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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Successful Treatment to Day 7 of Treatment | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalization for COPD Exacerbation During the Follow-up | one year | |
| Number of Episodes of Exacerbations | one year | |
| Additional Cycles of Antibiotic |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gualberto GG Gussoni, MD, PhD | Dept. Clinical Research "Study Centre" - FadoiFoundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospita "San Francesco Caracciolo" | Agnone | 86081 | Italy | |||
| Hospital of Alghero |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levofloxacin 1 Tablet 500 mg Once a Day | 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 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. |
|
|
| one year |
| Survival | one year |
| Alghero |
| 07041 |
| Italy |
| Hospital "Cardinal Massaia" | Asti | 14100 | Italy |
| Hospital "Fatebenefratelli" | Benevento | 82100 | Italy |
| Hospital of Bordighera | Bordighera | 18012 | Italy |
| Hospital "San Giovanni di Dio" | Cagliari | 09124 | Italy |
| Hospital "Pugliese-Ciaccio" | Catanzaro | 88100 | Italy |
| Hospital "L.Parodi Delfino" | Colleferro | 00034 | Italy |
| Hospita "San Giovanni di Dio" | Crotone | 88900 | Italy |
| Hospital "E.Profili" of Fabriano | Fabriano | 60044 | Italy |
| Hospital "F. Veneziale" | Isernia | 86170 | Italy |
| Hospital Civile Legnano | Legnano | 20025 | Italy |
| Hospital of Ortona | Ortona | 66100 | Italy |
| Hospital Fatebenefratelli "Buccheri La Ferla" | Palermo | 90123 | Italy |
| Hospital "Sant'Anna" | Reggio Emilia | 42035 | Italy |
| Hospital " Santa Maria Nuova" | Reggio Emilia | 42123 | Italy |
| Hospital "Policlinico Universitario Campus Biomedico" | Rome | 00128 | Italy |
| Hospital "Casa Sollievo della Sofferenza" | San Giovanni Rotondo | 71013 | Italy |
| Hospital of Scandiano | Scandiano | 42019 | Italy |
| Hospital "Paolo Dettori" | Tempio Pausania | 0729 | Italy |
| Hospital "Santa Maria" of Terni | Terni | 05100 | Italy |
| Hospital "San Giovanni Bosco" | Torino | 10100 | Italy |
| Hospital "Jazzolino" | Vibo Valentia | 89900 | Italy |
| Hospital "San Bortolo" | Vicenza | 36100 | Italy |
| Hospital "Santa Maria Maddalena" | Volterra | 56048 | Italy |
| FG001 | Prulifloxacin 1 Tablet 600 mg Once a Day | 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 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Levofloxacin 1 Tablet 500 mg Once a Day | 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 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. |
| BG001 | Prulifloxacin 1 Tablet 600 mg Once a Day | 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 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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). | The analyses concerning the primary study end-point were carried out both on the "intention-to-treat" and "per-protocol" populations, more than 90% of patients had a therapeutic success at the end of treatment cycle in both study groups. Here is reported the ITT population | Posted | Count of Participants | Participants | 10 days |
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| |||||||||||||||||||||||||||||
| Secondary | Percentage of Successful Treatment to Day 7 of Treatment | Not Posted | 7 days | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Rehospitalization for COPD Exacerbation During the Follow-up | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Episodes of Exacerbations | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Additional Cycles of Antibiotic | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Survival | Not Posted | one year | Participants |
Total time frame for adeverse drug reaction: 10 days or 7 days + 1 month Total time frame for survival: 10 days or 7 days + 1 year
Adverse event and/or serious adverse event, used to collect adverse event information, not differs from the clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levofloxacin 1 Tablet 500 mg Once a Day | 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 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. | 11 | 128 | 2 | 128 | 1 | 128 |
| EG001 | Prulifloxacin 1 Tablet 600 mg Once a Day | 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 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. | 5 | 130 | 1 | 130 | 5 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Psychomotor agitation | Nervous system disorders | Systematic Assessment |
| ||
| muscular pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Epigastric pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute enteritis | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonella Valerio | Fadoi Foundation | 0248005140 | antonella.valerio@fadoi.org |
| Between 18 and 65 years |
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| >=65 years |
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