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
Conditions
Interventions
Trade Name: Unidrox
Product Name: Unidrox
Pharmaceutical Form: Tablet
INN or Proposed INN: PRULIFLOXACIN
CAS Number: 123447-62-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Aziende Chimiche Riunite Angelini Francesco S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate at the Test Of Cure (TOC) visit, the clinical efficacy of prulifloxacin in the treatment of patients with ABRS.;Secondary Objective: i) To evaluate the microbiological efficacy of prulifloxacin in eradicating bacterial pathogens at the TOC visit; ii) To compare the clinical and microbiological outcomes; iii) To compare the results of cultures obtained at the Screening visit by Endoscopically Directed Middle Meatal (EDMM) sampling with those obtained by maxillary sinus tap (MST) through the canine fossa; iv) To assess at the (LPT) visit the clinical efficacy of prulifloxacin; v) To evaluate the safety and tolerability of the investigational drug.;Primary end point(s): At each visit, the following signs and symptoms will be graded according to a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe): nasal blockage/obstruction/congestion, nasal discharge (anterior/post nasal drip), facial pain/pressure, reduction/loss of smell. A sign or symptom is considered resolved when it is present (graded as one, two or three) pre-treatment, but becomes absent (graded as zero) at the TOC. A sign or symptom is considered worsened when its grading at the TOC visit is greater than its grading pre-treatment.The primary parameter for clinical efficacy will be the comparison of symptoms and signs scores reported at the TOC visit with those reported at the Screening.At the TOC visit, the following definitions will be used [Henry 2004]: Cure: resolution of at least 1 of the acute pre-treatment signs and symptoms (as above reported), with no worsening in the remaining signs and symptoms. Failure: no resolution of acute pre-treatment signs and symptoms (as above reported), or worsening at least 1 of the acute pre-treatment signs and symptoms, or treatment before the TOC visit with additional antibiotic therapy for ABRS. Indeterminate: presence of extenuating circumstances that precluded evaluation of the clinical response. Clinical success will be defined a | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Microbiological efficacy. At the Screening, microbiological assessment will be carried out on samples collected by EDMM, in a subset of patients,by MST,while at the TOC visit only sampling by EDMM will be performed. Results obtained at the TOC visit will be compared with those obtained at the Screening. Sampling with EDMM will represent the main reference test. Bacteriological response will be defined according to the following definitions: Eradication: the original causative organism detected at screening (by EDMM and/or MST sampling) is absent in in the secretions culture at the TOC visit. Presumed eradication: absence of appropriate culture material by EDMM at the TOC visit (i.e., no secretions from the middle meatus are available), in presence of clinical cure. Presumed persistence: absence of appropriate culture material by EDMM at the TOC visit (i.e., no secretions from the middle meatus are available), in presence of clinical failure. Persistence: the causative organism detected at screening is still present in the secretions culture at the TOC visit (the identity of the organisms isolates at the two visits should be confirmed by phenotypic and genotypic methods). Superinfection/New colonization: a new pathogen is detected from the secretions culture at the TOC visit. Indeterminate: bacteriological response not evaluable for any other reason. Bacteriological success will be defined as eradication or presumed eradication. Bacteriological failure will be defined as persistence or superinfection/new colonization or presumed persistence. Indeterminate results will be considered as not evaluable for statistical purposes and will be excluded from the analysis. The consistency and correlation of microbiological results obtained at Screening through EDMM and puncture of the maxillary sinus will be also assessed. Clinical and microbiological outcome The correlation in the individual clinical and microbiological results obtained at the TOC | — |
Countries
Romania
Contacts
Public ContactDesiderio Passali
University of Siena
Outcome results
None listed