SepsisPhase 4CEFPK/PDNCT00609375
Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen
A Phase 4 study testing cefepime in people with Sepsis and Bacteremia, run by Javeriana University at 7 sites in Colombia.
Trial summary
To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Bacteremia
- What is being tested?
- cefepime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesColombia
- Study dates
- Sep 2006to Dec 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sepsis, severe sepsis o septic shock diagnosis hospitalized in Intensive care Unit.
- Presence or suspect of Gram negative bacilli bacteremia
- To be possible the follow up according to planned visits
- Patients should be venous access to administrate the antibiotic
- Patients, whom the physicians consider cefepime like election treatment
Who cannot join
- Patients with a high degree of immunosuppression defined by:
- The presence of neutropenia (Neutrophils count less than 500 cells/mL, or Infection with HIV-AIDS with count of less than 50 CD4 cells/mL, or chronic Administration of immunosuppressive drugs (prednisone more than 5 mg/per day, azathioprine, cyclophosphamide, mycophenolate mofetil, etc.)
- Patients with chronic renal failure.
- Pregnant female patients
- Patients in whom to approach the doctor is considered with a high probability of dying in the next 48 hours (e.g. multiorgan system failure with more than 5 organs engaged according to the criteria of MarshalL et al. or shock irreversible.
- Patients with chronic infections as osteomyelitis or have prosthesis that would perpetuate the infection and requiring the administration of antibiotics for an extended time (including Endocarditis). -Patients with mixed infections that include Gram positive microorganisms or fungal infections.
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- -Patients who have received in the past 30 days cefepime.
- Patients with presence of a gram negative bacillus resistant to cefepime. -Patients who are not able to identify them a bacillus gram negative.
- Patients who they are not able to confirm the antibiotic susceptibility of gram negative bacillus. -Patients with concomitant with antimicrobial activity for Gram negative bacilli (e.g. fluoroquinolones, aminoglycosides, etc.)
- Patients who have known hypersensitivity to B lactams or cefepime
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Colombia7 sites
Clinica Palermo
Bogotá, DC, 6
Fundacion San Carlos
Bogotá, DC, 6
Hospital Santa Clara
Bogotá, DC, 6
Hospital Simon Bolivar
Bogotá, DC, 6
Hospital Universitario san Ignacio
Bogotá, DC, 6
Hospital San Jorge
Pareira, Risaralda Department
Hospital San Juan de Dios
Rionegro, Antioquia
About this study
Official title: Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia
To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days.
Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.
- Conditions
- Sepsis, Bacteremia
- Being tested
- cefepime
- Keywords
- Sepsis, Bacteremia, Intravenous infusions, cefepime
- Medical subject headings
- Sepsis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefepimeDrug
Also called maxipime
Administration of cefepime in continuous infusion (3 Gr over 24 hours) for 7-14 days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours.
cefepimeDrug
Also called Maxipime
Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for 7-14 days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Administration of cefepime in continuous infusion (3 Gr over 24 hours) for at least 7 days and no more than 14 days days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours. Receives: Drug: cefepime |
| II | Active comparator | Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for at least 7 days and no more than 14 days days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours Receives: Drug: cefepime |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate global mortality rate
Measured: 28 days
Secondary outcomes (4)
to evaluate clinical and/or microbiologic relapses
Measured: 28 days
To evaluate clinical and bacteriological response
Measured: 3 days
to evaluate clinical and bacteriological response
Measured: 7 days
to evaluate clinical and bacteriological response
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javeriana University
- Sponsor type
- University, hospital or other
- Collaborators
- Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia, Hospital Simon Bolivar, Bogota, Clinica Palermo, Bogota, Hospital Santa Clara, Bogota, Fundación San Carlos, Bogota, Hospital san Juan de Dios, Antioquia, Hospital san Jorge, Pereira
- Investigators
- carlos A Alvarez, MD, Principal investigator, Pontificia Universidad JaverianaAlvaro Ruiz, MD; MSc, Study chair, Pontificia Universidad JaverianaFabian GIL, Msc, Study chair, Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609375
- Sponsor's protocol ID
- Universidad Javeriana
- Acronym
- CEFPK/PD
- Status last verified
- Jan 2008
- First submitted
- 24 Jan 2008
- Last updated
- 7 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen in Adult Critically Ill Patients With Gram Negative Bacilli Bacteremia
- ClinicalTrials.gov ID
- NCT00609375
- Acronym / sponsor ID
- CEFPK/PD / Universidad Javeriana
- Conditions
- Sepsis, Bacteremia
- Keywords
- Sepsis, Bacteremia, Intravenous infusions, cefepime
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Javeriana UniversityUniversity, hospital or other
- Collaborators
- Asociacion Colombiana de Infectologia, ACIN. Infectious Diseases Society of Colombia, Hospital Simon Bolivar, Bogota, Clinica Palermo, Bogota, Hospital Santa Clara, Bogota, Fundación San Carlos, Bogota, Hospital san Juan de Dios, Antioquia, Hospital san Jorge, Pereira
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Feb 2008 (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.
To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days.
Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: cefepimeAdministration of cefepime in continuous infusion (3 Gr over 24 hours) for at least 7 days and no more than 14 days days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours. |
| II | Active comparator | Drug: cefepimeAdministration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for at least 7 days and no more than 14 days days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with sepsis, severe sepsis o septic shock diagnosis hospitalized in Intensive care Unit.
- Presence or suspect of Gram negative bacilli bacteremia
- To be possible the follow up according to planned visits
- Patients should be venous access to administrate the antibiotic
- Patients, whom the physicians consider cefepime like election treatment
Key exclusion criteria (10 listed)
- Patients with a high degree of immunosuppression defined by:
- Patients with chronic renal failure.
- Pregnant female patients
- Patients in whom to approach the doctor is considered with a high probability of dying in the next 48 hours (e.g. multiorgan system failure with more than 5 organs engaged according to the criteria of MarshalL et al. or shock irreversible.
- Patients with chronic infections as osteomyelitis or have prosthesis that would perpetuate the infection and requiring the administration of antibiotics for an extended time (including Endocarditis). -Patients with mixed infections that include Gram positive microorganisms or fungal infections.
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 |
|---|---|---|
| cefepimeAlso: maxipimeAdministration of cefepime in continuous infusion (3 Gr over 24 hours) for 7-14 days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours. | Drug | I |
| cefepimeAlso: MaxipimeAdministration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for 7-14 days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours | Drug | II |
Primary outcome
To evaluate global mortality rate
Time frame: 28 days
4 secondary outcomes
to evaluate clinical and/or microbiologic relapses
Time frame: 28 days
To evaluate clinical and bacteriological response
Time frame: 3 days
to evaluate clinical and bacteriological response
Time frame: 7 days
to evaluate clinical and bacteriological response
Time frame: 14 days
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 7 Feb 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.
carlos A Alvarez, MD principal investigator
Pontificia Universidad Javeriana
Alvaro Ruiz, MD; MSc study chair
Pontificia Universidad Javeriana
Fabian GIL, Msc study chair
Pontificia Universidad Javeriana
7 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 cefepime in people with Sepsis and Bacteremia, run by Javeriana University at 7 sites in Colombia.
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 5 inclusion and 10 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 7 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Colombia. 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?
To evaluate global mortality rate (time frame: 28 days). 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 7 Feb 2008.