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Telithromycin in Respiratory Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00261105
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : September 25, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE December 1, 2005
First Posted Date  ICMJE December 2, 2005
Last Update Posted Date September 25, 2009
Study Start Date  ICMJE February 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
Clinical Outcome (Global Assessment by the participating physicians) [ Time Frame: During the Study Conduct ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00261105 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
  • Rate at which additional antibacterials were prescribed to treat the primary infection [ Time Frame: During the study conduct ]
  • Rate of hospitalisation due to a complication of the primary infection [ Time Frame: During the study conduct ]
  • Assessment of chest X-ray and sinus X-ray if available. [ Time Frame: During the study conduct ]
  • Adverse Event (AE) and Serious Adverse Event (SAE) reported [ Time Frame: from the inform consent signed up to the end of the study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telithromycin in Respiratory Tract Infections
Official Title  ICMJE An Open, Multicenter, Non-comparative, Phase IV Trial of Efficacy and Safety of Ketek(Telithromycin) 800mg
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Tract Infections
Intervention  ICMJE Drug: telithromycin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00261105
Other Study ID Numbers  ICMJE HMR3647A_4026
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Won-Sik Lee, MD Sanofi
PRS Account Sanofi
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP