Infection of the high respiratory ways in adult patients MedDRA version: 9.1 Level: HLT Classification code 10004054 Term: Bacterial upper respiratory tract infections
Conditions
Interventions
Trade Name: FLUIMUCIL
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: n acetilcisteina
Current Sponsor code: NAC600
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
ZAMBON ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the proportion of patients with complete remission of the symptomatology or same reduction of equal or the advanced one to the 90 , estimated after 3 maximum 4 days of treatment.;Secondary Objective: - to estimate the microbiological eradication of the etiological agents after 3 maximum 4 days of treatment and to visit TOC Test of Cures, to the day 2 1 after fine treatment - to estimate the clinical efficacy remission of the symptomatology or same reduction of equal or the advanced one to 90 to visit TOC and the visit of follow-up 10-14 days from the term of the therapy - to estimate the speed of resolution of the symptomatology of the infection - to determine the incidence of complicanze and/or recidive in the period of follow - to estimate the acceptability of the treatment from part of the patient - to estimate the tollerability of the supplied therapy - to estimate the topical necessity of a second prescription during the period of follow-up decongestant, analgesic, anti-inflammatory, antipyretics, cortisonici for via nasal to stable doses, etc ;Primary end point(s): It will constitute variable primary the proportion of patients with complete remission of the symptomatology or same reduction of equal or the advanced one to the 90 , estimated after 3 maximum 4 days of treatment. | — |
Countries
Italy
Outcome results
None listed