PneumoniaPhase 3NCT00253955
Study to Demonstrate the Clinical Efficacy of Levofloxacin in the Treatment of Pneumonia
A Phase 3 study testing Levofloxacin and Piperacillin/Tazobactam in people with Pneumonia, run by Sanofi at 17 sites in 17 countries.
Trial summary
Primary Objective: The primary objective of the study is to demonstrate the non-inferiority in clinical efficacy at the test of cure (TOC) visit planned 5-7 days after treatment completion of levofloxacin 750 mg once daily (od) in comparison with piperacillin/tazobactam 4 g/500 mg every 8 hours in treating adult… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Levofloxacin and Piperacillin/Tazobactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 17 sitesin 17 countries
- Study dates
- Jun 2003to Nov 2007
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- General ward or ICU hospitalized subject.
- Subject with diagnosis of hospital-acquired pneumonia of presumed bacterial origin based upon:
- Infection developing after at least 72 hours following hospital admission and
- At least three of the four following signs:
- Fever, defined as body temperature (oral or tympanic temperature ≥ 38°C or rectal temperature ≥ 38.5°C)
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- Purulent tracheal sputum production/secretion or change in sputum character
- Total peripheral white blood cell (WBC) count > 12 G/L or < 4.5 G/L or 15% immature neutrophils (bands), regardless of total peripheral WBC count
- Increased plasma or serum C reactive protein (CRP) level as shown by a level of at least twice the upper boundary of the hospital normal range and
- Chest X-ray findings (anterior posterior [AP] or posterior anterior [PA], if possible lateral view) in agreement with the clinical diagnosis of bacterial pneumonia, i.e. appearance of new, progressive pulmonary infiltrate(s) attributable to infectious etiology.
- Subjects are required to have specimens collected for microbiological documentation within 24 hours prior to enrolment. Specimens should include at least one invasive or noninvasive lower respiratory tract specimen for Gram stain, culture and susceptibility testing, and at least 2 venous blood samples for culture and susceptibility testing.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Related to the hospital-acquired pneumonia (HAP):
- Suspected viral or fungal pneumonia, or HAP strongly suspected to be caused by MRSA (methicillin-resistant Staphylococcus aureus) or organisms responsible for atypical pneumonia, such as Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae
- Patients with severe HAP, defined as presence of at least one of the following:
- In previously non-ventilated patients: need for mechanical ventilation consequently to HAP
- In previously ventilated patients: oxygenation rate defined by partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) < 200
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- Radiographic findings compatible with severe HAP, i.e. showing either:
- Rapid progression (e.g. increase in the size of the opacity by ≥ 50% within 48 hours of the current evaluation)
- OR multilobar pneumonia (> 2 lobes) or involvement of both lungs
- OR cavitation of a lung infiltrate
- Evidence of severe sepsis with hypotension and/or end-organ dysfunction, i.e.:
- Shock commonly evidenced by: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg
- In absence of previous vasopressors use, vasopressors use (except for fluid replacement) for more than 4 hours
- In presence of vasopressors use, increase in vasopressors use (except for fluid replacement) for more than 4 hours
- OR marked reduction in urine output (unless another explanation is available), i.e. in 1 hour: < 20 mL or in 4 hours: < 80 mL
- OR acute renal failure requiring dialysis
- OR profound alteration of mental status, i.e. marked lethargy/stupor/coma
- Related to medical history/concomitant conditions:
- Patients with any concomitant pulmonary diseases, conditions or complications that could confound the interpretation or evaluation of drug efficacy or safety, including severe bronchiectases, cystic fibrosis, active pulmonary tuberculosis or acute pulmonary embolism, empyema, lung abscess or extra pulmonary extension of the LRTI (lower respiratory tract infection), such as meningitis, septic arthritis, endocarditis, known bronchial obstruction due to tumor or foreign body or with a history of post-obstructive pneumonia (this does not exclude patients with COPD [chronic obstructive pulmonary disease]), primary lung cancer or another malignancy metastatic to the lungs, and/or requiring chemotherapeutic treatment (for this or other reasons)
- Patients with any known or suspected bacterial infection other than the disease under investigation which will require concomitant use of a systemic antimicrobial agent other than the study drug allocated
