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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Thammasat University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Orapan Poachanukoon, Thammasat University
ClinicalTrials.gov Identifier:
NCT01553006
First received: February 17, 2012
Last updated: March 13, 2012
Last verified: March 2012

February 17, 2012
March 13, 2012
January 2012
August 2012   (final data collection date for primary outcome measure)
sinus symptoms scores [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Change of sinus sympotms scores from baseline in 2 weeks
Primary outcome (response rate) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Change of sinus sympotms score at 2 weeks
Complete list of historical versions of study NCT01553006 on ClinicalTrials.gov Archive Site
relapse rate [ Time Frame: at day 28 ] [ Designated as safety issue: Yes ]
The relapse rate of sinus symptoms scores at day 28.
Secondary outcome (relapse rate) [ Time Frame: at day 28 ] [ Designated as safety issue: Yes ]
The relapse rate was recorded at day 28.
Not Provided
Not Provided
 
Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Rhinosinusitis
Drug: cefditoren pivoxil
comparison of different dosages of cefditoren pivoxil
Other Name: Meiact
  • Active Comparator: cefditoren pivoxil
    cefditoren 10 mg/kg/day for 14 days
    Intervention: Drug: cefditoren pivoxil
  • Active Comparator: cefditoren pivoxil high dose
    cefditoren 20 MKD were used to compare efficacy of treatment.
    Intervention: Drug: cefditoren pivoxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

  • poor compliance
  • other infections
Both
1 Year to 15 Years
Yes
Not Provided
Thailand
 
NCT01553006
MTU-EC-PE-5-036/54
Yes
Orapan Poachanukoon, Thammasat University
Thammasat University
Not Provided
Principal Investigator: Orapan Poachanukoon, MD. Thammasat University
Thammasat University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP