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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Orapan Poachanukoon, Thammasat University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Orapan Poachanukoon, Thammasat University Identifier:
First received: February 17, 2012
Last updated: March 13, 2012
Last verified: March 2012
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
Intervention Model: Parallel Assignment
Masking: Single (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:

Further study details as provided by Orapan Poachanukoon, Thammasat University:

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

Secondary Outcome Measures:
  • relapse rate [ Time Frame: at day 28 ]
    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.

Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

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

Thammasat University Recruiting
Prathumthani, Thailand, 12120
Contact: Orapan Poachanukoon, MD.    66819316781   
Sponsors and Collaborators
Thammasat University
Principal Investigator: Orapan Poachanukoon, MD. Thammasat University
  More Information

Responsible Party: Orapan Poachanukoon, Associate Professor, Thammasat University 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

Keywords provided by Orapan Poachanukoon, Thammasat University:
cefditoren pivoxil

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Cefditoren pivoxil
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 21, 2017