NCT00335309

Brief Summary

The purpose of this study is to evaluate the effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis, a prospective randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

7.8 years

First QC Date

June 8, 2006

Last Update Submit

October 6, 2013

Conditions

Sinusitis

Keywords

chronic rhinosinusitissinus irrigation

Outcome Measures

Primary Outcomes (1)

  • CT Scoring

    on recruiting and follow-up

Secondary Outcomes (2)

  • Quality of life Questionaire

    on recruiting and follow-up

  • Nasal Endoscopy score

    upon recruiting and follow-up

Study Arms (2)

1

EXPERIMENTAL

The Investigational arm is treated with sinus irrigation with normal saline 0.9% and intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department.

Procedure: Maxillary Sinus Irrigation

2

ACTIVE COMPARATOR

The control arm is treated with the same intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. There is no sinus irrigation with normal saline for this arm. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department.

Drug: IV Amoxicillin and Clavulanate acid

Interventions

Maxillary Sinus IrrigationPROCEDURE

Twice a day irrigation with 100cc saline for 4 days

1
IV Amoxicillin and Clavulanate acidDRUG

IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic (over 3 months) maxillary and ethmoidal rhinosinusitis (verified by a CT scan)
  • Over 18 years of age
  • Signed informed consent
  • Not participating in another clinical study

You may not qualify if:

  • A previous sinonasal surgery or craniofacial trauma
  • Isolated frontal or sphenoidal sinusitis
  • Immunosuppressed (diabetes, cancer, etc.)
  • Craniofacial deformity
  • Allergic fungal sinusitis
  • Nasal polyposis
  • Rhinosinusitis of dental origin
  • Bleeding tendency (e.g., chronic coumadin treatment)
  • Patients participating in other clinical study
  • Patients with penicillin allergy
  • Patients with Augmentin resistant bacteria in cultures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel MC

Haifa, 34362, Israel

Location

Related Publications (3)

  • Benninger MS, Sedory Holzer SE, Lau J. Diagnosis and treatment of uncomplicated acute bacterial rhinosinusitis: summary of the Agency for Health Care Policy and Research evidence-based report. Otolaryngol Head Neck Surg. 2000 Jan;122(1):1-7. doi: 10.1016/S0194-5998(00)70135-5.

    PMID: 10629474BACKGROUND

  • Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995 Jul;113(1):104-9. doi: 10.1016/S0194-59989570152-4.

    PMID: 7603703BACKGROUND

  • Benninger MS, Appelbaum PC, Denneny JC, Osguthorpe DJ, Stankiewicz JA. Maxillary sinus puncture and culture in the diagnosis of acute rhinosinusitis: the case for pursuing alternative culture methods. Otolaryngol Head Neck Surg. 2002 Jul;127(1):7-12. doi: 10.1067/mhn.2002.124847.

    PMID: 12161724BACKGROUND

MeSH Terms

Conditions

Sinusitis

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ohad Ronen, MD

    ENT Department, Carmel Medical Center, Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ENT Physician

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 9, 2006

Study Start

October 1, 2005

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

IL(1)