SepsisPhase 4NCT00318552
Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
A Phase 4 study testing Meropenem in people with Sepsis, run by Pfizer at 12 sites in Hungary.
Trial summary
This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Meropenem
- How many people
- 160 participants
- Where
- 12 sitesHungary
- Study dates
- Jan 2002to Jun 2006
- 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
- Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.
Who cannot join
- -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Hungary12 sites
Research Site
Baja
Research Site
Budapest
Research Site
Eger
Research Site
Kecskemét
Research Site
Kistarcsa
Research Site
Miskolc
Research Site
Pécs
Research Site
Siófok
Research Site
Székesfehérvár
Research Site
Szolnok
Research Site
Szombathely
Research Site
Veszprém
About this study
Official title: Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study.
This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.
- Conditions
- Sepsis
- Being tested
- Meropenem
- Keywords
- Antibiotic Therapy, sepsis treatment, Meropenem
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days from randomization to recovery from sepsis among those patients who survived the trial period
Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis
Secondary outcomes (9)
Number of days from randomization to ready to discharge from the ICU
Number of days from randomization until patient is discharged from the ICU
Number of days on first line antibiotic therapy
Number of days from randomization until patient is discharged from hospital
Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy
Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy
Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group
Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group
Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startJan 2002
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318552
- Sponsor's protocol ID
- 3591/9014
- Other IDs
- D9211C09014
- Status last verified
- Aug 2017
- First submitted
- 25 Apr 2006
- 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
- Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study.
- ClinicalTrials.gov ID
- NCT00318552
- Acronym / sponsor ID
- 3591/9014
- Conditions
- Sepsis
- Keywords
- Antibiotic Therapy, sepsis treatment, Meropenem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 27 Apr 2006 (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.
This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.
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 (1 listed)
- Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Meropenem | Drug | – |
Primary outcome
Number of days from randomization to recovery from sepsis among those patients who survived the trial period
Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis
9 secondary outcomes
Number of days from randomization to ready to discharge from the ICU
Number of days from randomization until patient is discharged from the ICU
Number of days on first line antibiotic therapy
Number of days from randomization until patient is discharged from hospital
Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy
Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy
Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group
Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group
Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials
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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD study director
AstraZeneca
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropenem in people with Sepsis, run by Pfizer at 12 sites in Hungary.
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 1 inclusion and 1 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 12 sites in Hungary. 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?
Number of days from randomization to recovery from sepsis among those patients who survived the trial period. The study lists 2 primary outcomes in all. 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 1 Sep 2017.