Enterobacteriaceae InfectionsPhase 3SHORTENNCT02400268
Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae
A Phase 3 study testing 7 days course of antibiotic treatment and 14 days course of antibiotic treatment in people with Enterobacteriaceae Infections and Bloodstream Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 4 sites in Spain.
Trial summary
The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria are becoming more and more frequent, and available antimicrobial agents are usually scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterobacteriaceae Infections, Bloodstream Infection
- What is being tested?
- 7 days course of antibiotic treatment and 14 days course of antibiotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 4 sitesSpain
- Study dates
- Sep 2014to 1 Mar 2017
- Phase
- Phase 3
- 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
- Adults patients (equal or over 18 years old)
- Primary or secondary bloodstream infection produced by enterobacteriaceae
- Source of bacteremia properly controlled or expect to be properly controlled in the next 24 hours (i.e. bacteremia produced by infected vascular catheter, abscess, obstruction of the biliary or urinary tract).
- Patients able to understand the objectives of the clinical trial and informed consent signed.
Who cannot join
- Pregnancy
- Post-chemotherapy neutropenia expected to persist more than 7 days.
- Source of bacteremia uncontrolled at inclusion period or in the following 24 hours. The source will be considered as uncontrolled if the bacteremia is secondary to a suppurative infection potentially removable, if no action has been taken to eradicate it, including: bacteremia by vascular not removed catheter, cholangitis secondary to not derived obstruction of the biliary tract, deep abscess not drained, pyohydronephrosis without derivation of the urinary tract.
- Bacteremia secondary to infective endocarditis, bone and joint infections, or neurosurgical infections, which may require prolonged antimicrobial therapy
- Bacteremia due to enterobacteriaceae resistant to carbapenemics.
- Polymicrobial bacteremia including microorganisms different to enterobacteriaceae.
- Patients with no expectations of survival in the next 48 hours of inclusion.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
University Hospital Reina Sofía
Córdoba, Córdoba, 14004
Universitary Hospital Málaga
Málaga, Málaga, 29010
University Hospital Virgen Macarena
Seville, Seville, 41007
Hospital Universitario Virgen del Rocío
Seville, Seville, 41013
About this study
Official title: Phase 4, Randomized, Controlled Multicentric, Open-label Clinical Trial to Prove That the 7 Day Course of Treatment for Enterobacteriaceae Bacteremia is More Efficient and Equally Safe Than 14 Day Scheme
The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria are becoming more and more frequent, and available antimicrobial agents are usually scarce. Reducing the duration of antimicrobial treatments is one of the most efficient measures to control the antibiotic pressure and to optimise the use of these agents.
Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal duration of antibiotics to treat them is unknown, as long as no clinical trials have been specifically developed to answer this question.
Read more
Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days. This represents a variability of up to 100%. No recommendations have been published regarding the duration of treatment of bacteremia from other sources.
The objective of this project is to prove that the 7-day course of treatment for EB bacteremia is more efficient and equally safe than the 14-day scheme.
Read the detailed description
To achieve theses objectives, we propose this randomized, multicentric clinical trial with a superiority design on the duration of antimicrobial treatment for EB bacteremia in adult patients.
- Being tested
- 7 days course of antibiotic treatment, 14 days course of antibiotic treatment
- Keywords
- Enterobacteriaceae, Bloodstream, Bacteremia, Recurrence, Reinfection
- Medical subject headings
- Enterobacteriaceae Infections, Sepsis, Bacteremia, Recurrence, Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 days course of antibiotic treatmentOther
Also called Antibiotics with approved indication
Standard antibiotic treatment approved for enterobacteraciae infections
14 days course of antibiotic treatmentOther
Also called Antibiotics with approved indication
Standard antibiotic treatment approved for enterobacteraciae infections
| Study group | Role | What they receive |
|---|---|---|
| 7 days course of antibiotic treatment | Experimental | Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines. Receives: Other: 7 days course of antibiotic treatment |
| 14 days course of antibiotic treatment | Active comparator | Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines. Receives: Other: 14 days course of antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of antimicrobial treatment
To prove that 7-days course of antibiotic therapy is more efficient than 14-days course when treating Enterobacteriaceae bacteremia, in terms of number of days at the end of follow up.
