Amoxicillin/clavulanate tablet (625mg) plus amoxicillin capsule (500mg) is not inferior to amoxicillin/clavulanate tablet (1000mg) for treating acute bacterial rhinosinusitis

Phase 4

Completed

• Conditions: This study aimed to assess the effects of the addition of amoxicillin capsule to amoxicillin/clavulanate tablets for treating acute bacterial rhinosinusitis.; amoxicillin/clavulanate tablet (625 mg) plus amoxicillin capsule (500 mg) (AmClav625Am500), acute bacterial rhinosinusitis, amoxicillin/clavulanate tablet (1000 mg) (AmClav1000)

• Registration Number: TCTR20200308001
• Lead Sponsor: Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-08-01
• Study Start: 2020-03-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

(1) patients with ABRS using diagnostic criteria recommended by the guideline of Infectious Diseases Society of America IDSA2012 who has age between 18-75 years.

Exclusion Criteria

(1) patients identified as having ABRS with problems including orbital cellulitis, sub-periosteal abscess, orbital abscess, intracranial disorders, brain swelling, subdural empyema and meningitis, facial osteomyelitis, and clotting of the cavernous sinus and cortical vein (2) who had received amoxicillin/clavulanate within the past 3 months (3) patients with a history of hypersensitivity drugs used in the study (4) patients who are pregnant (5) patient who are breastfeeding (6) Patient who had a history of sinus surgery before.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome was cure rate at one week. 7 days For primary outcome is Cure rate which is defined by Normal Nasal endoscopy and Markedly improved na

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are Mean symptoms score at Day 7, Mean SNOT-22 at Day 7, Mean SNOT-22-rhinosinusi 7 days Secondary outcomes were symptoms, 22-item Sino-Nasal Outcome Test (SNOT-22) and adverse events.