Clinically Significant BacteremiaINCREMENTNCT01764490

Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to Extended-spectrum Beta-lactamase (ESBL) or Carbapenemase-producing Enterobacteriaceae: an Observational Multinational Study

An observational study of Clinically Significant Bacteremia, run by JESUS RODRIGUEZ BAÑO at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Main objective: to observationally assess the efficacy of different antimicrobials in Bloodstream Infection (BSI) due to Enterobacteriaceae producing ESBLs or carbapenemases. Specific objectives: Bacteraemic infections due to ESBL-producing Enterobacteriaceae: To demonstrate that β-lactam/β-lactam inhibitors are not… Read more about this study

Who is it for?: Any age
Conditions the study is for: Clinically Significant Bacteremia
How many people: 1,344 participants
Where: 1 siteSpain
Study dates: Jan 2013to May 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: - Episode of clinically-significant monomicrobial BSI due to ESBL or carbapenemase-producing Enterobacteriaceae, including community and nosocomial ones

Who may be able to join

Episode of clinically-significant monomicrobial BSI due to ESBL or carbapenemase-producing Enterobacteriaceae, including community and nosocomial ones.
For ESBL-producers, detection by standard phenotypic method as recommended by CLSI is enough (although PCR-based characterisation is preferred, see below).
For carbapenemase-producers, characterisation by at least PCR is necessary (isolates in which carbapenemase production is suspected based on antimicrobial susceptibility profile plus phenotypic tests alone is not acceptable, see below).
Subsequent episodes in a patient caused by the same microorganism may be included if the interval between them is >3 months.
No age limits.

Who cannot join

Polymicrobial or non-clinically significant episodes. Episodes in which a potential contaminant (e.g., coagulase-negative staphylococci) is isolated only in one set of blood cultures and there is not a typical source of infection for that kind of organism (e.g. catheter-related) may be included.
Unavailability of key data (such cases should be counted to analyse a potential selection bias)
Episode occurring before January 2004.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Virgen Macarena University Hospital
Seville, Andalusia, 41009

Other trials in Spain

About this study

Official title: Impact of Specific Antimicrobials and Minimal Inhibitory Concentration(MIC) Values on the Outcome of Bloodstream Infections Due to ESBL or Carbapenemase-producing Enterobacteriaceae: an Observational Multinational Study

Main objective: to observationally assess the efficacy of different antimicrobials in Bloodstream Infection (BSI) due to Enterobacteriaceae producing ESBLs or carbapenemases.

Specific objectives:

Bacteraemic infections due to ESBL-producing Enterobacteriaceae:

To demonstrate that β-lactam/β-lactam inhibitors are not associated with worse cure rate and mortality than carbapenems after controlling for confounders, both as empirical and definitive therapy.
To demonstrate that fluoroquinolones as definitive therapy are not associated with worse cure rate and mortality than carbapenems after controlling for confounders.
To demonstrate that empirical cephalosporins in monotherapy are associated with worse cure rate and mortality than carbapenems after controlling for confounders in infections others than urinary tract infections.
To demonstrate that the association of active aminoglycosides with cephalosporins or fluoroquinolines is not associated with worse cure rate and mortality than carbapenems after controlling for confounders.
To demonstrate that combination empirical and definitive therapy is not associated with better cure rate than monotherapy after controlling for confounders.
For tigecycline, colistin, and fosfomycin, no hypothesis. The objective is to provide adjusted estimations of their association with outcome variables in comparison with carbapenem monotherapy according to clinical situation and infection.

Bacteraemic infections due to carbapenemase-producing Enterobacteriaceae:

To demonstrate that combination therapy is associated with worse cure rate and mortality than monotherapy after controlling for confounders.
To show that carbapenems are associated with worse cure rate and mortality when used in infections other than urinary tract caused by isolates showing MIC <2 µg/mL for imipenem or meropenem in comparison to those caused by isolates with higher MIC, after controlling for confounders.
To show that colistin used at a dose >6 million IU per day is associated with improved outcomes in comparison with lower dose, after controlling for confounders.

