TonsillitisPhase 4NCT00643539

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

A Phase 4 study testing Zithromax and Clamoxyl in people with Tonsillitis, run by Pfizer at 45 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 3 to 15 years
Conditions the study is for: Tonsillitis
What is being tested?: Zithromax and Clamoxyl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 45 sitesFrance
Study dates: Dec 2002to Jul 2003
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

France45 sites

Pfizer Investigational Site
Ancenis, 44150
Pfizer Investigational Site
Asnières-sur-Seine, 92600
Pfizer Investigational Site
Auch, 32000
Pfizer Investigational Site
Boulogne, 92100
Pfizer Investigational Site
Brest, 29200
Pfizer Investigational Site
Brivé, 19100
Pfizer Investigational Site
Cannes LA BOCA, 06150
Pfizer Investigational Site
Châlons-en-Champagne, 51000
Pfizer Investigational Site
Chambéry, 73000
Pfizer Investigational Site
Champigny-sur-Marne, 94500
Pfizer Investigational Site
Combs-la-Ville, 77380
Pfizer Investigational Site
Dijon, 21000
Pfizer Investigational Site
Draguignan, 33170
Pfizer Investigational Site
Draguignan, 83300
Pfizer Investigational Site
Essey-lès-Nancy, 54270
Pfizer Investigational Site
Lagny, 77400
Pfizer Investigational Site
Les Sables-d'Olonne, 85100
Pfizer Investigational Site
Les Ulis, 91940
Pfizer Investigational Site
Levallois-Perret, 92300
Pfizer Investigational Site
Marseille, 13006
Pfizer Investigational Site
Marseille, 13013
Pfizer Investigational Site
Marseille, 13014
Pfizer Investigational Site
Massy, 91300
Pfizer Investigational Site
Meudon-la-Forêt, 92360
Pfizer Investigational Site
Meysieu, 69330
Pfizer Investigational Site
Millery, 69390
Pfizer Investigational Site
Nogent-sur-Marne, 94130
Pfizer Investigational Site
Paris, 75004
Pfizer Investigational Site
Paris, 75005
Pfizer Investigational Site
Paris, 75015
Pfizer Investigational Site
Paris, 75019
Pfizer Investigational Site
Paris, 75020
Pfizer Investigational Site
Saint-Marcel, 71380
Pfizer Investigational Site
Saint-Quentin, 02100
Pfizer Investigational Site
Salon-de-Provence, 13300
Pfizer Investigational Site
Sartrouville, 78500
Pfizer Investigational Site
Sélestat, 67600
Pfizer Investigational Site
Strasbourg, 67100
Pfizer Investigational Site
Thionville, 57100
Pfizer Investigational Site
Tours, 37000
Pfizer Investigational Site
Tresses, 33370
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54500
Pfizer Investigational Site
Varois-et-Chaignot, 21490
Pfizer Investigational Site
Vence, 06140
Pfizer Investigational Site
Versailles, 78000

Other trials in France

About this study

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

Conditions: Tonsillitis
Being tested: Zithromax, Clamoxyl
Medical subject headings: Tonsillitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZithromaxDrug
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
ClamoxylDrug
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

Study groups in NCT00643539
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Clamoxyl
2	Experimental	Not described Receives: Drug: Zithromax

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 10

Secondary outcomes (5)

Bacteriological success or failure rate
Measured: Day 30
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
Measured: Day 10
Clinical success or failure rate
Measured: Day 30
Serious and non-serious adverse events (AEs) rates
Measured: continuous
Rate of poststreptococcal complications and new disease occurrence since Day 10
Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2002Jul 2003

First posted26 Mar 2008 (estimated)
Study startDec 2002
Study completionJul 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for TonsillitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00643539
Sponsor's protocol ID: A0661037
Status last verified: Mar 2008
First submitted: 19 Mar 2008
Last updated: 26 Mar 2008
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
Active, not recruiting
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillitis Recurrent
Recruiting
Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Peritonsillar Abscess, Peritonsillar Cellulitis

All Tonsillitis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis
ClinicalTrials.gov ID: NCT00643539
Acronym / sponsor ID: A0661037
Conditions: Tonsillitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2002
Study completion: Jul 2003 (actual)
First posted: 26 Mar 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Clamoxyl
2	Experimental	Drug: Zithromax

Who may qualify

Ages: 3 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zithromaxazithromycin (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	Drug	2
ClamoxylAmoxicillin (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	Drug	1

Primary outcome

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
Time frame: Day 10

5 secondary outcomes

Bacteriological success or failure rate
Time frame: Day 30
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
Time frame: Day 10
Clinical success or failure rate
Time frame: Day 30
Serious and non-serious adverse events (AEs) rates
Time frame: continuous
Rate of poststreptococcal complications and new disease occurrence since Day 10
Time frame: Day 30

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2008.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Tonsillitis

Not yet recruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
Active, not recruiting
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillitis Recurrent
Recruiting
Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess
Peritonsillar Abscess, Peritonsillar Cellulitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

45 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zithromax and Clamoxyl in people with Tonsillitis, run by Pfizer at 45 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00643539.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2008.