Antibiotic Resistant InfectionNO-BACTNCT03535324
Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (NO-BACT)
A study testing PROA for optimization in people with Antibiotic Resistant Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 3 sites in Spain.
Trial summary
Patients with negative blood cultures represent 85-90 % from all patients with a blood culture taken during hospital admissions. This population usually includes an heterogeneous group of patients that are admitted because of an infectious diseases or febrile syndrome in which performing a blood culture is required. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistant Infection
- What is being tested?
- PROA for optimization
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 3 sitesSpain
- Study dates
- 5 Oct 2018to 31 May 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health professionals in charge of patients with negative hemoculture and active antibiotherapy within 48 hours of extraction; and that belong to a clinical unit that has been assigned to the intervention arm.
Who cannot join
- Health professionals in charge of patients who, even if they meet the criteria described above, will not be considered to have a foreseeable death within <72hrs from the hemoculture extraction or a positive hemoculture in the seven days prior to the extraction of the negative hemoculture.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Puerta del Mar Hospital
Cadiz, 11009
Virgen Macarena Hospital
Seville, 41009
Lozano Blesa Hospital
Zaragoza, 50009
About this study
Official title: Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (The NO-BACT Project)
Patients with negative blood cultures represent 85-90 % from all patients with a blood culture taken during hospital admissions. This population usually includes an heterogeneous group of patients that are admitted because of an infectious diseases or febrile syndrome in which performing a blood culture is required. There is scarce evidence about the clinical characteristics and the antibiotic treatment given to these patients. This project will be developped in two phases with an specific target in each one:
- Phase I (a cohort study of patient with blood cultured taken): the investigators aim to analyse the clinical and therapeutics characteristics, outcomes and antimicrobial stewardship oppotunities in a population of patients with negative blood culture. The investigators aim to compare the outcomes and antimicrobial stewardship opportunities with those in patients with positive blood culture.
- Phase II: The investigators will develop a cluster randomised control trial to evaluate the implementation of a targeted antimicrobial stewardship intervention in patients with negative blood culture (based on 3rd and 5th day audits). The effect of the intervention on the quality of antimicrobial use (duration and de-escalation), long of stay and mortality will be analysed.
- Conditions
- Antibiotic Resistant Infection
- Being tested
- PROA for optimization, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROA for optimizationBehavioural
The development of a ASP based on Reinforcement, Guidance and Support Programs, to prescribing physicians for the optimization of antimicrobial use based on a non-tax counseling program and evidence-based recommendations.
ControlOther
There will be no intervention
| Study group | Role | What they receive |
|---|---|---|
| PROA for optimization | Experimental | Development of a Program for optimizing the use of antibiotics (PROA) in Spanish (Antimicrobial Stewardship Program, ASP, in English), based on Reinforcement, Guidance and Support Programs, to prescribing physicians for the optimization of antimicrobial use based on a non-tax counseling program and evidence-based recommendations. The intervention will be carried out at the cluster level (group of patients belonging to a specific hospital service that meet the inclusion criteria). The intervention will consist in carrying out the audit with recommendation on days 3 and 5-7 after the extraction of negative blood cultures to assess the possibilities of de-escalation, sequential oral therapy and end of early treatment based on the available evidence. Receives: Behavioral: PROA for optimization |
| Control | Other | There will be no intervention. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of treatment (DDT)
Days of treatment per negative hemoculture episode evaluated
Measured: It will be variable because each individual can have a different treatment days that will vary based on our previous experience between 2 and 28 days . They will be measured only once for each case included.
Secondary outcomes (5)
Defined Daily Doses (DDDS)
Defined Daily Doses of antibiotic used in each episode
Measured: Weekly from date of randomization up to 28 days
30-day mortality
Mortality at 30 days after the extraction of the blood culture.
Measured: From 4 to 30 days since only those patients with active antibiotherapy are included at 48 hours and with no death forecast before 48-72 hours after inclusion
Re-hospitalization in the next 90 days
Re-hospitalization in the next 90 days after the extraction of the blood culture.
Measured: From 4 to 90 days
Superinfection by multiresistant microorganisms
Rate of reinfection by MDR (multidrug-resistant) bacteria (according to Magiorakos AP et al criteria - International standard definitions for acquired resistance, Clin Microbiol Infect, 2011) among the intervention group patients comparing to rate in the control group patients
Measured: In the first three months after the negative blood culture
Clostridium difficile diarrhea
Rate of patients presenting confirmed Clostridium difficile (CD) diarrhea among the intervention group patients comparing to rate of CD diarrhea about control group patients.
