Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

Thammasat University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Rhinosinusitis

Interventions

cefditoren pivoxilDRUG

comparison of different dosages of cefditoren pivoxil

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Thammasat University

Prathumthani, Thailand

RECRUITING

Outcomes

Primary Outcomes

sinus symptoms scores

Change of sinus sympotms scores from baseline in 2 weeks

Time frame: 14 days

Secondary Outcomes

relapse rate

The relapse rate of sinus symptoms scores at day 28.

Time frame: at day 28

Data from ClinicalTrials.gov

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