Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the T… (NCT00493038) | Clinical Trial Compass
TerminatedPhase 4
Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
Stopped: The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
Italy293 participantsStarted 2006-02
Plain-language summary
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis
Who can participate
Age range18 Years
SexALL
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:
* Age \>= 18 years
* Clinical diagnosis of acute rhinosinusitis with signs and symptoms present for \>/= 5-7 days but \< 28 days
* Clinical diagnosis will be confirmed by nasal endoscopic examination
Exclusion Criteria:
* History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included)
* Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
* Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
* Known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count \< 1000/mm3), human immunodeficiency virus (HIV) infection (Cluster of differentiation 4 (CD4)+ T-cell count of \< 200/mm3). Note: HIV testing is not required
* Received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment
* Requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol
* Currently receiving topical nasal corticosteroids, unless they have been on a stable dose for \> 4 weeks prior to enrollment
* Requirement for concomitant therapy with systemic corticosteroids
* Pregnant or breast feeding
* Of childbeari…
What they're measuring
1
Number of Participants With Response (Per-protocol Population)
Timeframe: At 'Test-of-Cure', Day 1-3 after treatment