MedDataX Logo

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

NCT ID: NCT00643149

Last Updated: 2011-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

693 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00644293

Pharyngitis Tonsillitis
COMPLETED PHASE3

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

NCT00643539

Tonsillitis
COMPLETED PHASE4

A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

NCT00643292

Acute Otitis Media
COMPLETED PHASE3

A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

NCT00393835

Upper Respiratory Tract Infection
COMPLETED PHASE3

TELI TON - Telithromycin in Tonsillitis

NCT00315042

Tonsillitis Pharyngitis
TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tonsillitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

amoxicillin

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

azithromycin SR

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

amoxicillin

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Hoover, Alabama, United States

Site Status

Pfizer Investigational Site

Pelham, Alabama, United States

Site Status

Pfizer Investigational Site

Fresno, California, United States

Site Status

Pfizer Investigational Site

Fresno, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Evansville, Indiana, United States

Site Status

Pfizer Investigational Site

Evansville, Indiana, United States

Site Status

Pfizer Investigational Site

Evansville, Indiana, United States

Site Status

Pfizer Investigational Site

Newburgh, Indiana, United States

Site Status

Pfizer Investigational Site

Newburgh, Indiana, United States

Site Status

Pfizer Investigational Site

Wichita, Kansas, United States

Site Status

Pfizer Investigational Site

Wichita, Kansas, United States

Site Status

Pfizer Investigational Site

Bardstown, Kentucky, United States

Site Status

Pfizer Investigational Site

Springfield, Kentucky, United States

Site Status

Pfizer Investigational Site

Kalamazoo, Michigan, United States

Site Status

Pfizer Investigational Site

Endwell, New York, United States

Site Status

Pfizer Investigational Site

Raleigh, North Carolina, United States

Site Status

Pfizer Investigational Site

Beachwood, Ohio, United States

Site Status

Pfizer Investigational Site

Chesterland, Ohio, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Willoughby, Ohio, United States

Site Status

Pfizer Investigational Site

Youngstown, Ohio, United States

Site Status

Pfizer Investigational Site

McMurray, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Bryan, Texas, United States

Site Status

Pfizer Investigational Site

Lake Jackson, Texas, United States

Site Status

Pfizer Investigational Site

Salt Lake City, Utah, United States

Site Status

Pfizer Investigational Site

Salt Lake City, Utah, United States

Site Status

Pfizer Investigational Site

Salt Lake City, Utah, United States

Site Status

Pfizer Investigational Site

Salt Lake City, Utah, United States

Site Status

Pfizer Investigational Site

West Jordan, Utah, United States

Site Status

Pfizer Investigational Site

Calgary, Alberta, Canada

Site Status

Pfizer Investigational Site

Coquitlam, British Columbia, Canada

Site Status

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

Site Status

Pfizer Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Pfizer Investigational Site

Escazú, Provincia de San José, Costa Rica

Site Status

Pfizer Investigational Site

San José, Provincia de San José, Costa Rica

Site Status

Pfizer Investigational Site

Uruca, Provincia de San José, Costa Rica

Site Status

Pfizer Investigational Site

San José, , Costa Rica

Site Status

Pfizer Investigational Site

Guatemala City, Departamento de Guatemala, Guatemala

Site Status

Pfizer Investigational Site

Hyderabad, Andhara Pradesh, India

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Kochi, Kerala, India

Site Status

Pfizer Investigational Site

Mumbai, Maharashtra, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Costa Rica Guatemala India

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661071&StudyName=A%20Multicenter%2C%20Randomized%2C%20Double-Blind%2C%20Double-Dummy%20Study%20Of%20Azithromycin%20SR%20Versus%20Amoxicillin%20For%20The%20Treatment%20Of%20Strep%20Throat%20In

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A0661071

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
NCT00944515 COMPLETED NA
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
NCT00796224 COMPLETED PHASE2
Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
NCT00939185 COMPLETED
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
NCT01919996 TERMINATED PHASE2
TELI COM - Telithromycin in Children With Otitis Media
NCT00315003 TERMINATED PHASE3
Once-daily Therapy for Streptococcal Pharyngitis
NCT01310361 COMPLETED PHASE1
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
NCT04669288 TERMINATED PHASE3
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
NCT00393744 COMPLETED PHASE3
TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
NCT00315549 TERMINATED PHASE3
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
NCT01486758 COMPLETED PHASE2
Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora
NCT00354952 COMPLETED NA
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
NCT05026749 RECRUITING PHASE3
Mycoplasma Infection Rate and Macrolides Resistance in Children With Acute Respiratory Tract Infection
NCT04126304 UNKNOWN
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 PHASE3
Treatment of Macrolide-resistant Mycoplasma Pneumoniae
NCT03530319 UNKNOWN NA
Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children
NCT02707523 COMPLETED PHASE2
Comparative Effectiveness of Antibiotics for Respiratory Infections
NCT02297815 COMPLETED
Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II
NCT02911935 COMPLETED PHASE2/PHASE3
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
NCT00645112 COMPLETED PHASE4
Effects of the Direct Interaction Between Streptococcus Salivarius 24SMBc and Streptococcus Oralis 89a and the Respiratory Epithelium in Children
NCT03449836 UNKNOWN PHASE3
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients
NCT00643227 COMPLETED PHASE3
Bacteriological Study of Acute Follicular Tonsillitis
NCT04321733 UNKNOWN
Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy
NCT02307825 COMPLETED PHASE4
A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects
NCT01818011 TERMINATED PHASE1
Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment
NCT04083417 RECRUITING PHASE4