Bacteremia by EnterobacteriaceaeBACTERIEMIANCT02005159
Study of the Impact of the Minimum Inhibitory Concentration and Susceptible Cut-off Points (CLSI, EUCAST, and Pharmacokinetics/Pharmacodynamics)in Prognosis of Bacteremia by Enterobacteriaceae
An observational study of Bacteremia by Enterobacteriaceae, run by Fundación Pública Andaluza Progreso y Salud at 14 sites in Spain.
Trial summary
Provide scientific and validated data to help International Authorities to set susceptible to antibiotics cut-off points in bacteremia by Enterobacteriaceae Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Bacteremia by Enterobacteriaceae
- What is being tested?
- Microbiological studies
- How many people
- 1,064 participants
- Where
- 14 sitesSpain
- Study dates
- Mar 2011to Dec 2014
- Phase
- Observational
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with bacteremia by Enterobacteriaceae attended in participants Hospitals during the study period
Who may be able to join
- >17 years old
- Clinically significant bacteremia
- Have received treatment fulfilling all this criteria:
- Treated with an only active antibiotic with enterobacteria (association with vancomycin, linezolid, daptomycin, metronidazole or clindamycin) between: cefotaxime, ceftriaxone, ceftazidime, cefepime, amoxicillin/clavulanic, piperacillin/tazobactam, ertapenem, imipenem, meropenem, ciprofloxacin or levofloxacin
- First antibiotic dose was administered during the first 12 hours after the time of sampling
- The antibiotic dosage was at least the advised amount in the summary of product characteristics to patient renal function
- The same antibiotic has been administered during at least 48 hours.
Who cannot join
None listed.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Complejo Hospitalario Universitario A Coruña
A Coruña
Hospital Clínic
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Hospital San Pedro
Logroño
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Son Espases
Palma de Mallorca, Mallorca
Hospital Marqués de Valdecilla
Santander
Hospital Universitario de Valme
Seville
Hospital Universitario Virgen de la Macarena
Seville
Hospital Universitario Virgen del Rocío
Seville
About this study
Official title: Study of the Impact of the Minimum Inhibitory Concentration and Susceptible Cut-off Points (CLSI, EUCAST and Pharmacokinetic/Pharmacodynamic) in Prognosis of Bacteremia by Enterobacteriaceae
Provide scientific and validated data to help International Authorities to set susceptible to antibiotics cut-off points in bacteremia by Enterobacteriaceae
- Conditions
- Bacteremia by Enterobacteriaceae
- Being tested
- Microbiological studies
- Keywords
- Enterobacteria, Bacteremia, Minimum inhibitory concentration, Susceptible, Prognosis
- Medical subject headings
- Bacteremia, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological studiesOther
| Study group | Role | What they receive |
|---|---|---|
| Positive blood-culture to bacteremia by enterobacteria | Patients with positive blood-culture to bacteremia by enterobacteria Receives: Other: Microbiological studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia.
Study the correlation between the minimum inhibitory concentration (MIC) of cefotaxime, ceftriaxone, cefepime, amoxicillin/clavulanic, piperacillin/tazobactam, ertapenem, imipenem, meropenem, ciprofloxacin and levofloxacin and the prognosis in patients with bacteremia by enterobacteria, with or without mechanisms of resistance
Measured: 36 months
Correlation between CLSI and EUCAST cut-off points, FC/FD cut-off points with clinical prognosis and of the microbiological response in patients with bacteremia.
Determine if the CLSI and EUCAST (European Committee on Antimicrobial Susceptibility Testing) sensitive clinical cut-off points, as well as the suggested by pharmacokinetic and pharmacodynamic studies (FC/FD) are properly independent predictors of clinical prognosis and of the microbiological response in patients with bacteremia
Measured: 36 months
Correlation between piperacillin/tazobactam serum concentrations and clinical prognosis
Evaluate if piperacillin/tazobactam serum concentrations are correlated with prognosis based on clinical sensitive cut-off points by CLSI and EUCAST
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteremia by EnterobacteriaceaeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesús Rodríguez-Baño, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005159
- Sponsor's protocol ID
- FPS-ANT-2011-01
- Acronym
- BACTERIEMIA
- Status last verified
- Aug 2015
- First submitted
- 14 Nov 2013
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of the Minimum Inhibitory Concentration and Susceptible Cut-off Points (CLSI, EUCAST and Pharmacokinetic/Pharmacodynamic) in Prognosis of Bacteremia by Enterobacteriaceae
- ClinicalTrials.gov ID
- NCT02005159
- Acronym / sponsor ID
- BACTERIEMIA / FPS-ANT-2011-01
- Conditions
- Bacteremia by Enterobacteriaceae
- Keywords
- Enterobacteria, Bacteremia, Minimum inhibitory concentration, Susceptible, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,064 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Dec 2013 (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.
Provide scientific and validated data to help International Authorities to set susceptible to antibiotics cut-off points in bacteremia by Enterobacteriaceae
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive blood-culture to bacteremia by enterobacteria | – | Other: Microbiological studiesPatients with positive blood-culture to bacteremia by enterobacteria |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with bacteremia by Enterobacteriaceae attended in participants Hospitals during the study period
Key inclusion criteria (7 listed)
- >17 years old
- Clinically significant bacteremia
- Have received treatment fulfilling all this criteria:
Key exclusion criteria (0 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 |
|---|---|---|
| Microbiological studies | Other | Positive blood-culture to bacteremia by enterobacteria |
Primary outcome
Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia.
Time frame: 36 months
Study the correlation between the minimum inhibitory concentration (MIC) of cefotaxime, ceftriaxone, cefepime, amoxicillin/clavulanic, piperacillin/tazobactam, ertapenem, imipenem, meropenem, ciprofloxacin and levofloxacin and the prognosis in patients with bacteremia by enterobacteria, with or without mechanisms of resistance
Correlation between CLSI and EUCAST cut-off points, FC/FD cut-off points with clinical prognosis and of the microbiological response in patients with bacteremia.
Time frame: 36 months
Determine if the CLSI and EUCAST (European Committee on Antimicrobial Susceptibility Testing) sensitive clinical cut-off points, as well as the suggested by pharmacokinetic and pharmacodynamic studies (FC/FD) are properly independent predictors of clinical prognosis and of the microbiological response in patients with bacteremia
Correlation between piperacillin/tazobactam serum concentrations and clinical prognosis
Time frame: 36 months
Evaluate if piperacillin/tazobactam serum concentrations are correlated with prognosis based on clinical sensitive cut-off points by CLSI and EUCAST
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 Aug 2015.
- Related InfoLink provided by the sponsor.
Related trials for Bacteremia by Enterobacteriaceae
RecruitingPhase 4
PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)
Beta Lactam Resistant Bacterial Infection, Enterobacteriaceae Infections
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.
Jesús Rodríguez-Baño principal investigator
Hospital Universitario Virgen Macarena
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia by Enterobacteriaceae, run by Fundación Pública Andaluza Progreso y Salud at 14 sites in Spain.
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 7 inclusion and 0 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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.
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?
Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia. (time frame: 36 months). The study lists 3 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 7 Aug 2015.