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PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis

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: NCT00132938
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE August 18, 2005
First Posted Date  ICMJE August 22, 2005
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE January 2004
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
Presence of PERSp in sputum of patients at the TOC visit in each treatment group and who were Sp positive in sputum at Visit 1.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
Assessment of clinical signs and symptoms of AECB at EOT visit for the global efficacy analysis population & at TOC visit for patients who were Sp positive in sputum at visit 1.Bacteriological data at EOT and TOC visits. Assessment of safety...
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 PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis
Official Title  ICMJE An Open-label, Randomized, Multicenter, Clinical Study to Compare the Effects of Telithromycin, Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis
Brief Summary

Primary Objective:

  • The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1).

Secondary Objectives:

The secondary objectives of the study are:

  • To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1);
  • To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits;
  • To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1);
  • To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Bronchitis
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
 (submitted: June 29, 2006)
5660
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients meeting all of the following criteria will be considered for enrollment into the study:

  • Outpatients, male or female, aged 35 years or older
  • Patients with a documented history of chronic bronchitis, characterized by cough and excessive sputum production for most days of at least three months for 2 consecutive years
  • Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis (AECB), presumed due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume
  • Patients producing spontaneous sputum
  • Patients with three or less AECB in the previous 12 months

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

  • Patients with a known diagnosis of bronchiectasis; cystic fibrosis; lung cancer or lung metastases; active pulmonary tuberculosis; or with suspected pneumonia.
  • Patients with present acute respiratory failure or patients requiring aggressive airway management
  • Hospitalized patients and patients from institutional care facilities
  • Patients treated with antibiotics within 14 days prior to enrollment
  • Patients who are receiving other medications, including systemic antimicrobial agents; or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety.
  • Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making either implementation of the protocol or interpretation of the study results difficult
  • Patients with a progressively fatal disease, or life expectancy ≤ three months
  • Patients who have received any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period
  • Patients with a recent (within the previous three months) history of alcohol or drug abuse
  • Immunocompromised patients including, but not limited to: patients with known HIV infection (CD4 + <200/mm3); known neutropenia (<1500 neutrophils/mm3); chronic corticosteroid therapy (≥ 10mg/day prednisolone equivalent during at least three months); immunodepressant treatment within the previous six months; splenectomized patients or patients with known hyposplenia or asplenia.
  • Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study
  • Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and are unlikely to complete the study
  • Patients having received anti-pneumococcal immunization in the previous six months before study entry
  • Patients with suspected or known hypersensitivity to, or suspected serious adverse reactions to the study medication, or to ß-lactams or macrolide classes of antibiotics
  • Patients diagnosed with myasthenia gravis
  • Women who are breast-feeding or who are pregnant
  • Women who are of childbearing potential who do not agree to use an approved contraceptive method during the study
  • Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption
  • Patients with a known history of long QTc syndrome (e.g., personal or family history of syncope or arrhythmia)
  • Patients treated within 2 weeks prior to study entry, or requiring treatment during study medication, with CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, and St John's wort
  • Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol
  • Patients known to have impaired hepatic function
  • Patients known to have impaired renal function
  • Patients already enrolled in this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 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 Belgium,   France,   Hungary,   Morocco,   Spain,   Tunisia,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00132938
Other Study ID Numbers  ICMJE HMR3647A_4020
EudraCT # :2004-001412-30
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: Gilles Perdriset, MD Sanofi
PRS Account Sanofi
Verification Date June 2011

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