InfectionPhase 4NCT00445094
A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)
A Phase 4 study testing MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days, Comparator: amikacin / Duration of Treatment: 3 Days and Comparator: tazocin / Duration of Treatment: 3 Days in people with Infection and Pneumonia, run by Merck Sharp & Dohme LLC.
Trial summary
The primary objective of this study is a comparison between MK0787B and standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days, Comparator: amikacin / Duration of Treatment: 3 Days and Comparator: tazocin / Duration of Treatment: 3 Days
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jan 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age
- Patient is diagnosed with nosocomial pneumonia
Who cannot join
- Immunological deficient patients
- Pregnant women and nursing mothers
- A fungus is identified before the study enrollment
- Received vancomycin or imipenem for more than 5 days before icu admission
About this study
Official title: A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit
The primary objective of this study is a comparison between MK0787B and standard therapy.
- Being tested
- MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days, Comparator: amikacin / Duration of Treatment: 3 Days, Comparator: tazocin / Duration of Treatment: 3 Days, Comparator: vancomycin / Duration of Treatment: 3 Days
- Medical subject headings
- Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 DaysDrug
Comparator: amikacin / Duration of Treatment: 3 DaysDrug
Comparator: tazocin / Duration of Treatment: 3 DaysDrug
Comparator: vancomycin / Duration of Treatment: 3 DaysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startNov 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445094
- Sponsor's protocol ID
- 0787B-092
- Other IDs
- 2007_004
- Status last verified
- Feb 2017
- First submitted
- 6 Mar 2007
- Last updated
- 17 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00445094
- Acronym / sponsor ID
- 0787B-092
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 8 Mar 2007 (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 primary objective of this study is a comparison between MK0787B and standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- 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 (2 listed)
- Greater than 18 years of age
- Patient is diagnosed with nosocomial pneumonia
Key exclusion criteria (4 listed)
- Immunological deficient patients
- Pregnant women and nursing mothers
- A fungus is identified before the study enrollment
- Received vancomycin or imipenem for more than 5 days before icu admission
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 |
|---|---|---|
| MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days | Drug | – |
| Comparator: amikacin / Duration of Treatment: 3 Days | Drug | – |
| Comparator: tazocin / Duration of Treatment: 3 Days | Drug | – |
| Comparator: vancomycin / Duration of Treatment: 3 Days | Drug | – |
Primary outcome
A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score
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 17 Feb 2017.
- Click here to access a synopsis of the study results.Link provided by the sponsor.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days, Comparator: amikacin / Duration of Treatment: 3 Days and Comparator: tazocin / Duration of Treatment: 3 Days in people with Infection and Pneumonia, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 4 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score. 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 17 Feb 2017.