COPD ExacerbationPhase 4NCT01467297
Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB)
A Phase 4 study testing ceftidoren and levofloxacin in people with COPD Exacerbation, run by University of Milan at 1 site in Italy.
Trial summary
40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- ceftidoren and levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients with age between 40 and 75 years with no limitation of race.
- Patients with a diagnosis of Acute Exacerbations of Chronic Bronchitis* characterized by the presence of the following three symptoms, or at least two including purulence:
- increased dyspnoea;
- increased of sputum volume;
- increased of sputum purulence, that had to be confirmed macroscopically by the investigator.
- Chronic bronchitis is characterized by cough and excessive secretion of mucus and is diagnosed when patients report production of sputum on most days over at least three consecutive months for 2 or more consecutive years (American Thoracic Society 1995).
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- FEV1 >50% of the predicted value.
- Availability of a valid sputum specimen of broncho-pulmonary origin for microbiological evaluation obtained by either expectoration, suction, bronchoscopy or bronchial lavage. Valid samples will be characterized by < 10 squamous epithelial cells and > 25 polymorph nuclear leucocytes per low-power magnification 100x field (Wilson 2004).
- Negative chest radiography to rule out pneumonia and active tuberculosis.
- Written informed consent to the trial signed and dated by the patient according to the local regulations, obtained prior to all activities related to the trial.
Who cannot join
- Hypersensitivity or allergy to antibacterial betalactams or fluoroquinolones and/or to any component of the study medications.
- Underlying asthma.
- Systemic corticosteroids (treatment since ≤ 2 weeks before trial drug administration) are excluded, unless patients are chronically treated (treatment for >2 weeks before trial drug administration). Corticosteroid nasal spray administration is allowed in the first 3 days of the study drug administrations only.
- Childbearing potential where pregnancy is not excluded by pregnancy test in urine (HCG), or lactation.
- History of tendinopathy.
- Recent or past history of psychiatric illness or epilepsy.
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- Recent or past history of cardiac disease or rhythm disorders or clinically significant ECG abnormalities.
- Latent or known deficiencies for the glucose-6-phosphate dehydrogenase activity.
- Known severe hepatic and/or renal insufficiency (AST, ALT and/or creatinine levels more than twice as high as the Upper Laboratory Norm, ULN). Should laboratory data not be available when treatment is required, the patient may be conditionally enrolled.
- Other lower respiratory tract illness: severe bronchiectasis, cystic fibrosis, or pulmonary malignancy.
- Concurrent infections and /or neoplasm.
- Concomitant treatment with hypoglycemic drugs.
- Patients under treatment with fenbufen and xanthines. Patients treated with xanthines could however be recruited if plasma levels were monitored; if plasma levels exceeded concentrations of 10-15 micrograms/ml, the daily dosages of xanthines should be lowered by the Investigator (Hendels 1983);
- Treatment with antibiotics or antibacterials within the previous week
- Treatment with experimental drugs in the previous 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB). Multi-centre, Open-label, Randomised, Pilot Study to Evaluate the Effects of the Treatment on Serum Inflammatory Biomarkers
40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days. Primary objective of the study is to evaluate the effects of the treatment on serum inflammatory biomarkers and the secondary objective is to evaluate the clinical and microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment).
The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4); Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy assessment, Day 28-30).
The primary parameter to test the efficacy of the study medications will be the assessment of the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of 10% will be taken into account. The comparison between treatments will be performed at visit 2 and 3.
- Conditions
- COPD Exacerbation
- Being tested
- ceftidoren, levofloxacin
- Keywords
- Chronic bronchitis, exacerbations, treatment, ceftidoren, levofloxacin, inflammation
- Medical subject headings
- Bronchitis, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftidorenDrug
Also called Giasion, J01D
ceftidoren 200 mg bid for 5 days
levofloxacinDrug
Also called levoxacin, J01M
levofloxacin 500 mg once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| ceftidoren | Experimental | ceftidoren 200 mg bid for 5 days Receives: Drug: ceftidoren |
| levofloxacin | Active comparator | levofloxacin 500 mg once daily for 7 days Receives: Drug: levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum inflammatory biomarkers
assessment of the speed of reduction of inflammatory parameters (C-reactive protein(CRP), procalcitonin( PCT) and mucin-like glycoprotein(KL6)). Every reduction of 10% will be taken into account.
