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Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

Primary Purpose

Tonsillitis

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Zithromax

Clamoxyl

About this trial

This is an interventional treatment trial for Tonsillitis

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Outpatients with an acute pharyngitis erythematous or erythematopultaceous with modification of pharynx aspect and fever of ≥38° C, and patients either with or without spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node (mandibular area) were eligible for inclusion. All subjects should have had a positive rapid strep test and a positive culture for Group A beta-hemolytic streptococcus.

Exclusion Criteria:

Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Bacteriologic success (Eradication: elimination of the original GABS; or Colonization: elimination of the original GABS but isolation of another stain of GABS) or failure (Persistence: presence of original GABS on repeated culture samples) rate

Secondary Outcome Measures

Bacteriological success or failure rate

Clinical success (resolution of signs and symptoms, or sufficient improvement; no additional antibacterial therapy indicated) or failure (insufficient improvement or worsening of signs and symptoms; additional antibacterial therapy indicated) rate

Clinical success or failure rate

Serious and non-serious adverse events (AEs) rates

Rate of poststreptococcal complications and new disease occurrence since Day 10

Full Information

NCT ID

NCT00643539

First Posted

March 19, 2008

Last Updated

March 19, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00643539

Brief Title

Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

Official Title

Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.

6. Conditions and Keywords

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

Tonsillitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Zithromax

Intervention Description

azithromycin (Zithromax) pediatric suspension formulation (200 mg/5 ml) administered as an oral suspension at a dose of 20 mg/kg once a day (maximal dose 500 mg/day) for 3 consecutive days

Intervention Type

Drug

Intervention Name(s)

Clamoxyl

Intervention Description

Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days

Primary Outcome Measure Information:

Title

Time Frame

Day 10

Secondary Outcome Measure Information:

Title

Bacteriological success or failure rate

Time Frame

Day 30

Title

Time Frame

Day 10

Title

Clinical success or failure rate

Time Frame

Day 30

Title

Serious and non-serious adverse events (AEs) rates

Time Frame

continuous

Title

Rate of poststreptococcal complications and new disease occurrence since Day 10

Time Frame

Day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Outpatients with an acute pharyngitis erythematous or erythematopultaceous with modification of pharynx aspect and fever of ≥38° C, and patients either with or without spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node (mandibular area) were eligible for inclusion. All subjects should have had a positive rapid strep test and a positive culture for Group A beta-hemolytic streptococcus. Exclusion Criteria: Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.

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

Ancenis

ZIP/Postal Code

44150

Country

France

Facility Name

Pfizer Investigational Site

City

Asnieres Sur Seine

ZIP/Postal Code

92600

Country

France

Facility Name

Pfizer Investigational Site

City

Auch

ZIP/Postal Code

32000

Country

France

Facility Name

Pfizer Investigational Site

City

Boulogne

ZIP/Postal Code

92100

Country

France

Facility Name

Pfizer Investigational Site

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Pfizer Investigational Site

City

Brive

ZIP/Postal Code

19100

Country

France

Facility Name

Pfizer Investigational Site

City

Cannes La Boca

ZIP/Postal Code

06150

Country

France

Facility Name

Pfizer Investigational Site

City

Chalons En Champagne

ZIP/Postal Code

51000

Country

France

Facility Name

Pfizer Investigational Site

City

Chambery

ZIP/Postal Code

73000

Country

France

Facility Name

Pfizer Investigational Site

City

Champigny sur Marne

ZIP/Postal Code

94500

Country

France

Facility Name

Pfizer Investigational Site

City

Combs La Ville

ZIP/Postal Code

77380

Country

France

Facility Name

Pfizer Investigational Site

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Pfizer Investigational Site

City

Draguignan

ZIP/Postal Code

33170

Country

France

Facility Name

Pfizer Investigational Site

City

Draguignan

ZIP/Postal Code

83300

Country

France

Facility Name

Pfizer Investigational Site

City

Essey Les Nancy

ZIP/Postal Code

54270

Country

France

Facility Name

Pfizer Investigational Site

City

Lagny

ZIP/Postal Code

77400

Country

France

Facility Name

Pfizer Investigational Site

City

Les Sables D'olonne

ZIP/Postal Code

85100

Country

France

Facility Name

Pfizer Investigational Site

City

Les Ulis

ZIP/Postal Code

91940

Country

France

Facility Name

Pfizer Investigational Site

City

Levallois Perret

ZIP/Postal Code

92300

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

ZIP/Postal Code

13006

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

ZIP/Postal Code

13013

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

ZIP/Postal Code

13014

Country

France

Facility Name

Pfizer Investigational Site

City

Massy

ZIP/Postal Code

91300

Country

France

Facility Name

Pfizer Investigational Site

City

Meudon La Foret

ZIP/Postal Code

92360

Country

France

Facility Name

Pfizer Investigational Site

City

Meysieu

ZIP/Postal Code

69330

Country

France

Facility Name

Pfizer Investigational Site

City

Millery

ZIP/Postal Code

69390

Country

France

Facility Name

Pfizer Investigational Site

City

Nogent Sur Marne

ZIP/Postal Code

94130

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75004

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75005

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Pfizer Investigational Site

City

Saint Marcel

ZIP/Postal Code

71380

Country

France

Facility Name

Pfizer Investigational Site

City

Saint Quentin

ZIP/Postal Code

02100

Country

France

Facility Name

Pfizer Investigational Site

City

Salon de Provence

ZIP/Postal Code

13300

Country

France

Facility Name

Pfizer Investigational Site

City

Sartrouville

ZIP/Postal Code

78500

Country

France

Facility Name

Pfizer Investigational Site

City

Selestat

ZIP/Postal Code

67600

Country

France

Facility Name

Pfizer Investigational Site

City

Strasbourg

ZIP/Postal Code

67100

Country

France

Facility Name

Pfizer Investigational Site

City

Thionville

ZIP/Postal Code

57100

Country

France

Facility Name

Pfizer Investigational Site

City

Tours

ZIP/Postal Code

37000

Country

France

Facility Name

Pfizer Investigational Site

City

Tresses

ZIP/Postal Code

33370

Country

France

Facility Name

Pfizer Investigational Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54500

Country

France

Facility Name

Pfizer Investigational Site

City

Varois Et Chaignot

ZIP/Postal Code

21490

Country

France

Facility Name

Pfizer Investigational Site

City

Vence

ZIP/Postal Code

06140

Country

France

Facility Name

Pfizer Investigational Site

City

Versailles

ZIP/Postal Code

78000

Country

France

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661037&StudyName=Multicenter%2C%20Open%2C%20Randomized%20Comparative%20Trial%20To%20Compare%20The%20Efficacy%20Of%20Azithromycin%20Versus%20Amoxicillin%20In%20Children%20With%20Strep%20Throat

Description

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Learn more about this trial

Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

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Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

Tonsillitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial