Clinical trial NCT00643539: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 360
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
timeFrame: Day 10
Secondary outcomes:
measure: Bacteriological success or failure rate
timeFrame: Day 30
measure: 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
timeFrame: Day 10
measure: Clinical success or failure rate
timeFrame: Day 30
measure: Serious and non-serious adverse events (AEs) rates
timeFrame: continuous
measure: Rate of poststreptococcal complications and new disease occurrence since Day 10
timeFrame: Day 30
Other outcomes:
Locations:
city: Ancenis
country: France
facility: Pfizer Investigational Site
city: Asnieres Sur Seine
country: France
facility: Pfizer Investigational Site
city: Auch
country: France
facility: Pfizer Investigational Site
city: Boulogne
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Brive
country: France
facility: Pfizer Investigational Site
city: Cannes La Boca
country: France
facility: Pfizer Investigational Site
city: Chalons En Champagne
country: France
facility: Pfizer Investigational Site
city: Chambery
country: France
facility: Pfizer Investigational Site
city: Champigny sur Marne
country: France
facility: Pfizer Investigational Site
city: Combs La Ville
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Draguignan
country: France
facility: Pfizer Investigational Site
city: Draguignan
country: France
facility: Pfizer Investigational Site
city: Essey Les Nancy
country: France
facility: Pfizer Investigational Site
city: Lagny
country: France
facility: Pfizer Investigational Site
city: Les Sables D'olonne
country: France
facility: Pfizer Investigational Site
city: Les Ulis
country: France
facility: Pfizer Investigational Site
city: Levallois Perret
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Massy
country: France
facility: Pfizer Investigational Site
city: Meudon La Foret
country: France
facility: Pfizer Investigational Site
city: Meysieu
country: France
facility: Pfizer Investigational Site
city: Millery
country: France
facility: Pfizer Investigational Site
city: Nogent Sur Marne
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Saint Marcel
country: France
facility: Pfizer Investigational Site
city: Saint Quentin
country: France
facility: Pfizer Investigational Site
city: Salon de Provence
country: France
facility: Pfizer Investigational Site
city: Sartrouville
country: France
facility: Pfizer Investigational Site
city: Selestat
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Thionville
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Tresses
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Pfizer Investigational Site
city: Varois Et Chaignot
country: France
facility: Pfizer Investigational Site
city: Vence
country: France
facility: Pfizer Investigational Site
city: Versailles
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: