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NCT Number: NCT01710488

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

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)

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Key information

Conditions

COPD Exacerbation

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospita "San Francesco Caracciolo", Agnone, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Presence of purulent sputum documented by colorimetric assay (Allegra et al., Resp Med 2005), plus at least two of the following signs-symptoms
  • Increased cough
  • Increased dyspnea
  • Increase in sputum volume appeared at least 3 days
  • previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin / clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted for at least 3 days with persistence or worsening of symptoms and subsequent use of hospital
  • ≥ 60 years
  • FEV1 <80% and ≥ 30% and ratio FEV 1 / FVC <70%
  • chest x-ray negative for inflammatory infiltrates
  • informed consent

Exclusion criteria

  • asthma
  • pulmonary neoplasms
  • a history of allergy or hypersensitivity to quinolones
  • impracticability in oral antibiotic and / or altered ability to absorption by the gastrointestinal system
  • a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6 months)
  • history of tendinopathy
  • note or severe renal impairment creatinine> than twice the upper limit of the normal range or hepatic impairment (AST and / or ALT> twice the upper limit of the normal range)
  • patients with sepsis, tuberculosis or other infections in other organs or systems
  • cystic fibrosis
  • patients with inherited tolerance to intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate dehydrogenase
  • pregnant or breastfeeding
  • drug or alcohol addiction
  • experimental concomitant treatment with other drugs

Treatment and study plan

Levofloxacin 1 tablet 500 mg once a day

Drug

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.

Other names: LEVOXACIN 500 mg

Prulifloxacin 1 tablet 600 mg once a day

Drug

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.

Other names: UNIDROX 600 mg

Primary outcomes

  1. 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).

    Time frame: 10 days

    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). The primary study end-point was the percentage of patients with "therapeutic success" (disappearance of all signs/symptoms of disease or reduction of at least 3 points of the total score of symptomatology from baseline) at the conclusion of the cycle of antibiotic therapy (day 10), in the two study groups (levofloxacin and prulifloxacin).

Secondary outcomes

  1. Percentage of Successful Treatment to Day 7 of Treatment

    Time frame: 7 days

Other outcomes

  1. Rehospitalization for COPD Exacerbation During the Follow-up

    Time frame: one year

  2. Number of Episodes of Exacerbations

    Time frame: one year

  3. Additional Cycles of Antibiotic

    Time frame: one year

  4. Survival

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Fadoi Foundation, Italy

Other

Registry information

Official study title

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

Acronym: FLOR

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2012
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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