Outpatient Registry Trial of Respiratory Tract Infections in Adults
This study has been terminated.
(Terminated by sponsor)
Sponsor:
CPL Associates
Collaborator:
Sanofi
Information provided by:
CPL Associates
ClinicalTrials.gov Identifier:
NCT00245453
First received: October 26, 2005
Last updated: October 30, 2007
Last verified: October 2007
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Purpose
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 Endpoint Classification: Pharmacokinetics/Dynamics Study 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:
Drug Information available for:
Clarithromycin
Azithromycin
Azithromycin dihydrate
Azithromycin monohydrate
Telithromycin
U.S. FDA Resources
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
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245453
Locations
| 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
Sanofi
Investigators
| 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:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00245453 History of Changes |
| Other Study ID Numbers: | HMR3647A6004 |
| Study First Received: | October 26, 2005 |
| Last Updated: | October 30, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CPL Associates:
|
pneumonia Spneumoniae bronchitis telithromycin azithromycin |
Additional relevant MeSH terms:
|
Pneumonia, Bacterial Bronchitis Bronchitis, Chronic Pneumonia Respiratory Tract Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Bronchial Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive |
Infection Azithromycin Clarithromycin Telithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013