- Patients who have received previous systemic antibiotics longer than 24 hours within 72 hours prior to the enrolment for the same episode of HAP
- Body weight > 95 kg
- Patients with impaired renal function, as shown by creatinine clearance < 20 mL/min
- Hepatic cirrhosis with Child-Pugh score > or = B
- Immuno-compromised patients, such as those presenting with either:
- Known HIV infection with a CD4 + T-lymphocyte count < 0.2 G/L (i.e. < 200 cells/mm3)
- Neutropenia - neutrophil count < 1.0 G/I (i.e. < 1000/mm3)
- Patients on maintenance (≥ 3 months) corticosteroid therapy (> 20 mg/day equivalent prednisolone)
- Related to study drugs:
- Patients with a microbiologically documented infection with a pathogen known prior to inclusion to be resistant to at least one of the study medications
- Patients with known or suspected hypersensitivity to, or known or suspected serious adverse reaction to levofloxacin and/or piperacillin/tazobactam and/or any other quinolones, beta-lactamase inhibitors, penicillins and/or to cephalosporins
- Patients with epilepsy or a history of epilepsy or with predisposition to seizures (e.g. patients with pre-existing central nervous system lesions)
- Patients with known or suspected history of tendon disorders unless a potential relationship to fluoroquinolone administration has been excluded.
- Patients with latent or actual known defects in glucose-6-phosphate dehydrogenase activity
- General:
- Women who are breast-feeding, or are failing to use adequate contraception; for example, systemic hormones (birth control pills, implant), intrauterine device or barrier method (diaphragm with intravaginal spermicide, cervical cap, male or female condom), or are pregnant, as demonstrated by urine or serum pregnancy tests carried out before exposure to study medication or the start of any study procedure that could pose a risk to the foetus
- Patients with a recent (within three months prior to study entry) history of drug or alcohol abuse
- Patients who have received any investigational drug within one month prior to study entry.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
17 sites in 17 countries.
17 sites in 17 countries
About this study
Official title: An Open-Label, Multicenter, Multinational, Centrally Randomized, Two-Arm Parallel-Group Study to Demonstrate the Non-Inferiority in Clinical Efficacy of Levofloxacin 750mg od in Comparison With Piperacillin/Tazobactam 4g/500mg Every 8 Hours in the Treatment of Mild to Moderate Hospital-Acquired Pneumonia Adult Patients in Both General Wards and ICU (Intensive Care Unit)
Primary Objective:
- The primary objective of the study is to demonstrate the non-inferiority in clinical efficacy at the test of cure (TOC) visit planned 5-7 days after treatment completion of levofloxacin 750 mg once daily (od) in comparison with piperacillin/tazobactam 4 g/500 mg every 8 hours in treating adult patients suffering from mild to moderate hospital-acquired pneumonia.
Secondary Objectives:
The secondary objectives of the study are:
- To assess the bacteriological efficacy at the test of cure (TOC) visit
- To assess the clinical and bacteriological efficacy at the end of study (EOS) visit, 28 to 32 days after treatment ends
- To assess the tolerability of both drugs
- Conditions
- Pneumonia
- Being tested
- Levofloxacin, Piperacillin/Tazobactam
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Piperacillin/TazobactamDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Levofloxacin |
| 2 | Active comparator | Not described Receives: Drug: Piperacillin/Tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy data:-Infection related signs and symptoms-Chest X-ray
Measured: from the start to the end of the study
Secondary outcomes (2)
Safety data: Clinical adverse event reporting, including SAE reporting
Measured: From the inform consent signed until the end of the study
Bacteriological efficacy data:-Cultures and susceptibility testing
Measured: from the start to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJun 2003
- Primary completionMay 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gilles Perdriset, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253955
- Sponsor's protocol ID
- HR355_3035
- Status last verified
- Nov 2008
- First submitted
- 14 Nov 2005
- Last updated
- 10 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Multinational, Centrally Randomized, Two-Arm Parallel-Group Study to Demonstrate the Non-Inferiority in Clinical Efficacy of Levofloxacin 750mg od in Comparison With Piperacillin/Tazobactam 4g/500mg Every 8 Hours in the Treatment of Mild to Moderate Hospital-Acquired Pneumonia Adult Patients in Both General Wards and ICU (Intensive Care Unit)
- ClinicalTrials.gov ID
- NCT00253955
- Acronym / sponsor ID
- HR355_3035
- Conditions
- Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- May 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Nov 2005 (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.
