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

NCT01710488 | Completed Phase 4 Results DMC

• 1 other identifier: EudraCT N. 2008-003842-27
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 25

Brief 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)

Conditions

COPD Exacerbation

Keywords

COPD exacerbation; fluoroquinolones,

Outcome Measures

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).

  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).

  10 days

Secondary Outcomes (1)

• Percentage of Successful Treatment to Day 7 of Treatment

  7 days

Other Outcomes (4)

• Rehospitalization for COPD Exacerbation During the Follow-up

  one year

• Number of Episodes of Exacerbations

  one year

• Additional Cycles of Antibiotic

  one year

Study Arms (2)

Levofloxacin 1 tablet 500 mg once a day

ACTIVE COMPARATOR

Levofloxacin 1 tablet 500 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients

Drug: Levofloxacin 1 tablet 500 mg once a day

Prulifloxacin 1 tablet 600 mg once a day

EXPERIMENTAL

Prulifloxacin 1 tablet 600 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients

Drug: Prulifloxacin 1 tablet 600 mg once a day

Interventions

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.

Also known as: LEVOXACIN 500 mg

Levofloxacin 1 tablet 500 mg once a day

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.

Also known as: UNIDROX 600 mg

Prulifloxacin 1 tablet 600 mg once a day

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fadoi Foundation, Italy: lead

Study Sites (25)

Hospita "San Francesco Caracciolo"

Agnone, 86081, Italy

Location

Hospital of Alghero

Alghero, 07041, Italy

Location

Hospital "Cardinal Massaia"

Asti, 14100, Italy

Location

Hospital "Fatebenefratelli"

Benevento, 82100, Italy

Location

Hospital of Bordighera

Bordighera, 18012, Italy

Location

Hospital "San Giovanni di Dio"

Cagliari, 09124, Italy

Location

Hospital "Pugliese-Ciaccio"

Catanzaro, 88100, Italy

Location

Hospital "L.Parodi Delfino"

Colleferro, 00034, Italy

Location

Hospita "San Giovanni di Dio"

Crotone, 88900, Italy

Location

Hospital "E.Profili" of Fabriano

Fabriano, 60044, Italy

Location

Hospital "F. Veneziale"

Isernia, 86170, Italy

Location

Hospital Civile Legnano

Legnano, 20025, Italy

Location

Hospital of Ortona

Ortona, 66100, Italy

Location

Hospital Fatebenefratelli "Buccheri La Ferla"

Palermo, 90123, Italy

Location

Hospital "Sant'Anna"

Reggio Emilia, 42035, Italy

Location

Hospital " Santa Maria Nuova"

Reggio Emilia, 42123, Italy

Location

Hospital "Policlinico Universitario Campus Biomedico"

Rome, 00128, Italy

Location

Hospital "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, 71013, Italy

Location

Hospital of Scandiano

Scandiano, 42019, Italy

Location

Hospital "Paolo Dettori"

Tempio Pausania, 0729, Italy

Location

Hospital "Santa Maria" of Terni

Terni, 05100, Italy

Location

Hospital "San Giovanni Bosco"

Torino, 10100, Italy

Location

Hospital "Jazzolino"

Vibo Valentia, 89900, Italy

Location

Hospital "San Bortolo"

Vicenza, 36100, Italy

Location

Hospital "Santa Maria Maddalena"

Volterra, 56048, Italy

Location

Results Point of Contact

• Title: Antonella Valerio
• Organization: Fadoi Foundation

antonella.valerio@fadoi.org

0248005140

Study Officials

• Gualberto GG Gussoni, MD, PhD

  Dept. Clinical Research "Study Centre" - FadoiFoundation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 19, 2012
• Study Start: May 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2012-10

Locations

IT (25)