telithromycin in respiratory tract infections

Conditions: Respiratory Tract Infections

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


Eligibility criteria:
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 exclusion criteria are: * severe pneumonia defined by any one of the following: * judged as needing intensive care unit admission. * need of parenteral antibiotic treatment (if the attending physician wants to prescribe a parenteral treatment for adherence reasons or local prescription habits this is accepted, provided that the patient does not have a severe pneumonia). * acute respiratory failure or requirement for mechanical ventilation. * altered mental status resulting from the infective process. * resting respiratory rate \> 30 breaths/min. * chest x-ray showing increase in opacity by \> 50% within 48 hours of current evaluation. * total white blood cell count \< 4 000/mm3. * aspiration pneumonia. * pneumonia suspected to be non-bacterial (due to fungus or viral). * subjects suffering from severe bronchiectasis (production of more than 125 ml of sputum/day), cystic fibrosis, active tuberculosis, pulmonary infarction or embolism, bronchial obstruction, lung cancer or lung metastasis, lung abscess, extra-pulmonary extension (like meningitis, septic arthritis, endocarditis). for aecb additional exclusion criteria are: * need of parenteral antibiotic treatment (if the attending physician wants to prescribe a parenteral treatment for adherence reasons or local prescription habits this is accepted, provided that the patient does not have a severe infection). * acute respiratory failure (respiratory distress, hypercarbia, worsening hypoxemia) or requirement for mechanical ventilation. * severe bronchiectasis, cystic fibrosis, active tuberculosis, pulmonary infarction or embolism, bronchial obstruction, lung cancer or lung metastasis, lung abscess. for as additional exclusion criteria are: * need of immediate surgery for the treatment of as. * chronic sinusitis (symptoms lasting more than 4 weeks). * recurrent sinusitis (4 or more episodes of sinusitis requiring antibiotic therapy in the previous 12 months). * nosocomial acquired sinusitis. * cystic fibrosis, immotile cilia syndrome. * obstructive lesions in nasopharynx (e.g. polyps, tumor). * use of nasal, nasogastric or nasotracheal catheters.