Read the detailed description

METHODS

Study design: multicentre, international retrospective cohort study.

Sites: multiple expert investigators from different countries are invited.

Conditions to fulfil to participate include availability of a database with the required data or ability to retrospectively collect the data in a timely manner.

Procedure

The participant centres are asked to include:

Previously published cases: all these cases should be included if possible. The fact that the case had been previously published should be specified in the database.
Additionally, participants are asked to include consecutive episodes detected by reviewing their databases (clinical, infection control or microbiological records) from January 2004 to June 2012, according to the following criteria:
For ESBL producers:

A minimum of 20 and a maximum of 50 cases should be included from each centre (the more recent ones should be selected).

Cases for which the enzyme is characterised at least to group level by polymerase chain reaction, PCR, (it is, CTX-M, SHV, TEM) should be prioritised despite the date of diagnosis.
If not enough number of cases with PCR-characterized enzymes are available, or PCR-characterisation has not been performed, the total number of cases should be completed by including cases in which ESBL-production was identified using a standard phenotypic method.
For carbapenemase-producers: only cases in which the carbapenemase was characterised by PCR should be included. All episodes up to a limit of 50 cases per centre may be included.

Overall, to avoid selection biases, consecutive cases according to previous criteria should be included.

Variables

A common online database has been designed. Individual access to the database will be provided.

Main outcome variable: Cure rate at day 14

Secondary outcome variables: Mortality at 72 hours, 7, 14 and 30 days, clinical improvement at 72 hours, clinical cure at day 28.

Explanatory variables:

Demographics
Severity of chronic underlying conditions: McCabe and Charlson index
Acute severity of underlying disease: Pitt score during the the day before BSI.
Type of acquisition
Source of BSI
Severity of SIRS at presentation
Microorganism, betalactamase, MICs
Empirical therapy
Definitive therapy

Quality of data. Data will be approved and signed by the responsible investigator in each center. All data will be centrally reviewed; queries will be sent for lacking data and those showing inconsistencies or discrepancies. Data will be analysed per center; those with data showing significant differences with the average will be requested for review.

Statistical Analysis Plan

Subcohorts with patients treated with the treatment to be compared will be selected.
A propensity score to receive the 2 treatment types to compare will be calculated by obtaining a non-parsimonious multivariate model by logistic regression in which the outcome variable will be the treatment type. The explanatory variables will include age, gender, center, type of ward, acquisition, Charlson index, Pitt score, severity of SIRS and source.
After univariate analysis, multivariate analysis to investigate the adjusted association of treatment type with the main and secondary outcome variables will be performed by using logistic regression (for clinical response at day 14) and by Cox regression for mortality. If time until death is unavailable, logistic regression will be used for 30-day mortality. Logistic regression will also be used for 72-hour and 30-day clinical response. The propensity score will be added in all cases; also, Charlson score, Pitt score, severity of SIRS and source will be added. Finally, interaction between treatment type and source classified as urinary tract and others will be included.

Conditions: Clinically Significant Bacteremia
Keywords: Bloodstream infections caused by multidrug-resistant Enterobacteriaceae, extended-spectrum β-lactamase-producers, carbapenemase-producing organisms

What is being measured

The primary outcome is the main question the study is designed to answer.

Cure rate at day 14
- Cure: resolution of all signs and symptoms related to the infection, and antibiotic therapy is no longer necessary
Measured: within the first 14 days after treatment started

Secondary outcomes (6)

Mortality at 72 hours
Dead: death of the patient for whatever the reason.
Measured: within the first 72 hours
Mortality at 7 days
Dead: death of the patient for whatever the reason.
Measured: within 7 days after treatment started
Mortality at 14 days
Dead: death of the patient for whatever the reason.
Measured: within 14 days after treatment started
Mortality at 30 days
Dead: death of the patient for whatever the reason.
Measured: within 30 days after treatment started
Clinical Improvement at 72 hours
Improvement: partial control or resolution of signs and symptoms related to the infection, or resolution but antibiotic therapy is still necessary.
Non-improvement or deterioration: clinical situation qualified as similar or worse in comparison to that at the diagnosis of bacteremia.
Measured: within the first 72 hours after treatment started
Clinical cure at 28 days
Clinical Cure: resolution of all signs and symptoms related to the infection, and antibiotic therapy is no longer necessary.
Measured: within 28 days after treatment started

