Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

Overview

Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about the efficacy of this drug at low and high doses.

Full Title of Study: “A Comparison of Cefditoren Pivoxil 10 mg/kg/Day and Cefditoren Pivoxil 20 mg/kg/Day in Treatment of Childhood With Acute Rhinosinusitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: August 2012

Detailed Description

The investigation was a randomized, investigator-blinded, and parallel study, conducted in patients (age 1-15 years) with acute rhinosinusitis. Two groups of patients were randomized received low (10 MKD) or high (20 MKD) of drug for 14 days. Changes in sinus symptoms scores, response rate and adverse effect were evaluated at days 7 and 14. Relapse rate was recorded at days 21 and 28. Recurrence of sinus symptoms at day 60 were assessed.

Interventions

  • Drug: cefditoren pivoxil
    • comparison of different dosages of cefditoren pivoxil

Arms, Groups and Cohorts

  • Active Comparator: cefditoren pivoxil
    • cefditoren 10 mg/kg/day for 14 days
  • Active Comparator: cefditoren pivoxil high dose
    • cefditoren 20 MKD were used to compare efficacy of treatment.

Clinical Trial Outcome Measures

Primary Measures

  • sinus symptoms scores
    • Time Frame: 14 days
    • Change of sinus sympotms scores from baseline in 2 weeks

Secondary Measures

  • relapse rate
    • Time Frame: at day 28
    • The relapse rate of sinus symptoms scores at day 28.

Participating in This Clinical Trial

Inclusion Criteria

  • children age 1-15 years old diagnosed acute rhinosinusitis Exclusion Criteria:

  • poor compliance – other infections

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Thammasat University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Orapan Poachanukoon, Associate Professor – Thammasat University
  • Overall Official(s)
    • Orapan Poachanukoon, MD., Principal Investigator, Thammasat University

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