Status:
COMPLETED
Telithromycin in Respiratory Tract Infections
Lead Sponsor:
Sanofi
Conditions:
Respiratory Tract Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00261105
Start Date
February 1 2005
End Date
December 1 2005
Last Update
September 25 2009
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