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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200308001

Enrollment

Registered

2020-03-08

Start date

2017-06-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study aimed to assess the effects of the addition of amoxicillin capsule to amoxicillin/clavulanate tablets for treating acute bacterial rhinosinusitis. acute bacterial rhinosinusitis&#44

Interventions

Group B patients received amoxicillin/clavulanate tablet (1000 mg) (AmClav1000) twice daily for 7 days. ,Group A patient received amoxicillin/clavulanate tablet (625 mg) plus amoxicillin capsule (500

Active Comparator Drug,Active Comparator Drug

patients received amoxicillin/clavulanate tablet (1000 mg) (AmClav1000) twice daily for 7 days. ,patient received amoxicillin/clavulanate tablet (625 mg) plus amoxicillin capsule (500 mg) (

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactAtidtaya Chimchua

Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University

doctoratid@hotmail.com0890576900

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026