Telithromycin in Respiratory Tract Infections
Study Details
Study Description
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.
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Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- Clinical Outcome (Global Assessment by the participating physicians) [During the Study Conduct]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
General Conditions
-
Outpatients
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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:
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New onset of at least two of the following:
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Cough
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Production of purulent sputum
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Auscultatory findings compatible with pneumonia, e.g. rales, evidence of pulmonary consolidation
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Dyspnea or tachypnea
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Fever
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Elevated total white blood cell count > 10 000/mm3 or >15% bands regardless of total count
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Chest X-ray findings supporting a clinical diagnosis of bacterial pneumonia (e.g. new infiltrate)
For AECB
The Criteria to be fulfilled are:
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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.
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Exacerbation defined by:
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Increase in sputum purulence, or
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Increase in sputum volume, or
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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:
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Major factors:
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Facial pressure and/or pain
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Facial congestion or fullness
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Nasal obstruction
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Nasal purulence or postnasal discharge
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Hyposmia or anosmia
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Fever
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Minor factors:
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Headache
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Halitosis
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Fatigue
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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.
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History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation.
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Known hypersensitivity to telithromycin or to macrolide antibiotics.
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Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry).
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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.
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Subjects with severely impaired renal function (creatinine clearance <30 ml/min).
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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.
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Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation.
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Microbiologically documented infection with a pathogen known prior to inclusion to be resistant to the study medications.
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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.
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Splenectomised subjects.
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Use of Ketek® (telithromycin) or participation in a study using Ketek® (telithromycin) in the previous 30 calendar days.
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Subjects that have received any investigational drug within 4 weeks of enrollment in the study.
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No subject will be allowed to enroll in this study more than once.
For CAP
Additional exclusion criteria are:
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Severe pneumonia defined by any one of the following:
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Judged as needing Intensive Care Unit admission.
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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).
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Acute respiratory failure or requirement for mechanical ventilation.
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Altered mental status resulting from the infective process.
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Resting respiratory rate > 30 breaths/min.
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Chest X-ray showing increase in opacity by > 50% within 48 hours of current evaluation.
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Total white blood cell count < 4 000/mm3.
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Aspiration pneumonia.
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Pneumonia suspected to be non-bacterial (due to fungus or viral).
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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).
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Acute respiratory failure (respiratory distress, hypercarbia, worsening hypoxemia) or requirement for mechanical ventilation.
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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:
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Need of immediate surgery for the treatment of AS.
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Chronic sinusitis (symptoms lasting more than 4 weeks).
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Recurrent sinusitis (4 or more episodes of sinusitis requiring antibiotic therapy in the previous 12 months).
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Nosocomial acquired sinusitis.
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Cystic fibrosis, immotile cilia syndrome.
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Obstructive lesions in nasopharynx (e.g. polyps, tumor).
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Use of nasal, nasogastric or nasotracheal catheters.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Won-Sik Lee, MD, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HMR3647A_4026