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013May 2014

First posted9 Jan 2013 (estimated)
Study startJan 2013
Primary completionDec 2013
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Clinically Significant BacteremiaStudies 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: Retrospective
Enrolment: 1,344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01764490
Sponsor's protocol ID: REIPI-1WP701
Other IDs: JRB-ANT-2012-01
Acronym: INCREMENT
Status last verified: Jun 2014
First submitted: 26 Dec 2012
Last updated: 27 Jun 2014
Results posted: No
Data monitoring committee: Yes

Publications

Scheuerman O, Schechner V, Carmeli Y, Gutierrez-Gutierrez B, Calbo E, Almirante B, Viale PL, Oliver A, Ruiz-Garbajosa P, Gasch O, Gozalo M, Pitout J, Akova M, Pena C, Molina J, Hernandez-Torres A, Venditti M, Prim N, Origuen J, Bou G, Tacconelli E, Tumbarello M, Hamprecht A, Karaiskos I, de la Calle C, Perez F, Schwaber MJ, Bermejo J, Lowman W, Hsueh PR, Navarro-San Francisco C, Bonomo RA, Paterson DL, Pascual A, Rodriguez-Bano J; REIPI/ESGBIS/INCREMENT investigators. Comparison of Predictors and Mortality Between Bloodstream Infections Caused by ESBL-Producing Escherichia coli and ESBL-Producing Klebsiella pneumoniae. Infect Control Hosp Epidemiol. 2018 Jun;39(6):660-667. doi: 10.1017/ice.2018.63. Epub 2018 Apr 5.
PubMed 29618394
Gutierrez-Gutierrez B, Salamanca E, de Cueto M, Hsueh PR, Viale P, Pano-Pardo JR, Venditti M, Tumbarello M, Daikos G, Canton R, Doi Y, Tuon FF, Karaiskos I, Perez-Nadales E, Schwaber MJ, Azap OK, Souli M, Roilides E, Pournaras S, Akova M, Perez F, Bermejo J, Oliver A, Almela M, Lowman W, Almirante B, Bonomo RA, Carmeli Y, Paterson DL, Pascual A, Rodriguez-Bano J; REIPI/ESGBIS/INCREMENT Investigators. Effect of appropriate combination therapy on mortality of patients with bloodstream infections due to carbapenemase-producing Enterobacteriaceae (INCREMENT): a retrospective cohort study. Lancet Infect Dis. 2017 Jul;17(7):726-734. doi: 10.1016/S1473-3099(17)30228-1. Epub 2017 Apr 22.
PubMed 28442293
Gutierrez-Gutierrez B, Perez-Galera S, Salamanca E, de Cueto M, Calbo E, Almirante B, Viale P, Oliver A, Pintado V, Gasch O, Martinez-Martinez L, Pitout J, Akova M, Pena C, Molina J, Hernandez A, Venditti M, Prim N, Origuen J, Bou G, Tacconelli E, Tumbarello M, Hamprecht A, Giamarellou H, Almela M, Perez F, Schwaber MJ, Bermejo J, Lowman W, Hsueh PR, Mora-Rillo M, Natera C, Souli M, Bonomo RA, Carmeli Y, Paterson DL, Pascual A, Rodriguez-Bano J. A Multinational, Preregistered Cohort Study of beta-Lactam/beta-Lactamase Inhibitor Combinations for Treatment of Bloodstream Infections Due to Extended-Spectrum-beta-Lactamase-Producing Enterobacteriaceae. Antimicrob Agents Chemother. 2016 Jun 20;60(7):4159-69. doi: 10.1128/AAC.00365-16. Print 2016 Jul.
PubMed 27139473
Gutierrez-Gutierrez B, Bonomo RA, Carmeli Y, Paterson DL, Almirante B, Martinez-Martinez L, Oliver A, Calbo E, Pena C, Akova M, Pitout J, Origuen J, Pintado V, Garcia-Vazquez E, Gasch O, Hamprecht A, Prim N, Tumbarello M, Bou G, Viale P, Tacconelli E, Almela M, Perez F, Giamarellou H, Cisneros JM, Schwaber MJ, Venditti M, Lowman W, Bermejo J, Hsueh PR, Mora-Rillo M, Gracia-Ahulfinger I, Pascual A, Rodriguez-Bano J; REIPI/ESGBIS/INCREMENT Group. Ertapenem for the treatment of bloodstream infections due to ESBL-producing Enterobacteriaceae: a multinational pre-registered cohort study. J Antimicrob Chemother. 2016 Jun;71(6):1672-80. doi: 10.1093/jac/dkv502. Epub 2016 Feb 22.
PubMed 26907184

