NCT01710488

Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD

A Randomized, Controlled, Single-blind, Parallel-group Comparison Between Levofloxacin and Prulifloxacin, in Patients With Acute Exacerbation of COPD Unresponsive to Other Antibiotics and Admitted to the Internal Medicine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Fadoi Foundation, Italy · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine the percentage of patients with "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)

Detailed description

The aim of this study was to examine the effects of the use of fluoroquinolones a class of antibiotics introduced relatively recently, in a particular population of patients with acute exacerbation of COPD, previously treated unsuccessfully with other antibiotics, and hospitalized in Internal Medicine. These patients reflect the reality of patients admitted to Internal Medicine, they are characterized by a high frequency of advanced age, polypathology, with multiple treatments.

Conditions

• COPD Exacerbation

Interventions

Type	Name	Description
DRUG	Levofloxacin 1 tablet 500 mg once a day	Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients: Levofloxacin 500 mg (1 tablet) once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.
DRUG	Prulifloxacin 1 tablet 600 mg once a day	Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients: Prulifloxacin 1 tablet 600 mg once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-10-19
• Last updated: 2025-02-11
• Results posted: 2025-02-11

Locations

25 sites across 1 country: Italy