EVALUATION OF THE CLINICAL AND MICROBIOLOGICAL EFFICACY OF N-ACETILCISTEINA 600 MG, IN COMBINATION TO CEFPODOXIMA PROXETILE, IN THE THERAPY OF THE INFECTIONS OF THE HIGH RESPIRATORY WAYS IN ADULT PATIENTS CLINICAL STUDY MULTICENTRIC, TO GROUPS PARALLELS, DOUBLE - BLIND VS PLACEBO - ND

• Conditions: Infection of the high respiratory ways in adult patients; MedDRA version: 9.1Level: HLTClassification code 10004054Term: Bacterial upper respiratory tract infections

• Registration Number: EUCTR2007-000260-24-IT
• Lead Sponsor: ZAMBON ITALIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Patients will be included in the study males and females, of age comprised between the 18 and 75 years, affections from recurrent acute infections or subacute/of the high respiratory ways rinosinusitis, faringotonsillitis, infections of the medium ear , to probable bacterial aetiology. The clinical diagnosis, may to be confirmed afterward from the microbiological medical report, based on the isolation, the identification and the test of sensibility of the pathogenic one to cefpodoxima antibiogramme . Waiting for turned out of laboratory, the decision to include equally the patient comes remitted to the responsability of the single clinical Experimenter. In this case the patient, treaty empirically, would like afterward excluded from the primary analysis of effectivity in case she turns out you of the tests microbiological were denied infection to you to aetiology turns them or insensibility of the bacteria she isolates you to the treatment with cefpodoxime .
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Hypersensitivity to drugs in study or other antibiotics beta-lattamici or one whichever of excipients - Previous anaphylactic reactions or other serious reactions to other antibiotics beta-lattamici - serious Pathologies like the respiratory clogging or a faringeo abscess, whose main symptoms are intense disfagia, impossibility to swallow also it salted it, fever much elevating, dyspnoea, respiratory stridore - Assessed fenilchetonuria - Suspects infection from Pseudomonas - Asthma like main primitiva affection/ - allergic Rhinitis - Assessed batteremia, meningitis or infection of the next woven ones to the paranasals breasts - Assessed immunodeficiency neutropenia, on counts of neutrophil 1000 mm3 - Women in state of assessed or presumed pregnancy, in breast-feeding and those in age fertile that, in the period of observation, do not adopt an effective contraceptive system estroprogestinici, I.U.D., condom, spermicidal diaphragm with cream, etc - Patients with clearance ofthe creatinine 40 ml/minute. The clearance of the creatinine it will be estimated from the values of the creatinine in the serum, using the formula of Cockcroft and Gault paragraph 8,5 - Patients who had assumed antibiotic in the 5 previous days enlistment in the study - Patients enlists in other clinical experimentations in the three previous months enlistment to you in the study - Patients with pathologies or therapies that can interfere with the appraisal of the treatments in study - Necessity of different an antibiotic therapy from those specified in the study - Patients who, to judgment of the Experimenter, introduce other conditions that they can interfere with the compliance to the treatment and/or the previewed procedures and therefore with the corrected execution of the study - Pathologies that, to judgment of the Experimenter, could not benefit from some of the therapies proposed from the study protocol.

Study & Design

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