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

Primary Purpose

Rhinosinusitis

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

cefditoren pivoxil

About this trial

This is an interventional treatment trial for Rhinosinusitis focused on measuring rhinosinusitis, cefditoren pivoxil

Eligibility Criteria

1 Year - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

poor compliance
other infections

Sites / Locations

Thammasat UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

cefditoren pivoxil

cefditoren pivoxil high dose

Arm Description

cefditoren 10 mg/kg/day for 14 days

cefditoren 20 MKD were used to compare efficacy of treatment.

Outcomes

Primary Outcome Measures

sinus symptoms scores

Change of sinus sympotms scores from baseline in 2 weeks

Secondary Outcome Measures

relapse rate

The relapse rate of sinus symptoms scores at day 28.

Full Information

NCT ID

NCT01553006

First Posted

February 17, 2012

Last Updated

March 13, 2012

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT01553006

Brief Title

Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

Acronym

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 Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

August 2012 (Anticipated)

Study Completion Date

September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinosinusitis

Keywords

rhinosinusitis, cefditoren pivoxil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cefditoren pivoxil

Arm Type

Active Comparator

Arm Description

cefditoren 10 mg/kg/day for 14 days

Arm Title

cefditoren pivoxil high dose

Arm Type

Active Comparator

Arm Description

cefditoren 20 MKD were used to compare efficacy of treatment.

Intervention Type

Drug

Intervention Name(s)

cefditoren pivoxil

Other Intervention Name(s)

Meiact

Intervention Description

comparison of different dosages of cefditoren pivoxil

Primary Outcome Measure Information:

Title

sinus symptoms scores

Description

Change of sinus sympotms scores from baseline in 2 weeks

Time Frame

14 days

Secondary Outcome Measure Information:

Title

relapse rate

Description

The relapse rate of sinus symptoms scores at day 28.

Time Frame

at day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: children age 1-15 years old diagnosed acute rhinosinusitis Exclusion Criteria: poor compliance other infections

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orapan Poachanukoon, MD.

Organizational Affiliation

Thammasat University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thammasat University

City

Prathumthani

ZIP/Postal Code

12120

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Orapan Poachanukoon, MD.

Phone

66819316781

orapanpoachanukoon@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

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