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Specific Antimicrobials and Minimal Inhibitory Concentration(MIC) Values on the Outcome of Bloodstream Infections Due to ESBL or Carbapenemase-producing Enterobacteriaceae: an Observational Multinational Study
ClinicalTrials.gov ID: NCT01764490
Acronym / sponsor ID: INCREMENT / REIPI-1WP701
Conditions: Clinically Significant Bacteremia
Keywords: Bloodstream infections caused by multidrug-resistant Enterobacteriaceae, extended-spectrum β-lactamase-producers, carbapenemase-producing organisms
Study type: Observational
Recruitment status: Completed
Enrolment: 1,344 participants (actual)
Lead sponsor: JESUS RODRIGUEZ BAÑOUniversity, hospital or other
Study start: Jan 2013
Primary completion: Dec 2013 (actual)
Study completion: May 2014 (actual)
First posted: 9 Jan 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.

Main objective: to observationally assess the efficacy of different antimicrobials in Bloodstream Infection (BSI) due to Enterobacteriaceae producing ESBLs or carbapenemases.

Specific objectives:

Bacteraemic infections due to ESBL-producing Enterobacteriaceae:

To demonstrate that β-lactam/β-lactam inhibitors are not associated with worse cure rate and mortality than carbapenems after controlling for confounders, both as empirical and definitive therapy.
To demonstrate that fluoroquinolones as definitive therapy are not associated with worse cure rate and mortality than carbapenems after controlling for confounders.
To demonstrate that empirical cephalosporins in monotherapy are associated with worse cure rate and mortality than carbapenems after controlling for confounders in infections others than urinary tract infections.
To demonstrate that the association of active aminoglycosides with cephalosporins or fluoroquinolines is not associated with worse cure rate and mortality than carbapenems after controlling for confounders.
To demonstrate that combination empirical and definitive therapy is not associated with better cure rate than monotherapy after controlling for confounders.
For tigecycline, colistin, and fosfomycin, no hypothesis. The objective is to provide adjusted estimations of their association with outcome variables in comparison with carbapenem monotherapy according to clinical situation and infection.

Bacteraemic infections due to carbapenemase-producing Enterobacteriaceae:

To demonstrate that combination therapy is associated with worse cure rate and mortality than monotherapy after controlling for confounders.
To show that carbapenems are associated with worse cure rate and mortality when used in infections other than urinary tract caused by isolates showing MIC <2 µg/mL for imipenem or meropenem in comparison to those caused by isolates with higher MIC, after controlling for confounders.
To show that colistin used at a dose >6 million IU per day is associated with improved outcomes in comparison with lower dose, after controlling for confounders.

Detailed description

METHODS

Study design: multicentre, international retrospective cohort study.

Sites: multiple expert investigators from different countries are invited.

Conditions to fulfil to participate include availability of a database with the required data or ability to retrospectively collect the data in a timely manner.

Procedure

The participant centres are asked to include:

Previously published cases: all these cases should be included if possible. The fact that the case had been previously published should be specified in the database.
Additionally, participants are asked to include consecutive episodes detected by reviewing their databases (clinical, infection control or microbiological records) from January 2004 to June 2012, according to the following criteria:
For ESBL producers:

A minimum of 20 and a maximum of 50 cases should be included from each centre (the more recent ones should be selected).