Measured: 28 days
Secondary outcomes (3)
Adverse reactions related to antimicrobial treatment
To prove that 7-days course of antibiotic therapy is as safe as a 14-days course in terms of : Rate of adverse effects including: adverse reactions to drugs, superinfections by resistant bacteria or diarrhea by Clostridium difficile, mortality, relapse of the infection
Measured: 28 days
Cure of bacteremia
Clinical and microbiological cure
Measured: 28 days
Procalcitonin levels
To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment of Enterobacteriaceae bacteremia
Measured: 7-days and 14-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startSep 2014
- Primary completion2 Dec 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterobacteriaceae InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Molina Gil-Bermejo, MD. PhD, Study director, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400268
- Sponsor's protocol ID
- SHORTEN
- Acronym
- SHORTEN
- Status last verified
- Mar 2017
- First submitted
- 5 Aug 2014
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonimized data for primary and secondary variables is planned to be shared with all the participants within 6 months of data completion.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Randomized, Controlled Multicentric, Open-label Clinical Trial to Prove That the 7 Day Course of Treatment for Enterobacteriaceae Bacteremia is More Efficient and Equally Safe Than 14 Day Scheme
- ClinicalTrials.gov ID
- NCT02400268
- Acronym / sponsor ID
- SHORTEN / SHORTEN
- Keywords
- Enterobacteriaceae, Bloodstream, Bacteremia, Recurrence, Reinfection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 27 Mar 2015 (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 antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria are becoming more and more frequent, and available antimicrobial agents are usually scarce. Reducing the duration of antimicrobial treatments is one of the most efficient measures to control the antibiotic pressure and to optimise the use of these agents.
Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal duration of antibiotics to treat them is unknown, as long as no clinical trials have been specifically developed to answer this question.
Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days. This represents a variability of up to 100%. No recommendations have been published regarding the duration of treatment of bacteremia from other sources.
The objective of this project is to prove that the 7-day course of treatment for EB bacteremia is more efficient and equally safe than the 14-day scheme.
Detailed description
To achieve theses objectives, we propose this randomized, multicentric clinical trial with a superiority design on the duration of antimicrobial treatment for EB bacteremia in adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 days course of antibiotic treatment | Experimental | Other: 7 days course of antibiotic treatmentAccepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines. |
| 14 days course of antibiotic treatment | Active comparator | Other: 14 days course of antibiotic treatmentAccepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults patients (equal or over 18 years old)
- Primary or secondary bloodstream infection produced by enterobacteriaceae
- Source of bacteremia properly controlled or expect to be properly controlled in the next 24 hours (i.e. bacteremia produced by infected vascular catheter, abscess, obstruction of the biliary or urinary tract).
- Patients able to understand the objectives of the clinical trial and informed consent signed.
Key exclusion criteria (7 listed)
- Pregnancy
- Post-chemotherapy neutropenia expected to persist more than 7 days.
- Source of bacteremia uncontrolled at inclusion period or in the following 24 hours. The source will be considered as uncontrolled if the bacteremia is secondary to a suppurative infection potentially removable, if no action has been taken to eradicate it, including: bacteremia by vascular not removed catheter, cholangitis secondary to not derived obstruction of the biliary tract, deep abscess not drained, pyohydronephrosis without derivation of the urinary tract.
- Bacteremia secondary to infective endocarditis, bone and joint infections, or neurosurgical infections, which may require prolonged antimicrobial therapy
- Bacteremia due to enterobacteriaceae resistant to carbapenemics.
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 |
|---|---|---|
| 7 days course of antibiotic treatmentAlso: Antibiotics with approved indicationStandard antibiotic treatment approved for enterobacteraciae infections | Other | 7 days course of antibiotic treatment |
| 14 days course of antibiotic treatmentAlso: Antibiotics with approved indicationStandard antibiotic treatment approved for enterobacteraciae infections | Other | 14 days course of antibiotic treatment |
Primary outcome
Days of antimicrobial treatment
Time frame: 28 days
To prove that 7-days course of antibiotic therapy is more efficient than 14-days course when treating Enterobacteriaceae bacteremia, in terms of number of days at the end of follow up.
3 secondary outcomes
Adverse reactions related to antimicrobial treatment
Time frame: 28 days
Cure of bacteremia
Time frame: 28 days
Procalcitonin levels
Time frame: 7-days and 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 13 Mar 2017.
- This organization is formed by 16 Spanish leading research groups in the field, is public funded by Spanish Carlos III Institute and co-financed by European Development Regional Fund (ERDF)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonimized data for primary and secondary variables is planned to be shared with all the participants within 6 months of data completion.
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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.
Jose Molina Gil-Bermejo, MD. PhD study director
Hospitales Universitarios Virgen del Rocío
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7 days course of antibiotic treatment and 14 days course of antibiotic treatment in people with Enterobacteriaceae Infections and Bloodstream Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 4 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 4 inclusion and 7 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Days of antimicrobial treatment (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 13 Mar 2017.