A Study Evaluating the Safety and Efficacy of Treating Si... | NCT00236652

Studies
A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.

NCT00236652

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Status

Completed

Last Update Posted

Jun 10, 2011Estimated

Enrollment

18Actual

Phase

Phase 3

Conditions

Maxillary Sinusitis

Interventions

levofloxacin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Nov 2003

Primary Completion Date

Not provided

Completion Date

Jun 2005Actual

First Submitted Date

Oct 7, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2011

Last Update Posted Date

Jun 10, 2011Estimated

Name	Class
PriCara, Unit of Ortho-McNeil, Inc.	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of a once-daily administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating bacterial sinus infections.

Detailed Description

Acute bacterial sinusitis is a common diagnosis for which an antibiotic is prescribed in outpatients. Some types of bacteria that cause sinusitis are resistant to penicillin and certain other classes of antibiotics, but may be treatable with the antibiotic levofloxacin. This will be an open-label, multi-center, non-comparative clinical trial involving outpatients with protocol-defined acute bacterial sinusitis suitable for treatment with oral antibiotics. At the Preliminary Visit, a sinus radiograph will be obtained to confirm the clinical diagnosis of sinusitis, and the Investigator will perform a nasal exam. Sinus puncture and placement of an indwelling sinus catheter into an affected maxillary sinus will be performed on all eligible patients at the first visit. Patients meeting the study criteria will receive 750 milligrams levofloxacin tablets once daily for 5 days. The primary objective is to establish the rate and extent of bacteriological eradication, defined as eradication of pathogens from the maxillary sinus, and to establish the effectiveness and safety of once-daily 750 milligrams levofloxacin for the treatment of acute bacterial sinusitis in adults.

Levofloxacin 750 milligram tablet orally once a day for 5 days

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Name	Type	Description	Arm Group Labels	Other Names
levofloxacin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: Clinical response on Day 5 and at the Post-Therapy Visit (Days 12-19); plasma and sinus aspirate concentrations on Days 2-4; levels of inflammatory mediators on Days 0-5. Safety: Adverse events, vital signs, and clinical laboratory tests.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical signs and symptoms of acute maxillary sinusitis for 5 to 28 days
Visible nasal purulence evident on physical examination
CT scan or standard sinus x-ray (Waters' projections) performed within 5 days prior to the first dose of study drug, showing total sinus opacification or an air-fluid level
Agree to a maxillary sinus puncture and catheter placement
If female, using birth control

Exclusion Criteria:

Chronic sinusitis
Need for hospitalization or intravenous antibiotics
History of head, neck, or nasal cancer or surgery
Previous allergy, serious adverse reaction to, or failed therapy with, levofloxacin or any other member of the quinolone class
Presence or history of serious complications of sinusitis
Previous antimicrobial therapy within 7 days of Study Entry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17178300	Result	Anon JB, Paglia M, Xiang J, Ambrose PG, Jones RN, Kahn JB. Serial sinus aspirate samples during high-dose, short-course levofloxacin treatment of acute maxillary sinusitis. Diagn Microbiol Infect Dis. 2007 Jan;57(1):105-7. doi: 10.1016/j.diagmicrobio.2006.10.019.

ID	Term
D015523	Maxillary Sinusitis
D007239	Infections

ID	Term
D012852	Sinusitis
D012141	Respiratory Tract Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

ID	Term
D015242	Ofloxacin
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones