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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01553006
Recruitment Status : Unknown
Verified March 2012 by Orapan Poachanukoon, Thammasat University.
Recruitment status was:  Recruiting
First Posted : March 13, 2012
Last Update Posted : March 14, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Rhinosinusitis Drug: cefditoren pivoxil Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Secondary Outcome Measures :
  1. relapse rate [ Time Frame: at day 28 ]
    The relapse rate of sinus symptoms scores at day 28.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012

Keywords provided by Orapan Poachanukoon, Thammasat University:
rhinosinusitis
cefditoren pivoxil

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