Acute exacerbation of chronic-obstructive pulmonary disease. MedDRA version: 6.1 Level: PT Classification code 10029978
Conditions
Interventions
Trade Name: KETEK*10CPR RIV 400MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Telithromycin
CAS Number: 173838-31-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
SANOFI-AVENTIS S.P.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult inpatients, either sex, aged 18 years or older; documented history of mild-moderate chronic bronchitis/chronic obstructive pulmonary disease COPD as defined by ERS/ATS criteria and with a basal FEV1 / 50 and with FEV1 / FVC / 70 and who have had at least one or more episode of acute exacerbation in the previous year; clinical diagnosis of AECOPD based on the following clinical signs and symptoms at least two of any of the following Winnipeg II increased in sputum purulence change in color and/or increased in sputum volume and/or increased dyspnea with or without other symptoms like fever, cough, ect.; sufficient volumes of spontaneous sputum to permit collection of specimens for gram stain and bacteriological culture; negative chest radiography posterior/anterior and lateral views to rule out a diagnosis of pneumonia within 48 hours before initiation of study medication or at the latest 24 hours after initiation of study medication. 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: Main criteria in relation with study protocol current asthma, with a known diagnosis of bronchiectasis, cystic fibrosis, lung cancer or lung metastases, or active pulmonary tuberculosis; acute respiratory failure or patients requiring aggressive airway management; requiring parenteral antibiotic therapy; treated with antibiotics within 30 days prior to enrollment; with a maintenance oral corticosteroid therapy; with known impaired renal function serum creatinine 1.5 mg/dL ; immunocompromission. Main criteria in relation with study treatment with known impaired hepatic function sGOT, sGPT or serum bilirubin more than 2-fold the normal values ; with suspected or known hypersensitivity to, or suspected serious adverse reaction to the study medication, or macrolide class of antibiotics; with a known history of long QTc syndrome e.g., personal or family history of syncope or arrhythmia ; treated within 2 weeks prior inclusion, or requiring treatment during study medication, with CYP3A4 inducers such as rifampicine, phenyto n, carbamazepine, phenobarbital, and St John s Wort; who will require on-study treatment with medications known to have contraindicated drug interactions with the study medication and/or macrolides, in general, including but not limited to ergot alkaloid derivatives, terfenadine, cisapride, astemizole, pimozide, bromocriptine, cabergoline, pergolide and statins for those patients who are not allowed to stop their statin treatment simvastatin, lovastatin, atorvastatin .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate, in explorative manner, in adult patients with mild-moderate AECOPD, treated orally with telithromycin 800 mg od for 5 days the pharmacokinetic profile of telithromycin in plasma at the steady-state.;Secondary Objective: To describe the pharmacokinetic-pharmacodynamic profile of telithromycin in plasma at the steady-state;the relationship between the pharmacokinetic-pharmacodynamic profile of telithromycin in plasma at the steady-state and the clinical cure and satisfactory bacteriological response rate; the clinical and bacteriological response at the end of therapy visit D 6-7 ; the time to symptoms amelioration/resolution; the safety of telithromycin.;Primary end point(s): The primary variable will be the pharmacokinetic evaluation at the steady-state conditions, that is after at least four days of unmodified treatment dose and time schedule . | — |
Countries
Italy
Outcome results
None listed