Telithromycin in Respiratory Tract Infections
- Conditions
- Respiratory Tract Infections
- Registration Number
- NCT00261105
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical Outcome (Global Assessment by the participating physicians) During the Study Conduct
- Secondary Outcome Measures
Name Time Method 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