Measured: change from baseline at day 2-4 and day 7-10
Secondary outcomes (2)
clinical efficacy
Clinical assessment (Vist 2 and visit 3) of signs and symptoms of acute exacerbations of Chronic bronchitis(AECB), such as sputum purulence, sputum volume, dyspnoea, cough and body temperature using a clinical score.The total scores obtained at Visit 2 and Visit 3 test of cure (TOC) will be compared with those obtained at Visit 1.
Measured: change from baseline to day 2-4 and day 7-10
Microbiology efficacy
Microbiological assessments will be performed on valid sputum specimens At the TOC Visit, 7-10 days after the end of treatment.
The results obtained at Visit 2 and Visit 3 test of cure(TOC) will be compared with those obtained at Visit 1
Measured: change from baseline to day 2-4 and day 7-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Blasi, University of Milan
- Investigators
- Francesco B Blasi, MD, Study chair, University of Milan Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467297
- Sponsor's protocol ID
- SP1
- Other IDs
- 2011-000531-88
- Status last verified
- Jun 2012
- First submitted
- 16 Sep 2011
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB). Multi-centre, Open-label, Randomised, Pilot Study to Evaluate the Effects of the Treatment on Serum Inflammatory Biomarkers
- ClinicalTrials.gov ID
- NCT01467297
- Acronym / sponsor ID
- SP1
- Conditions
- COPD Exacerbation
- Keywords
- Chronic bronchitis, exacerbations, treatment, ceftidoren, levofloxacin, inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days. Primary objective of the study is to evaluate the effects of the treatment on serum inflammatory biomarkers and the secondary objective is to evaluate the clinical and microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment).
The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4); Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy assessment, Day 28-30).
The primary parameter to test the efficacy of the study medications will be the assessment of the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of 10% will be taken into account. The comparison between treatments will be performed at visit 2 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ceftidoren | Experimental | Drug: ceftidorenceftidoren 200 mg bid for 5 days |
| levofloxacin | Active comparator | Drug: levofloxacinlevofloxacin 500 mg once daily for 7 days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female outpatients with age between 40 and 75 years with no limitation of race.
- Patients with a diagnosis of Acute Exacerbations of Chronic Bronchitis* characterized by the presence of the following three symptoms, or at least two including purulence:
- FEV1 >50% of the predicted value.
- Availability of a valid sputum specimen of broncho-pulmonary origin for microbiological evaluation obtained by either expectoration, suction, bronchoscopy or bronchial lavage. Valid samples will be characterized by < 10 squamous epithelial cells and > 25 polymorph nuclear leucocytes per low-power magnification 100x field (Wilson 2004).
- Negative chest radiography to rule out pneumonia and active tuberculosis.
Key exclusion criteria (15 listed)
- Hypersensitivity or allergy to antibacterial betalactams or fluoroquinolones and/or to any component of the study medications.
- Underlying asthma.
- Systemic corticosteroids (treatment since ≤ 2 weeks before trial drug administration) are excluded, unless patients are chronically treated (treatment for >2 weeks before trial drug administration). Corticosteroid nasal spray administration is allowed in the first 3 days of the study drug administrations only.
- Childbearing potential where pregnancy is not excluded by pregnancy test in urine (HCG), or lactation.
- History of tendinopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftidorenAlso: Giasion, J01Dceftidoren 200 mg bid for 5 days | Drug | ceftidoren |
| levofloxacinAlso: levoxacin, J01Mlevofloxacin 500 mg once daily for 7 days | Drug | levofloxacin |
Primary outcome
serum inflammatory biomarkers
Time frame: change from baseline at day 2-4 and day 7-10
assessment of the speed of reduction of inflammatory parameters (C-reactive protein(CRP), procalcitonin( PCT) and mucin-like glycoprotein(KL6)). Every reduction of 10% will be taken into account.
2 secondary outcomes
clinical efficacy
Time frame: change from baseline to day 2-4 and day 7-10
Microbiology efficacy
Time frame: change from baseline to day 2-4 and day 7-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco B Blasi, MD study chair
University of Milan Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ceftidoren and levofloxacin in people with COPD Exacerbation, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum inflammatory biomarkers (time frame: change from baseline at day 2-4 and day 7-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.