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Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis (RS)

This study is currently recruiting participants.
Verified March 2012 by Thammasat University
Sponsor:
Information provided by (Responsible Party):
Orapan Poachanukoon, Thammasat University
ClinicalTrials.gov Identifier:
NCT01553006
First received: February 17, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Rhinosinusitis
 Drug: cefditoren pivoxil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Cefditoren Pivoxil 10 mg/kg/Day and Cefditoren Pivoxil 20 mg/kg/Day in Treatment of Childhood With Acute Rhinosinusitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thammasat University:

Primary Outcome Measures:
  • sinus symptoms scores [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Change of sinus sympotms scores from baseline in 2 weeks


Secondary Outcome Measures:
  • relapse rate [ Time Frame: at day 28 ] [ Designated as safety issue: Yes ]
    The relapse rate of sinus symptoms scores at day 28.


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cefditoren pivoxil
cefditoren 10 mg/kg/day for 14 days
 Drug: cefditoren pivoxil
comparison of different dosages of cefditoren pivoxil
Other Name: Meiact
Active Comparator: cefditoren pivoxil high dose
cefditoren 20 MKD were used to compare efficacy of treatment.
 Drug: cefditoren pivoxil
comparison of different dosages of cefditoren pivoxil
Other Name: Meiact

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.

  Eligibility

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

  • poor compliance
  • other infections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553006

Locations
Thailand
Thammasat University Recruiting
Prathumthani, Thailand, 12120
Contact: Orapan Poachanukoon, MD.     66819316781     orapanpoachanukoon@yahoo.com    
Sponsors and Collaborators
Thammasat University
Investigators
Principal Investigator: Orapan Poachanukoon, MD. Thammasat University
  More Information

No publications provided

Responsible Party: Orapan Poachanukoon, Associate Professor, Thammasat University
ClinicalTrials.gov Identifier: NCT01553006     History of Changes
Other Study ID Numbers: MTU-EC-PE-5-036/54
Study First Received: February 17, 2012
Last Updated: March 13, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Thammasat University:
rhinosinusitis
cefditoren pivoxil

Additional relevant MeSH terms:
Nose Diseases
Sinusitis
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Cefditoren pivoxil
 Cefditoren
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013