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

Thammasat University

Status and phase: Unknown; Phase 4

Conditions: Rhinosinusitis

Treatments: Drug: cefditoren pivoxil

Study type: Interventional

Funder types: Other

Identifiers

NCT01553006

MTU-EC-PE-5-036/54

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion criteria

• poor compliance
• other infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

cefditoren pivoxil

Active Comparator group

Description:

cefditoren 10 mg/kg/day for 14 days

Treatment:

Drug: cefditoren pivoxil

cefditoren pivoxil high dose

Active Comparator group

Description:

cefditoren 20 MKD were used to compare efficacy of treatment.

Treatment:

Drug: cefditoren pivoxil