NCT00645073

Brief Summary

To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial sinusitis.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
271

participants targeted

Target at P75+ for phase_4

Geographic Reach
2 countries

33 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

March 27, 2008

Status Verified

March 1, 2008

Enrollment Period

4 months

First QC Date

March 22, 2008

Last Update Submit

March 22, 2008

Conditions

Acute Bacterial Sinusitis

Keywords

Acute Bacterial Sinusitis

Outcome Measures

Primary Outcomes (1)

  • Clinical cure rate

    26 days

Secondary Outcomes (2)

  • Radiographic response

    26 days

  • Changes from baseline in clinical signs and symptoms

    26 days

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: cefdinir (Omnicef)

B

ACTIVE COMPARATOR
Drug: levofloxacin

Interventions

cefdinir (Omnicef)DRUG

Two 300 mg cefdinir capsules on Study Days 1-10.

Also known as: ABT-198, Omnicef, cefdinir
A
levofloxacinDRUG

Two 250 mg levofloxacin capsules on Study Days 1-10

B

Eligibility Criteria

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

You may qualify if:

  • A female must be non-lactating, non-breastfeeding and at no risk for pregnancy.
  • A condition of general good health, based upon the results of a medical history, physical examination, and laboratory profile.
  • Subject must have a diagnosis of acute bacterial sinusitis. The diagnosis must be based on the following:
  • a sinus radiograph or CT scan performed within 48 hours pre-treatment
  • with evidence of maxillary opacification or air/fluid levels
  • Purulent discharge from the nose
  • At least one of the following clinical signs and symptoms of acute bacterial sinusitis
  • Lasting for more than 7 days prior to and no longer than 21 days before Evaluation 1: facial pain over the sinus or facial pressure over the sinus or facial tightness over the sinus or facial swelling or toothache.
  • Subject must be a suitable candidate for oral antimicrobial therapy and is able to swallow capsules intact.

You may not qualify if:

  • Subjects who have: chronic sinusitis (signs and symptoms lasting greater than 28 days prior to Evaluation 1)
  • Significant anatomical abnormalities of the sinuses
  • Any other infection or condition which necessitates use of a concomitant systemic antimicrobial.
  • History of any hypersensitivity or allergic reactions to penicillins, cephalosporins (including cefdinir), or quinolones (including levofloxacin).
  • Subject who has taken: a systemic antibiotic within 14 days before study drug administration; a long acting injectable antibiotic (e.g., penicillin G benzathine) within 30 days before study drug administration.
  • Known significant renal or hepatic impairment.
  • Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
  • Investigator considers the subject unsuitable for cefdinir or levofloxacin therapy, for any reason.
  • Previous enrollment in this study.
  • Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluations or absorption of study drug.
  • Subject who is currently receiving or who is likely to require any of the following medications during the period between Evaluation 1 (initial presentation to office/clinic) and Evaluation 3 (or within 48 hours after the last dose of study drug): Concomitant theophylline or any theophylline analog, unless plasma levels of these drugs can be adequately monitored during the study; Warfarin and probenecid.
  • Immunocompromised subjects.
  • Subject who requires parenteral antibiotic therapy for this infection or who has any other infection or condition, that necessitates use of a concomitant systemic antibiotic.
  • Subjects receiving antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc within 2 hours before or after dosing with study drug.
  • Subjects with a known or suspected central nervous system disorder that may predispose the subject to seizures or lower the seizure threshold.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Unknown Facility

Birmingham, Alabama, 35211, United States

Location

Unknown Facility

Birmingham, Alabama, 35215, United States

Location

Unknown Facility

Columbiana, Alabama, 35051, United States

Location

Unknown Facility

Eclectic, Alabama, 36024, United States

Location

Unknown Facility

Tuscaloosa, Alabama, 35406, United States

Location

Unknown Facility

Mesa, Arizona, 85201, United States

Location

Unknown Facility

Fresno, California, 93703, United States

Location

Unknown Facility

Fresno, California, 93710, United States

Location

Unknown Facility

Murray, Kentucky, 42071, United States

Location

Unknown Facility

Portage, Michigan, 49024, United States

Location

Unknown Facility

Eugene, Oregon, 97404, United States

Location

Unknown Facility

Lake Oswego, Oregon, 97035, United States

Location

Unknown Facility

Orangeburg, South Carolina, 29118, United States

Location

Unknown Facility

Kingsport, Tennessee, 37660, United States

Location

Unknown Facility

Milan, Tennessee, 38358, United States

Location

Unknown Facility

Corsicana, Texas, 75110, United States

Location

Unknown Facility

San Antonio, Texas, 78205, United States

Location

Unknown Facility

Salt Lake City, Utah, 84109, United States

Location

Unknown Facility

Salt Lake City, Utah, 84121, United States

Location

Unknown Facility

West Jordan, Utah, 84084, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Unknown Facility

Winchester, Virginia, 22601, United States

Location

Unknown Facility

Spokane, Washington, 99204, United States

Location

Unknown Facility

Gorzów Wielkopolski, 66-400, Poland

Location

Unknown Facility

Krakow, 30-510, Poland

Location

Unknown Facility

Krakow, 31-513, Poland

Location

Unknown Facility

Lodz, 90-430, Poland

Location

Unknown Facility

Lodz, 92-215, Poland

Location

Unknown Facility

Przybysławice, 322-088, Poland

Location

Unknown Facility

Skierniewice, 96-100, Poland

Location

Unknown Facility

Szczecin, 70-344, Poland

Location

Unknown Facility

Szczecin, 70-506, Poland

Location

Unknown Facility

Szczecin, 71-667, Poland

Location

MeSH Terms

Interventions

CefdinirLevofloxacin

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 22, 2008

First Posted

March 27, 2008

Study Start

November 1, 2003

Primary Completion

March 1, 2004

Last Updated

March 27, 2008

Record last verified: 2008-03

Locations

US(23)PL(10)