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

aboratoire Aventis0 sites5,660 target enrollmentSeptember 16, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: aboratoire Aventis
Enrollment: 5660
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 16, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

aboratoire Aventis

Eligibility Criteria

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,
•·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

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;