Maxillary Sinusitis Clinical Trial
Official title:
An Open-label, Multi-center, Non-comparative Sinus Puncture Study of 750 mg, Short-course Levofloxacin in the Treatment of Acute Maxillary Sinusitis
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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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