Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

Phase 4

• Conditions: Rhinosinusitis
• Interventions: Drug: cefditoren pivoxil

• Registration Number: NCT01553006
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-17
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14
• Primary Completion: 2012-08
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria

• poor compliance
• other infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cefditoren pivoxil	cefditoren pivoxil	cefditoren 10 mg/kg/day for 14 days
cefditoren pivoxil high dose	cefditoren pivoxil	cefditoren 20 MKD were used to compare efficacy of treatment.

Primary Outcome Measures

Name	Time	Method
sinus symptoms scores	14 days	Change of sinus sympotms scores from baseline in 2 weeks

Secondary Outcome Measures

Name	Time	Method
relapse rate	at day 28	The relapse rate of sinus symptoms scores at day 28.

Trial Locations

Locations (1)

Thammasat University; 🇹🇭 Prathumthani, Thailand