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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643539
First received: March 19, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 19, 2008
March 19, 2008
December 2002
Not Provided
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Bacteriological success or failure rate [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical success or failure rate [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Serious and non-serious adverse events (AEs) rates [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Rate of poststreptococcal complications and new disease occurrence since Day 10 [ Time Frame: Day 30 ]
Same as current
Not Provided
Not Provided
 
Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat
Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tonsillitis
  • Drug: Zithromax
    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
  • Drug: Clamoxyl
    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
  • Experimental: 1
    Intervention: Drug: Clamoxyl
  • Experimental: 2
    Intervention: Drug: Zithromax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
July 2003
Not Provided

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.

Both
3 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00643539
A0661037
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP