PneumoniaPhase 3NCT00050401
Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support
A Phase 3 study testing MERREM I.V. 2g as a 3 hour infusion every 8 hours, vancomycin I.V. 1 g every 12 hours and tobramycin I.V. 5 mg/kg every 24 hours in people with Pneumonia, run by Pfizer at 10 sites in United States.
Trial summary
The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- MERREM I.V. 2g as a 3 hour infusion every 8 hours, vancomycin I.V. 1 g every 12 hours and tobramycin I.V. 5 mg/kg every 24 hours
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2002to Sep 2004
- 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
- Onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility
- Diagnosis of hospital-acquired pneumonia requiring mechanical ventilatory support
- Patient or Patient's legal guardian must sign written informed consent for study participation, pretreatment, and Day 7 bronchoscopy
Who cannot join
- Patients with hospital-acquired pneumonia caused by pathogens resistant to MERREM
- Patients with allergies to cephalosporins, penicillins and carbapenems
- Patients taking anticonvulsant therapy for a known seizure disorder
- Patients with lung cancer
- Patients with cystic fibrosis, acquired immune deficiency syndrome (AIDS), neutropenia, active tuberculosis, or patients taking immunosuppressive therapy in preparation for or following an organ transplant.
- Patients who are pregnant or breast feeding
Show all 12Show fewer
- Patients who are unlikely to survive
- Patients with certain infections in another area requiring treatment with additional antibiotics
- Patients with other underlying conditions that would make it difficult to interpret response to study drug.
- Patients who have been part of another clinical study 30 days before entry into this study.
- Patients with hypotension (systolic BP < 85mmHg) or acidosis (arterial pH <7.25 or serum bicarbonate <15 mg/dl) despite attempts at fluid resuscitation
- Patients with profound hypoxia
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Albany, New York
Study site
Boston, Massachusetts
Study site
Cincinnati, Ohio
Study site
Indianapolis, Indiana
Study site
Lebanon, New Hampshire
Study site
New York, New York
Study site
Newark, Delaware
Study site
Phoenix, Arizona
Study site
San Antonio, Texas
Study site
Stony Brook, New York
About this study
Official title: Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-associated Pneumonia
The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
- Conditions
- Pneumonia
- Being tested
- MERREM I.V. 2g as a 3 hour infusion every 8 hours, vancomycin I.V. 1 g every 12 hours, tobramycin I.V. 5 mg/kg every 24 hours, MERREM I.V. 1g as a 30 minute infusion every 8 hours, MERREM I.V. 500 mg as a 3 hour infusion every 8 hours
- Keywords
- ventilator-associated, nosocomial
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MERREM I.V. 2g as a 3 hour infusion every 8 hoursDrug
vancomycin I.V. 1 g every 12 hoursDrug
tobramycin I.V. 5 mg/kg every 24 hoursDrug
MERREM I.V. 1g as a 30 minute infusion every 8 hoursDrug
MERREM I.V. 500 mg as a 3 hour infusion every 8 hoursDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJul 2002
- Primary completionSep 2004
- Study completionSep 2004
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 PfizerThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050401
- Sponsor's protocol ID
- 3591IL/0082
- Status last verified
- Aug 2017
- First submitted
- 8 Dec 2002
- Last updated
- 1 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT00050401
- Acronym / sponsor ID
- 3591IL/0082
- Conditions
- Pneumonia
- Keywords
- ventilator-associated, nosocomial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 10 Dec 2002 (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.
The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility
- Diagnosis of hospital-acquired pneumonia requiring mechanical ventilatory support
- Patient or Patient's legal guardian must sign written informed consent for study participation, pretreatment, and Day 7 bronchoscopy
Key exclusion criteria (12 listed)
- Patients with hospital-acquired pneumonia caused by pathogens resistant to MERREM
- Patients with allergies to cephalosporins, penicillins and carbapenems
- Patients taking anticonvulsant therapy for a known seizure disorder
- Patients with lung cancer
- Patients with cystic fibrosis, acquired immune deficiency syndrome (AIDS), neutropenia, active tuberculosis, or patients taking immunosuppressive therapy in preparation for or following an organ transplant.
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 |
|---|---|---|
| MERREM I.V. 2g as a 3 hour infusion every 8 hours | Drug | – |
| vancomycin I.V. 1 g every 12 hours | Drug | – |
| tobramycin I.V. 5 mg/kg every 24 hours | Drug | – |
| MERREM I.V. 1g as a 30 minute infusion every 8 hours | Drug | – |
| MERREM I.V. 500 mg as a 3 hour infusion every 8 hours | Drug | – |
Primary outcome
Not reported in the source record.
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 1 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MERREM I.V. 2g as a 3 hour infusion every 8 hours, vancomycin I.V. 1 g every 12 hours and tobramycin I.V. 5 mg/kg every 24 hours in people with Pneumonia, run by Pfizer at 10 sites in United States.
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 3 inclusion and 12 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 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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.
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 1 Sep 2017.