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Outpatient Registry Trial of Respiratory Tract Infections in Adults

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ClinicalTrials.gov Identifier: NCT00245453
Recruitment Status : Withdrawn (Terminated by sponsor)
First Posted : October 28, 2005
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Sanofi
Information provided by:
CPL Associates

Tracking Information
First Submitted Date  ICMJE October 26, 2005
First Posted Date  ICMJE October 28, 2005
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
  • Time to bacterial eradication [ Time Frame: 11-18 days ]
  • Bacteriologic outcome [ Time Frame: 11-18 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2005)
Time to bacterial eradication
Change History Complete list of historical versions of study NCT00245453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2005)
Bacteriologic outcome
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outpatient Registry Trial of Respiratory Tract Infections in Adults
Official Title  ICMJE Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)
Brief Summary To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.
Detailed Description To Evaluate the relationship between rate of S. pneumoniae killing in sputum, PK/PD, and clinical response of oral telithromycin and azithromycin in patients with AECB or CAP and to determine if there is a difference in the rates of infection site bacterial killing (as described above) between these 3 antibiotics against penicillin- and erythromycin-resistant S.pneumoniae
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
  • Pneumonia, Bacterial
  • Bronchitis, Chronic
Intervention  ICMJE
  • Drug: azithromycin
    250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5
  • Drug: telithromycin
    400 mg tablets; 2 tablets once daily (QD) for 5 days
  • Drug: Clarythromycin
    500 mg extended release tablets; 2 tablets QD for 7 days
Study Arms  ICMJE
  • Active Comparator: 1 Azithromycin
    Intervention: Drug: azithromycin
  • Active Comparator: 2 Clarythromycin
    Intervention: Drug: Clarythromycin
  • Active Comparator: 3 Telithromycin
    Intervention: Drug: telithromycin
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 30, 2007)
0
Original Enrollment  ICMJE
 (submitted: October 26, 2005)
100
Actual Study Completion Date  ICMJE July 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of CAP or AECB who are amenable to serial nasopharyngeal and oropharyngeal sampling and having positive Binax-NOW tests indicating infection with Streptococcus pneumoniae
  • Patients with a medical history and clinical findings consistent with a respiratory tract infection. A patient with advanced COPD, repeated exacerbations by history, a BINAX-NOW test consistent with S. pneumoniae and/or proven culture positivity for S. pneumoniae may be enrolled
  • All patients (CAP or AECB) must produce purulent sputum and be positive on the Urinary BINAX-NOW assay.
  • The female patient of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or IUD). The patient must agree to continue with the same method throughout the study.

Exclusion Criteria:

  • Baseline sputum cultures known to be negative for S. pneumoniae, or negative urinary BINAX-NOW.
  • Patients with a microbiologically documented pathogen known prior to inclusion to be resistant to any of the study medications.
  • History of hypersensitivity to macrolides, azalides, ketolide antibiotics or history of serious hypersensitivity reaction to any drug.
  • Pre-existing impaired hepatic function or impaired renal function CCL <20ml/min
  • Patients who will require on-study treatment with medications known to have contraindicated drug interactions with telithromycin
  • Treatment with more than one dose of an antimicrobial prior to entry into the study

Others as per protocol

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00245453
Other Study ID Numbers  ICMJE HMR3647A6004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE CPL Associates
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Jerome J Schentag, Pharm.D. State University of New York at Buffalo
Study Director: Joseph Paladino, Pharm.D. State University of New York at Buffalo
PRS Account CPL Associates
Verification Date July 2015

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