Pfizer Investigational Site

Evansville, Indiana, 47714, United States

Location

Pfizer Investigational Site

Newburgh, Indiana, 47360, United States

Location

Pfizer Investigational Site

Newburgh, Indiana, 47630, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67207, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67212, United States

Location

Pfizer Investigational Site

Bardstown, Kentucky, 40004, United States

Location

Pfizer Investigational Site

Springfield, Kentucky, 40069, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49009, United States

Location

Pfizer Investigational Site

Endwell, New York, 13760, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27609, United States

Location

Pfizer Investigational Site

Beachwood, Ohio, 44122, United States

Location

Pfizer Investigational Site

Chesterland, Ohio, 44026, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44111, United States

Location

Pfizer Investigational Site

Willoughby, Ohio, 44094, United States

Location

Pfizer Investigational Site

Youngstown, Ohio, 44501, United States

Location

Pfizer Investigational Site

McMurray, Pennsylvania, 15317, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15234, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

Location

Pfizer Investigational Site

Bryan, Texas, 77802, United States

Location

Pfizer Investigational Site

Lake Jackson, Texas, 77566, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84103, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84109, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84111, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84121, United States

Location

Pfizer Investigational Site

West Jordan, Utah, 84088, United States

Location

Pfizer Investigational Site

Calgary, Alberta, T2T 5C7, Canada

Location

Pfizer Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7K 7H9, Canada

Location

Pfizer Investigational Site

Escazú, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

San José, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

Uruca, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

San José, Costa Rica

Location

Pfizer Investigational Site

Guatemala City, Departamento de Guatemala, Guatemala

Location

Pfizer Investigational Site

Hyderabad, Andhara Pradesh, 500 033, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 034, India

Location

Pfizer Investigational Site

Kochi, Kerala, 682 026, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 0124, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Tonsillitis

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 26, 2008
• Study Start: May 1, 2003
• Study Completion: March 1, 2004
• Last Updated: May 17, 2011

Record last verified: 2011-05

Locations

US (33); CA (4); CO (4); IN (4); GU (1)