An open-label, randomized, multicenter, clinical study to comparethe effects of telithromycin, azithromycin and cefuroxime axetilon the penicillin or macrolide resistance of Streptococcus pneumoniaein patients with acute exacerbation of chronic bronchitis - Perspective

• Conditions: Patients with acute exacerbation of chronic bronchitis

• Registration Number: EUCTR2004-001412-30-HU
• Lead Sponsor: aboratoire Aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5660

Inclusion Criteria

Patients meeting all of the following criteria will be considered for enrollment into the study:
·Outpatients, male or female, aged 35 years or older
·Patient with a documented history of chronic bronchitis, characterized by cough and excessive sputum production for most days of at least three months for 2 consecutive years,
And
·Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis, presumed due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume;
·Patients producing spontaneous sputum;
·Patients with three or less AECB in the previous 12 months

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

·Patients with a known diagnosis of bronchiectasis, cystic fibrosis, lung cancer or lung metastases, active pulmonary tuberculosis or with suspected pneumonia;
·Patients with present acute respiratory failure or patients requiring aggressive airway management;
·Hospitalized patients and patients from institutional care facilities;
·Patients treated with antibiotics within 14 days prior to enrollment;
·Patients who are receiving other medications, including systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety;
·Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making either implementation of the protocol or interpretation of the study results difficult;
·Patients with a progressively fatal disease, or life expectancy = three months;
·Patients who have received any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period;
·Patients with a recent (within the previous three months) history of alcohol or drug abuse;
·Immunocompromised patients including but not limited to: Patients with known HIV infection (CD4 + <200/mm3), known neutropenia (<1500 neutrophils/mm3), chronic corticosteroid therapy (³ 10mg/day prednisolone equivalent during at least three months), immunodepressant treatment within the previous six months, splenectomized patients or patients with known hyposplenia or asplenia;
·Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study;
·Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and are unlikely to complete the study;
·Patients having received anti-pneumococcal immunization in the previous six months before study entry;
·Patients with suspected or known hypersensitivity to, or suspected serious adverse reaction to the study medication, or to ß-lactams or macrolides classes of antibiotics;
·Patients diagnosed with myasthenia gravis;
·Women who are breast-feeding or who are pregnant;
·Women who are of childbearing potential who do not agree to use an approved contraceptive method during the study;
·Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
·Patients with a known history of long QTc syndrome (e.g., personal or family history of syncope or arrhythmia);
·Patients treated within 2 weeks prior to study entry, or requiring treatment during study medication, with CYP3A4 inducers such as rifampicin, phenytoïn, carbamazepine, phenobarbital, and St John’s Wort;
·Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol (see section 6.2);
·Patients known to have impaired hepatic function;
·Patients known to have impaired renal function;
·Patients already enrolled in this study

Study & Design

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