Telithromycin in Respiratory Tract Infections

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00261105
First received: December 1, 2005
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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

Condition Intervention Phase
Respiratory Tract Infections
Drug: telithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Multicenter, Non-comparative, Phase IV Trial of Efficacy and Safety of Ketek(Telithromycin) 800mg

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Clinical Outcome (Global Assessment by the participating physicians) [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate at which additional antibacterials were prescribed to treat the primary infection [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Rate of hospitalisation due to a complication of the primary infection [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Assessment of chest X-ray and sinus X-ray if available. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Adverse Event (AE) and Serious Adverse Event (SAE) reported [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]

Study Start Date: February 2005
Study Completion Date: December 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261105

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Won-Sik Lee, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00261105     History of Changes
Other Study ID Numbers: HMR3647A_4026
Study First Received: December 1, 2005
Last Updated: September 24, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014