Respiratory Tract Infections
Conditions
Brief summary
Primary Objectives: * The primary objective of the study is to evaluate clinical efficacy i.e. to show that with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community acquired respiratory tract infections: community acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in outpatients. Secondary Objectives: The secondary objectives are to: * Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which additional antibacterials were prescribed to treat the primary infection; the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data, chest X-ray and sinus X-ray if available. * Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting
Interventions
DRUGtelithromycin
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Conditions * Outpatients * Fulfillment of clinical diagnostic criteria for one of the following indications: * Mild to moderate Community Acquired Pneumonia (CAP) * Acute bacterial Exacerbation of Chronic Bronchitis (AECB) * Acute Sinusitis (AS) For CAP The Criteria to be fulfilled are: * New onset of at least two of the following: * Cough * Production of purulent sputum * Auscultatory findings compatible with pneumonia, e.g. rales, evidence of pulmonary consolidation * Dyspnea or tachypnea * Fever * Elevated total white blood cell count \> 10 000/mm3 or \>15% bands regardless of total count * Chest X-ray findings supporting a clinical diagnosis of bacterial pneumonia (e.g. new infiltrate) For AECB The Criteria to be fulfilled are: * Chronic bronchitis defined as cough and excessive sputum production for more than 2 consecutive years and on most days in a 3-month consecutive period. * Exacerbation defined by: * Increase in sputum purulence, or * Increase in sputum volume, or * Increase in dyspnea For AS The criteria to be fulfilled are: At least two of the major or one major and two minor factors listed below, for more than one week and less than 4 weeks: * Major factors: * Facial pressure and/or pain * Facial congestion or fullness * Nasal obstruction * Nasal purulence or postnasal discharge * Hyposmia or anosmia * Fever * Minor factors: * Headache * Halitosis * Fatigue * Dental pain * Cough * Ear pain, pressure or fullness
Exclusion criteria
General Conditions Subjects presenting with any of the following will not be included in the study: * Treatment required during the study with ergot alkaloid derivatives, pimozide, astemizole, terfenadine, cisapride, simvastatin, atorvastatin and lovastatin, and the oral use of the benzodiazepines midazolam, triazolam and alprazolam. * History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation. * Known hypersensitivity to telithromycin or to macrolide antibiotics. * Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry). * Pregnant or breast-feeding women. For the women of childbearing potential it is left to the investigators discretion to establish a lack of pregnancy, e.g. with contraceptive use, menstrual pattern, urinary pregnancy test. * Subjects with severely impaired renal function (creatinine clearance \<30 ml/min). * Subjects that had received anti-bacterials for more than 24 hours within 7 days prior to enrollment in the study, unless the treatment has failed. * Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation. * Microbiologically documented infection with a pathogen known prior to inclusion to be resistant to the study medications. * Infection, other than the primary infection for which the subject is being included in the study that requires use of other systemic anti-bacterial drug. * Splenectomised subjects. * Use of Ketek® (telithromycin) or participation in a study using Ketek® (telithromycin) in the previous 30 calendar days. * Subjects that have received any investigational drug within 4 weeks of enrollment in the study. * No subject will be allowed to enroll in this study more than once. For CAP Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Outcome (Global Assessment by the participating physicians) | During the Study Conduct |
Secondary
| Measure | Time frame |
|---|---|
| Rate at which additional antibacterials were prescribed to treat the primary infection | During the study conduct |
| Rate of hospitalisation due to a complication of the primary infection | During the study conduct |
| Assessment of chest X-ray and sinus X-ray if available. | During the study conduct |
| Adverse Event (AE) and Serious Adverse Event (SAE) reported | from the inform consent signed up to the end of the study |
Outcome results
None listed