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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00643149

Collaborator

(none)

693

Enrollment

Locations

Arms

Duration (Months)

15.4

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tonsillitis	Drug: amoxicillin Drug: azithromycin SR	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

693 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A Β-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children

Study Start Date :

May 1, 2003

Actual Study Completion Date :

Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: amoxicillin 10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
Experimental: 2	Drug: azithromycin SR 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

Arm

Intervention/Treatment

Experimental: 1

Drug: amoxicillin

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

Experimental: 2

Drug: azithromycin SR

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

Outcome Measures

Primary Outcome Measures

Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population [TOC visit (Day 24-28)]

Secondary Outcome Measures

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]
Vital signs and physical examinations were recorded [Baseline and as necessary]
Clinical laboratory testing (hematology and blood chemistry) [As necessary]
Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Hoover	Alabama	United States	35244
2	Pfizer Investigational Site	Pelham	Alabama	United States	35124
3	Pfizer Investigational Site	Fresno	California	United States	93710
4	Pfizer Investigational Site	Fresno	California	United States	93720
5	Pfizer Investigational Site	San Diego	California	United States	92128
6	Pfizer Investigational Site	Evansville	Indiana	United States	47710
7	Pfizer Investigational Site	Evansville	Indiana	United States	47713
8	Pfizer Investigational Site	Evansville	Indiana	United States	47714
9	Pfizer Investigational Site	Newburgh	Indiana	United States	47360
10	Pfizer Investigational Site	Newburgh	Indiana	United States	47630
11	Pfizer Investigational Site	Wichita	Kansas	United States	67207
12	Pfizer Investigational Site	Wichita	Kansas	United States	67212
13	Pfizer Investigational Site	Bardstown	Kentucky	United States	40004
14	Pfizer Investigational Site	Springfield	Kentucky	United States	40069
15	Pfizer Investigational Site	Kalamazoo	Michigan	United States	49009
16	Pfizer Investigational Site	Endwell	New York	United States	13760
17	Pfizer Investigational Site	Raleigh	North Carolina	United States	27609
18	Pfizer Investigational Site	Beachwood	Ohio	United States	44122
19	Pfizer Investigational Site	Chesterland	Ohio	United States	44026
20	Pfizer Investigational Site	Cleveland	Ohio	United States	44106
21	Pfizer Investigational Site	Cleveland	Ohio	United States	44111
22	Pfizer Investigational Site	Willoughby	Ohio	United States	44094
23	Pfizer Investigational Site	Youngstown	Ohio	United States	44501
24	Pfizer Investigational Site	McMurray	Pennsylvania	United States	15317
25	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15234
26	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15241
27	Pfizer Investigational Site	Bryan	Texas	United States	77802
28	Pfizer Investigational Site	Lake Jackson	Texas	United States	77566
29	Pfizer Investigational Site	Salt Lake City	Utah	United States	84103
30	Pfizer Investigational Site	Salt Lake City	Utah	United States	84109
31	Pfizer Investigational Site	Salt Lake City	Utah	United States	84111
32	Pfizer Investigational Site	Salt Lake City	Utah	United States	84121
33	Pfizer Investigational Site	West Jordan	Utah	United States	84088
34	Pfizer Investigational Site	Calgary	Alberta	Canada	T2T 5C7
35	Pfizer Investigational Site	Coquitlam	British Columbia	Canada	V3K 3P4
36	Pfizer Investigational Site	Winnipeg	Manitoba	Canada	R3A 1M3
37	Pfizer Investigational Site	Saskatoon	Saskatchewan	Canada	S7K 7H9
38	Pfizer Investigational Site	Escazu	San Jose	Costa Rica
39	Pfizer Investigational Site	La Uruca	San Jose	Costa Rica
40	Pfizer Investigational Site	San Jose		Costa Rica
41	Pfizer Investigational Site	Guatemala		Guatemala
42	Pfizer Investigational Site	Hyderabad	Andhara Pradesh	India	500 033
43	Pfizer Investigational Site	Bangalore	Karnataka	India	560 034
44	Pfizer Investigational Site	Kochi	Kerala	India	682 026
45	Pfizer Investigational Site	Mumbai	Maharashtra	India	400 0124

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00643149

Other Study ID Numbers:

A0661071

First Posted:

Mar 26, 2008

Last Update Posted:

May 17, 2011

Last Verified:

May 1, 2011

Additional relevant MeSH terms:

Tonsillitis

Amoxicillin

Azithromycin

Study Results

No Results Posted as of May 17, 2011