Cases for which the enzyme is characterised at least to group level by polymerase chain reaction, PCR, (it is, CTX-M, SHV, TEM) should be prioritised despite the date of diagnosis.
If not enough number of cases with PCR-characterized enzymes are available, or PCR-characterisation has not been performed, the total number of cases should be completed by including cases in which ESBL-production was identified using a standard phenotypic method.
For carbapenemase-producers: only cases in which the carbapenemase was characterised by PCR should be included. All episodes up to a limit of 50 cases per centre may be included.

Overall, to avoid selection biases, consecutive cases according to previous criteria should be included.

Variables

A common online database has been designed. Individual access to the database will be provided.

Main outcome variable: Cure rate at day 14

Secondary outcome variables: Mortality at 72 hours, 7, 14 and 30 days, clinical improvement at 72 hours, clinical cure at day 28.

Explanatory variables:

Demographics
Severity of chronic underlying conditions: McCabe and Charlson index
Acute severity of underlying disease: Pitt score during the the day before BSI.
Type of acquisition
Source of BSI
Severity of SIRS at presentation
Microorganism, betalactamase, MICs
Empirical therapy
Definitive therapy

Statistical Analysis Plan

Subcohorts with patients treated with the treatment to be compared will be selected.
A propensity score to receive the 2 treatment types to compare will be calculated by obtaining a non-parsimonious multivariate model by logistic regression in which the outcome variable will be the treatment type. The explanatory variables will include age, gender, center, type of ward, acquisition, Charlson index, Pitt score, severity of SIRS and source.
After univariate analysis, multivariate analysis to investigate the adjusted association of treatment type with the main and secondary outcome variables will be performed by using logistic regression (for clinical response at day 14) and by Cox regression for mortality. If time until death is unavailable, logistic regression will be used for 30-day mortality. Logistic regression will also be used for 72-hour and 30-day clinical response. The propensity score will be added in all cases; also, Charlson score, Pitt score, severity of SIRS and source will be added. Finally, interaction between treatment type and source classified as urinary tract and others will be included.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: - Episode of clinically-significant monomicrobial BSI due to ESBL or carbapenemase-producing Enterobacteriaceae, including community and nosocomial ones

Key inclusion criteria (5 listed)

Episode of clinically-significant monomicrobial BSI due to ESBL or carbapenemase-producing Enterobacteriaceae, including community and nosocomial ones.
Subsequent episodes in a patient caused by the same microorganism may be included if the interval between them is >3 months.
No age limits.

Key exclusion criteria (3 listed)

Polymicrobial or non-clinically significant episodes. Episodes in which a potential contaminant (e.g., coagulase-negative staphylococci) is isolated only in one set of blood cultures and there is not a typical source of infection for that kind of organism (e.g. catheter-related) may be included.
Unavailability of key data (such cases should be counted to analyse a potential selection bias)
Episode occurring before January 2004.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Cure rate at day 14
Time frame: within the first 14 days after treatment started
o Cure: resolution of all signs and symptoms related to the infection, and antibiotic therapy is no longer necessary

6 secondary outcomes

Mortality at 72 hours
Time frame: within the first 72 hours
Mortality at 7 days
Time frame: within 7 days after treatment started
Mortality at 14 days
Time frame: within 14 days after treatment started
Mortality at 30 days
Time frame: within 30 days after treatment started
Clinical Improvement at 72 hours
Time frame: within the first 72 hours after treatment started
Clinical cure at 28 days
Time frame: within 28 days after treatment started

