Phase 4
N=258
Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD
COPD Exacerbation
Bottom Line
View on ClinicalTrials.gov: NCT01710488 ↗Enrolled (actual)
258
Serious AEs
1.2%
Results posted
Feb 2025
Primary outcome: Primary: 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). — 119; 126 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levofloxacin 1 tablet 500 mg once a day (Drug); Prulifloxacin 1 tablet 600 mg once a day (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Fadoi Foundation, Italy
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
119; 126 | — |
| SECONDARY Percentage of Successful Treatment to Day 7 of Treatment |
— | — |
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)
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01710488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.