Prulifloxacin in ABRS

• Conditions: facial pain/pressure; reduction/loss of smell. Persistent symptoms for 10 days or an increase of symptoms after 5 days, and with a duration lower then 12 weeks.; Male or female adults with ABRS, defined as the presence of 2 (including at least one between nasal blockage/congestion/ obstruction or nasal discharge) or more of the following signs and symptoms: nasal blockage/congestion/obstruction; nasal discharge (anterior/post nasal drip); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-002955-33-RO
• Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-04
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or female adults (age > 18 years) with no limitation of race using an appropriate birth control method.
2. Patients with Acute Bacterial Rhinosinusitis (ABRS) defined as a superinfection of a pre-existing Acute Viral Rhinosinusitis characterized by persistent symptoms for 10 days or an increase of symptoms after 5 days, and with a duration lower than 12 weeks
3. Clinical diagnosis of ABRS defined as the presence of two (including at least one between nasal blockage/congestion/obstruction or nasal discharge) or more of the following signs and symptoms
- nasal blockage/congestion/obstruction,
- nasal discharge: anterior/post nasal drip,
- facial pain/pressure,
- reduction/loss of smell.
4.Clinical diagnosis of moderate/severe ABRS
5.Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent prior to the inclusion in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Known hypersensitivity or allergy to prulifloxacin or other fluoroquinolone antibacterials and/or to any component of the prulifloxacin tablet.
2. Known hypersensitivity or allergy to substances used for topical or intravenous anesthesia/sedation (only for patients requiring anesthesia/sedation related to diagnostic procedures)
3. Nosocomial sinus infection or infections following or associated with naso-tracheal intubation.
4. Chronic rhinosinusitis (duration of symptoms for more than 12 weeks) or complicated rhinosinusitis (brain abscess or venous trombosis).
5. Nasal polyps. The absence of nasal polyps should be endoscopically confirmed.
6. Patients with nasal anatomic abnormalities (i.e., septum deviation) that not allowed or impaired the middle meatus visualization and/or sampling.
7. History of sinus surgery.
8. History of tendinopathy associated with use of fluoroquinolones.
9. Childbearing potential where pregnancy is not excluded by pregnancy test in urine (ß-HCG), or lactation.
10. Patients with latent or known deficiencies for the glucose-6-phosphate dehydrogenase, or with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
11. Known severe liver and/or renal insufficiency (AST, ALT, ?-GT and/or creatinine levels more than twice as high as the Upper Laboratory Norm).
12.Immunosuppressed patients or patients with cystic fibrosis.
13. Concurrent infections and/or neoplasm.
14. Concomitant treatment with hypoglycemic drugs.
15. Concomitant treatment with xanthines.
16. Treatment with antibiotics or antibacterials within the previous week.
17. Treatment with experimental drugs in the previous 4 weeks.
18. Positive history for drugs and alcohol abuse. Patients who had an alcohol or drugs abuse within 24 h before the enrollment in the present study will be also excluded.
19. Inability to comply with the protocol requirements, instructions and study-related restrictions (i.e., uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study).
20. Vulnerable subjects (i.e., persons kept in detention).
21. The patient is the Investigator or his/her deputies, first grade relatives, assistant, pharmacist, or other personnel directly involved in the study conduct.
22. Participation to an interventional clinical trial within 3 months prior to the Screening visit prior to the inclusion in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified