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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

Primary Purpose

Pharyngitis, Tonsillitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
azithromycin (Zithromax)
placebo
azithromycin SR
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS

Exclusion Criteria:

  • Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

bacteriologic response in the Bacteriologic per Protocol population

Secondary Outcome Measures

sponsor assessment of clinical response in the Bacteriologic per Protocol population
bacteriologic response for the remaining study populations
sponsor assessment of clinical response for the Bacteriologic per Protocol population
bacteriologic response for the Bacteriologic per Protocol population
summary of baseline susceptibilities
adverse events

Full Information

First Posted
March 19, 2008
Last Updated
June 3, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00644293
Brief Title
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults
Official Title
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis, Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
598 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
azithromycin (Zithromax)
Intervention Description
azithromycin 500 mg tablet by mouth once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
azithromycin SR
Intervention Description
azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
bacteriologic response in the Bacteriologic per Protocol population
Time Frame
Test of Cure (TOC) visit (Days 24-28)
Secondary Outcome Measure Information:
Title
sponsor assessment of clinical response in the Bacteriologic per Protocol population
Time Frame
TOC visit
Title
bacteriologic response for the remaining study populations
Time Frame
TOC visit
Title
sponsor assessment of clinical response for the Bacteriologic per Protocol population
Time Frame
Long-Term Follow-Up (LTFU) visit (Days 38-45)
Title
bacteriologic response for the Bacteriologic per Protocol population
Time Frame
TOC visit
Title
summary of baseline susceptibilities
Time Frame
Study endpoint
Title
adverse events
Time Frame
Continuous

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS Exclusion Criteria: Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83651
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83703
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83709
Country
United States
Facility Name
Pfizer Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Pfizer Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83651
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Pfizer Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Pfizer Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Pfizer Investigational Site
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
Facility Name
Pfizer Investigational Site
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Pfizer Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Pfizer Investigational Site
City
Erembodegem
ZIP/Postal Code
9320
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Nokia
ZIP/Postal Code
37100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
Pfizer Investigational Site
City
Courbevoie
ZIP/Postal Code
92 400
Country
France
Facility Name
Pfizer Investigational Site
City
Gentilly
ZIP/Postal Code
94 250
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
ZIP/Postal Code
34 000
Country
France
Facility Name
Pfizer Investigational Site
City
Rouen
ZIP/Postal Code
76 100
Country
France
Facility Name
Pfizer Investigational Site
City
Villejuif
ZIP/Postal Code
94 800
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10965
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13593
Country
Germany
Facility Name
Pfizer Investigational Site
City
Erkner
ZIP/Postal Code
15537
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ludwigshafen
ZIP/Postal Code
67069
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ruedersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Pfizer Investigational Site
City
Tostedt
ZIP/Postal Code
D-21255
Country
Germany
Facility Name
Pfizer Investigational Site
City
Villingen-Schwenningen
ZIP/Postal Code
78054
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 0344
Country
India
Facility Name
Pfizer Investigational Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682 026
Country
India
Facility Name
Pfizer Investigational Site
City
Hyderabad
ZIP/Postal Code
500 033
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
ZIP/Postal Code
411 004
Country
India
Facility Name
Pfizer Investigational Site
City
Foligno
State/Province
PG
ZIP/Postal Code
06034
Country
Italy
Facility Name
Pfizer Investigational Site
City
Gualdo Tadino
State/Province
PG
ZIP/Postal Code
06023
Country
Italy
Facility Name
Pfizer Investigational Site
City
S.Eraclio-Foligno
State/Province
PG
ZIP/Postal Code
06087
Country
Italy
Facility Name
Pfizer Investigational Site
City
Spoleto
State/Province
PG
ZIP/Postal Code
06049
Country
Italy
Facility Name
Pfizer Investigational Site
City
Vocabolo Gaifana-Gualdo Tadino
State/Province
PG
ZIP/Postal Code
06020
Country
Italy
Facility Name
Pfizer Investigational Site
City
Ede (Gld)
ZIP/Postal Code
6711 PS
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Geldermalsen
ZIP/Postal Code
4191 AH
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Huizen
ZIP/Postal Code
1271 BB
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Elverum
ZIP/Postal Code
2402
Country
Norway
Facility Name
Pfizer Investigational Site
City
Skedsmokorset
ZIP/Postal Code
2020
Country
Norway
Facility Name
Pfizer Investigational Site
City
Bath
State/Province
Avon
ZIP/Postal Code
BA2 3HT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Hastings
State/Province
East Sussex
ZIP/Postal Code
TN34 3EY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glenrothes
State/Province
Fife
ZIP/Postal Code
KY6 3LQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
High Valleyfield
State/Province
Fife
ZIP/Postal Code
KY12 8SJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Tunbrige Wells
State/Province
Kent
ZIP/Postal Code
TN1 2EP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Atherstone
State/Province
Warwickshire
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV7 8LA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Kent
ZIP/Postal Code
TN1 2DX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Kent
ZIP/Postal Code
TN10 3ET
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Kent
ZIP/Postal Code
TN11 9HL
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661119&StudyName=A%20Multicenter%2C%20Randomized%2C%20Double-Blind%2C%20Double-Dummy%20Comparative%20Trial%20of%20Azithromycin%20Sustained%20Release%20Versus%203-Day%20Azithromycin%20for%20th
Description
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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

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