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

March 13, 2012 updated by: Orapan Poachanukoon, Thammasat University

A Comparison of Cefditoren Pivoxil 10 mg/kg/Day and Cefditoren Pivoxil 20 mg/kg/Day in Treatment of Childhood With Acute Rhinosinusitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

  • poor compliance
  • other infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Meiact

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapse rate
Time Frame: at day 28
The relapse rate of sinus symptoms scores at day 28.
at day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Orapan Poachanukoon, MD., Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-PE-5-036/54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rhinosinusitis

Clinical Trials on cefditoren pivoxil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe