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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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