Primary Objective:
- The primary objective of the study is to demonstrate the non-inferiority in clinical efficacy at the test of cure (TOC) visit planned 5-7 days after treatment completion of levofloxacin 750 mg once daily (od) in comparison with piperacillin/tazobactam 4 g/500 mg every 8 hours in treating adult patients suffering from mild to moderate hospital-acquired pneumonia.
Secondary Objectives:
The secondary objectives of the study are:
- To assess the bacteriological efficacy at the test of cure (TOC) visit
- To assess the clinical and bacteriological efficacy at the end of study (EOS) visit, 28 to 32 days after treatment ends
- To assess the tolerability of both drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levofloxacin |
| 2 | Active comparator | Drug: Piperacillin/Tazobactam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- General ward or ICU hospitalized subject.
- Subject with diagnosis of hospital-acquired pneumonia of presumed bacterial origin based upon:
- Subjects are required to have specimens collected for microbiological documentation within 24 hours prior to enrolment. Specimens should include at least one invasive or noninvasive lower respiratory tract specimen for Gram stain, culture and susceptibility testing, and at least 2 venous blood samples for culture and susceptibility testing.
Key exclusion criteria (39 listed)
- Suspected viral or fungal pneumonia, or HAP strongly suspected to be caused by MRSA (methicillin-resistant Staphylococcus aureus) or organisms responsible for atypical pneumonia, such as Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae
- Patients with severe HAP, defined as presence of at least one of the following:
- Radiographic findings compatible with severe HAP, i.e. showing either:
- Evidence of severe sepsis with hypotension and/or end-organ dysfunction, i.e.:
- Patients with any concomitant pulmonary diseases, conditions or complications that could confound the interpretation or evaluation of drug efficacy or safety, including severe bronchiectases, cystic fibrosis, active pulmonary tuberculosis or acute pulmonary embolism, empyema, lung abscess or extra pulmonary extension of the LRTI (lower respiratory tract infection), such as meningitis, septic arthritis, endocarditis, known bronchial obstruction due to tumor or foreign body or with a history of post-obstructive pneumonia (this does not exclude patients with COPD [chronic obstructive pulmonary disease]), primary lung cancer or another malignancy metastatic to the lungs, and/or requiring chemotherapeutic treatment (for this or other reasons)
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 |
|---|---|---|
| Levofloxacin | Drug | 1 |
| Piperacillin/Tazobactam | Drug | 2 |
Primary outcome
Clinical efficacy data:-Infection related signs and symptoms-Chest X-ray
Time frame: from the start to the end of the study
2 secondary outcomes
Safety data: Clinical adverse event reporting, including SAE reporting
Time frame: From the inform consent signed until the end of the study
Bacteriological efficacy data:-Cultures and susceptibility testing
Time frame: from the start to the end of the study
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 10 Nov 2008.
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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.
Gilles Perdriset study director
Sanofi
17 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin and Piperacillin/Tazobactam in people with Pneumonia, run by Sanofi at 17 sites in 17 countries.
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 11 inclusion and 39 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 10 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Austria, Belgium, Czechia, France, Germany and 12 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical efficacy data:-Infection related signs and symptoms-Chest X-ray (time frame: from the start to the end of the study). 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 10 Nov 2008.