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Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox (SPEED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00668304
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):

Brief Summary:
This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis.

Condition or disease Intervention/treatment Phase
Maxillary Sinusitis Drug: Avelox (Moxifloxacin, BAY12-8039) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Open, Uncontrolled Trial to Evaluate the Time to Bacterial Eradication and Key Symptom Relief in the Treatment of Acute Bacterial Maxillary Sinusitis With Moxifloxacin 400 mg QD
Study Start Date : June 2004
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Experimental: Arm 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg once orally daily

Primary Outcome Measures :
  1. Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae [ Time Frame: Days 1, 2, 3 of treatment ]

Secondary Outcome Measures :
  1. Patient-reported symptom improvement using SNOT-16 questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ]
  2. Clinical Response [ Time Frame: End of Treatment ]
  3. Bacteriological Response [ Time Frame: End of Treatment ]
  4. Activity Impairment Assessment questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ]
  5. Incidence of Premature Termination [ Time Frame: Premature Termination ]
  6. Adverse Events Collection [ Time Frame: Up to End of Treatment (Day 10-13) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of acute sinusitis with signs and symptoms present for >7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:a. The presence of 1 or more of the following on a radiographic paranasal sinus film (Waters' view) or limited CT scan:** evidence of air-fluid levels** opacification. The presence of at least one major and one minor symptom as defined in the list below:** Major Symptoms*** Purulent anterior or posterior nasal discharge*** Unilateral moderate or severe facial pain or malar tenderness** Minor Symptoms*** Cough or frequent throat clearing*** Frontal headache*** Halitosis*** Fever (oral > 38.0°C/100.4°F, tympanic > 38.5°C/101.2°F)*** Purulent secretions obtained via middle meatus secretion sampling using nasal endoscopic technique; the specimen sent for Gram stain, culture and susceptibility testing prior to initiation of antimicrobial therapy

Exclusion Criteria:

  • History of chronic sinusitis defined as greater than four weeks of continuous symptoms (patients with history of sinus surgery may be included; patients with recurrent sinusitis may be included)
  • Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses- Received systemic antibacterial therapy likely to be effective in sinusitis for more than 24 hours within 7 days of enrollment- A requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol- Known immunodeficiency diseases including AIDS (CD4 <200)- On topical nasal or systemic corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment- History of allergy to quinolone antibiotics or related compounds- Pregnant or breast feeding- Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
  • Received an investigational drug in the past 30 days- Unable to take oral medication- Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
  • End stage liver cirrhosis (class Child-Pugh C)- Severe renal impairment requiring dialysis
  • Previous history of tendinopathy associated with quinolones- Any symptoms that suggest that the patient's current illness is allergic rhinitis (e.g., repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
  • Diagnosis of rapidly fatal illness with a life expectance of less than 6 months- Previously enrolled in this clinical study- Uncorrected hypokalaemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00668304

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer Identifier: NCT00668304     History of Changes
Other Study ID Numbers: 100569
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Additional relevant MeSH terms:
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Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs