Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

Rhinosinusitis Clinical Trial

— RS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01553006
• Other study ID #: MTU-EC-PE-5-036/54
• Status: Recruiting
• Phase: Phase 4
• First received: February 17, 2012
• Last updated: March 13, 2012
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: March 2012
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

• children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

• poor compliance

• other infections

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinosinusitis
• Sinusitis

Intervention

Drug:
• cefditoren pivoxil
comparison of different dosages of cefditoren pivoxil

Locations

Country	Name	City	State
Thailand	Thammasat University	Prathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sinus symptoms scores	Change of sinus sympotms scores from baseline in 2 weeks	14 days	Yes
Secondary	relapse rate	The relapse rate of sinus symptoms scores at day 28.	at day 28	Yes