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Outpatient Registry Trial of Respiratory Tract Infections in Adults

This study has been withdrawn prior to enrollment.
(Terminated by sponsor)
Information provided by:
CPL Associates Identifier:
First received: October 26, 2005
Last updated: July 27, 2015
Last verified: July 2015
To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.

Condition Intervention Phase
Pneumonia, Bacterial
Bronchitis, Chronic
Drug: azithromycin
Drug: telithromycin
Drug: Clarythromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)

Resource links provided by NLM:

Further study details as provided by CPL Associates:

Primary Outcome Measures:
  • Time to bacterial eradication [ Time Frame: 11-18 days ]
  • Bacteriologic outcome [ Time Frame: 11-18 days ]

Enrollment: 0
Study Start Date: October 2005
Study Completion Date: July 2006
Arms Assigned Interventions
Active Comparator: 1 Azithromycin Drug: azithromycin
250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5
Active Comparator: 2 Clarythromycin Drug: Clarythromycin
500 mg extended release tablets; 2 tablets QD for 7 days
Active Comparator: 3 Telithromycin Drug: telithromycin
400 mg tablets; 2 tablets once daily (QD) for 5 days

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00245453

United States, Kentucky
Western Kentucky Pulmonary Clinic
Louisville, Kentucky, United States, 42240
United States, Louisiana
Northshore Research Associates
Slidell, Louisiana, United States, 70461
Sponsors and Collaborators
CPL Associates
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
  More Information

Additional Information: Identifier: NCT00245453     History of Changes
Other Study ID Numbers: HMR3647A6004
Study First Received: October 26, 2005
Last Updated: July 27, 2015

Keywords provided by CPL Associates:

Additional relevant MeSH terms:
Respiratory Tract Infections
Bronchitis, Chronic
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on April 28, 2017