NCT00245453

Outpatient Registry Trial of Respiratory Tract Infections in Adults

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CPL Associates · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pneumonia, Bacterial
• Bronchitis, Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-10-01
• Completion: 2006-07-01
• First posted: 2005-10-28
• Last updated: 2015-07-28

Locations

2 sites across 1 country: United States