Steady state telithromycin pharmacokinetics and pharmacodynamic in adult patients with mild-moderate acute exacerbation of chronic obstructive pulmonary disease treated with a standard oral dose 800 mg od for 5 days - TELI AECOPD

• Conditions: Acute exacerbation of chronic-obstructive pulmonary disease.; MedDRA version: 6.1Level: PTClassification code 10029978

• Registration Number: EUCTR2006-003886-15-IT
• Lead Sponsor: SANOFI-AVENTIS S.P.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

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

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 .

Study & Design

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