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 27 Jun 2014.
Derived from this study: PubMed 29618394Scheuerman O, Schechner V, Carmeli Y, Gutierrez-Gutierrez B, Calbo E, Almirante B, Viale PL, Oliver A, Ruiz-Garbajosa P, Gasch O, Gozalo M, Pitout J, Akova M, Pena C, Molina J, Hernandez-Torres A, Venditti M, Prim N, Origuen J, Bou G, Tacconelli E, Tumbarello M, Hamprecht A, Karaiskos I, de la Calle C, Perez F, Schwaber MJ, Bermejo J, Lowman W, Hsueh PR, Navarro-San Francisco C, Bonomo RA, Paterson DL, Pascual A, Rodriguez-Bano J; REIPI/ESGBIS/INCREMENT investigators. Comparison of Predictors and Mortality Between Bloodstream Infections Caused by ESBL-Producing Escherichia coli and ESBL-Producing Klebsiella pneumoniae. Infect Control Hosp Epidemiol. 2018 Jun;39(6):660-667. doi: 10.1017/ice.2018.63. Epub 2018 Apr 5.
Derived from this study: PubMed 28442293Gutierrez-Gutierrez B, Salamanca E, de Cueto M, Hsueh PR, Viale P, Pano-Pardo JR, Venditti M, Tumbarello M, Daikos G, Canton R, Doi Y, Tuon FF, Karaiskos I, Perez-Nadales E, Schwaber MJ, Azap OK, Souli M, Roilides E, Pournaras S, Akova M, Perez F, Bermejo J, Oliver A, Almela M, Lowman W, Almirante B, Bonomo RA, Carmeli Y, Paterson DL, Pascual A, Rodriguez-Bano J; REIPI/ESGBIS/INCREMENT Investigators. Effect of appropriate combination therapy on mortality of patients with bloodstream infections due to carbapenemase-producing Enterobacteriaceae (INCREMENT): a retrospective cohort study. Lancet Infect Dis. 2017 Jul;17(7):726-734. doi: 10.1016/S1473-3099(17)30228-1. Epub 2017 Apr 22.
Derived from this study: PubMed 27139473Gutierrez-Gutierrez B, Perez-Galera S, Salamanca E, de Cueto M, Calbo E, Almirante B, Viale P, Oliver A, Pintado V, Gasch O, Martinez-Martinez L, Pitout J, Akova M, Pena C, Molina J, Hernandez A, Venditti M, Prim N, Origuen J, Bou G, Tacconelli E, Tumbarello M, Hamprecht A, Giamarellou H, Almela M, Perez F, Schwaber MJ, Bermejo J, Lowman W, Hsueh PR, Mora-Rillo M, Natera C, Souli M, Bonomo RA, Carmeli Y, Paterson DL, Pascual A, Rodriguez-Bano J. A Multinational, Preregistered Cohort Study of beta-Lactam/beta-Lactamase Inhibitor Combinations for Treatment of Bloodstream Infections Due to Extended-Spectrum-beta-Lactamase-Producing Enterobacteriaceae. Antimicrob Agents Chemother. 2016 Jun 20;60(7):4159-69. doi: 10.1128/AAC.00365-16. Print 2016 Jul.
Derived from this study: PubMed 26907184Gutierrez-Gutierrez B, Bonomo RA, Carmeli Y, Paterson DL, Almirante B, Martinez-Martinez L, Oliver A, Calbo E, Pena C, Akova M, Pitout J, Origuen J, Pintado V, Garcia-Vazquez E, Gasch O, Hamprecht A, Prim N, Tumbarello M, Bou G, Viale P, Tacconelli E, Almela M, Perez F, Giamarellou H, Cisneros JM, Schwaber MJ, Venditti M, Lowman W, Bermejo J, Hsueh PR, Mora-Rillo M, Gracia-Ahulfinger I, Pascual A, Rodriguez-Bano J; REIPI/ESGBIS/INCREMENT Group. Ertapenem for the treatment of bloodstream infections due to ESBL-producing Enterobacteriaceae: a multinational pre-registered cohort study. J Antimicrob Chemother. 2016 Jun;71(6):1672-80. doi: 10.1093/jac/dkv502. Epub 2016 Feb 22.

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.

JESUS RODRIGUEZ BAÑO, MD, PhD study chair

Spanish Network for Research in Infectious Diseases

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Clinically Significant Bacteremia, run by JESUS RODRIGUEZ BAÑO at 1 site 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 5 inclusion and 3 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Cure rate at day 14 (time frame: within the first 14 days after treatment started). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01764490, which also lists 4 linked publications.

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 27 Jun 2014.