Measured: In the first three months after the negative blood culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start5 Oct 2018
- Primary completion30 Jun 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant InfectionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 659 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
- Pilar Retamar Gentil, MD/PhD, Study director, Virgen Macarena Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535324
- Sponsor's protocol ID
- NO-BACT (FIS-ANT-2018-01)
- Acronym
- NO-BACT
- Status last verified
- Apr 2024
- First submitted
- 8 May 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jimenez-Jorge S, Palacios-Baena ZR, Rosso-Fernandez CM, Giron-Ortega JA, Rodriguez-Bano J, Retamar P. Opportunities for antibiotic optimisation and outcome improvement in patients with negative blood cultures: study protocol for a cluster-randomised crossover trial, the NO-BACT study. BMJ Open. 2019 Dec 18;9(12):e030062. doi: 10.1136/bmjopen-2019-030062.
PubMed 31857298
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (The NO-BACT Project)
- ClinicalTrials.gov ID
- NCT03535324
- Acronym / sponsor ID
- NO-BACT / NO-BACT (FIS-ANT-2018-01)
- Conditions
- Antibiotic Resistant Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 24 May 2018 (actual)
- 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.
Patients with negative blood cultures represent 85-90 % from all patients with a blood culture taken during hospital admissions. This population usually includes an heterogeneous group of patients that are admitted because of an infectious diseases or febrile syndrome in which performing a blood culture is required. There is scarce evidence about the clinical characteristics and the antibiotic treatment given to these patients. This project will be developped in two phases with an specific target in each one:
- Phase I (a cohort study of patient with blood cultured taken): the investigators aim to analyse the clinical and therapeutics characteristics, outcomes and antimicrobial stewardship oppotunities in a population of patients with negative blood culture. The investigators aim to compare the outcomes and antimicrobial stewardship opportunities with those in patients with positive blood culture.
- Phase II: The investigators will develop a cluster randomised control trial to evaluate the implementation of a targeted antimicrobial stewardship intervention in patients with negative blood culture (based on 3rd and 5th day audits). The effect of the intervention on the quality of antimicrobial use (duration and de-escalation), long of stay and mortality will be analysed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROA for optimization | Experimental | Behavioral: PROA for optimizationDevelopment of a Program for optimizing the use of antibiotics (PROA) in Spanish (Antimicrobial Stewardship Program, ASP, in English), based on Reinforcement, Guidance and Support Programs, to prescribing physicians for the optimization of antimicrobial use based on a non-tax counseling program and evidence-based recommendations. The intervention will be carried out at the cluster level (group of patients belonging to a specific hospital service that meet the inclusion criteria). The intervention will consist in carrying out the audit with recommendation on days 3 and 5-7 after the extraction of negative blood cultures to assess the possibilities of de-escalation, sequential oral therapy and end of early treatment based on the available evidence. |
| Control | Other | Other: ControlThere will be no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health professionals in charge of patients with negative hemoculture and active antibiotherapy within 48 hours of extraction; and that belong to a clinical unit that has been assigned to the intervention arm.
Key exclusion criteria (1 listed)
- Health professionals in charge of patients who, even if they meet the criteria described above, will not be considered to have a foreseeable death within <72hrs from the hemoculture extraction or a positive hemoculture in the seven days prior to the extraction of the negative hemoculture.
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 |
|---|---|---|
| PROA for optimizationThe development of a ASP based on Reinforcement, Guidance and Support Programs, to prescribing physicians for the optimization of antimicrobial use based on a non-tax counseling program and evidence-based recommendations. | Behavioural | PROA for optimization |
| ControlThere will be no intervention | Other | Control |
Primary outcome
Days of treatment (DDT)
Time frame: It will be variable because each individual can have a different treatment days that will vary based on our previous experience between 2 and 28 days . They will be measured only once for each case included.
Days of treatment per negative hemoculture episode evaluated
5 secondary outcomes
Defined Daily Doses (DDDS)
Time frame: Weekly from date of randomization up to 28 days
30-day mortality
Time frame: From 4 to 30 days since only those patients with active antibiotherapy are included at 48 hours and with no death forecast before 48-72 hours after inclusion
Re-hospitalization in the next 90 days
Time frame: From 4 to 90 days
Superinfection by multiresistant microorganisms
Time frame: In the first three months after the negative blood culture
Clostridium difficile diarrhea
Time frame: In the first three months after the negative blood culture
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 11 Apr 2024.
- Derived from this study: PubMed 31857298Jimenez-Jorge S, Palacios-Baena ZR, Rosso-Fernandez CM, Giron-Ortega JA, Rodriguez-Bano J, Retamar P. Opportunities for antibiotic optimisation and outcome improvement in patients with negative blood cultures: study protocol for a cluster-randomised crossover trial, the NO-BACT study. BMJ Open. 2019 Dec 18;9(12):e030062. doi: 10.1136/bmjopen-2019-030062.
- Individual participant dataSharing planned: No
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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.
Pilar Retamar Gentil, MD/PhD study director
Virgen Macarena Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROA for optimization in people with Antibiotic Resistant Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 3 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 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Days of treatment (DDT) (time frame: It will be variable because each individual can have a different treatment days that will vary based on our previous experience between 2 and 28 days . They will be measured only once for each case included.). 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 NCT03535324, which also lists 1 linked publication.
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 11 Apr 2024.