Outpatient Registry Trial of Respiratory Tract Infections in Adults

Pneumonia, Bacterial Clinical Trial

Official title:

Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00245453
• Other study ID #: HMR3647A6004
• Status: Withdrawn
• Phase: Phase 4
• First received: October 26, 2005
• Last updated: July 27, 2015
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: July 2015
• Source: CPL Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Pneumonia
• Pneumonia, Bacterial
• Respiratory Tract Infections

Intervention

Drug:
• azithromycin
250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5
• telithromycin
400 mg tablets; 2 tablets once daily (QD) for 5 days
• Clarythromycin
500 mg extended release tablets; 2 tablets QD for 7 days

Locations

Country	Name	City	State
United States	Western Kentucky Pulmonary Clinic	Louisville	Kentucky
United States	Northshore Research Associates	Slidell	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
CPL Associates	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to bacterial eradication		11-18 days
Primary	Bacteriologic outcome		11-18 days

External Links

•   Link