Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusi… (NCT00668304) | Clinical Trial Compass
CompletedPhase 4
Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox
United States, Argentina192 participantsStarted 2004-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tho…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae