SepsisPhase 4NCT01450358
Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.
A Phase 4 study testing Antibiotic regimen in people with Sepsis and Bacteremia, run by Instituto do Coracao at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate the consumption of antimicrobial therapy in patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis, Bacteremia, Fungemia
- What is being tested?
- Antibiotic regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to May 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18 or more years old
- Patient staying more than 48 hours in hospital
- Patient with clinical suspicion of infection and presenting at leat two of the following criteria:temperature > 38oC or < 36oC, heart rate > 90 beats/minute, respiratory rate > 20 breaths/minute or PaCO2 < 32 mmHg or leukocytosis >12 000/μl or leukopenia <4000/μl or normal white blood cell count with >10% immature forms
- Patient or responsible able to provide informed consent
Who cannot join
- Patient submitted to cardiovascular surgery in the last fifteen days
- Patient or responsible are not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Antimicrobial Use and Time of Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction (PCR) in Real Time Multiplex to the Conventional Blood Culture for Etiologic Agents Identification. Randomized Clinical Trial.
The objective of this study is to evaluate the consumption of antimicrobial therapy in patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis.
Read the detailed description
Patients staying more than 48 hours in hospital with clinical suspicion of sepsis could be included in the study. Blood samples for cultures and multiplex PCR will be collected immediately prior to initiation of antibiotic therapy. Patients will be randomly selected into two groups. In Group I, the PCR results will be immediately reported to the medical researcher (6-12 hours), which will change the antimicrobial regimen (De-escalation). In Group II, the Multiplex PCR results will not be informed, being focused care as a result of blood culture (at least after 72 hours). The initial empirical antimicrobial therapy will be the same in both groups, according to the standardization of the institution.
- Conditions
- Sepsis, Bacteremia, Fungemia
- Being tested
- Antibiotic regimen
- Keywords
- Sepsis, Real time PCR, Blood culture, Bacteremia diagnosis, Fungemia diagnosis
- Medical subject headings
- Sepsis, Bacteremia, Fungemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic regimenOther
The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR (6-12 h).
| Study group | Role | What they receive |
|---|---|---|
| Pathogen detection by Multiplex PCR | Active comparator | Blood samples for cultures and Multiplex PCR will be collected before start the antibiotic therapy in patients with sepsis. Multiplex PCR will be immediately undertaken and its results will be reported to prompt medical researcher (6-12 hours).The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR. Receives: Other: Antibiotic regimen |
| Pathogen detection by blood culture | No intervention | Blood samples for cultures and Multiplex PCR will be collected before start the antibiotic therapy in patients with sepsis. The results of multiplex PCR will be not informed to the medical researcher, being focused care as a result of blood culture (at least after 72 hours). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of antimicrobial use in number of days comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis.
Measured: After fourteen days of antimicrobial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionMay 2016
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 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Tania Mara Varejão Strabelli, Instituto do Coracao
- Investigators
- Tania MV Strabelli, PhD, Principal investigator, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450358
- Sponsor's protocol ID
- PCR multiplex
- Status last verified
- Jun 2016
- First submitted
- 10 Oct 2011
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodrigues C, Siciliano RF, Filho HC, Charbel CE, de Carvalho Sarahyba da Silva L, Baiardo Redaelli M, de Paula Rosa Passetti AP, Franco MRG, Rossi F, Zeigler R, De Backer D, Franco RA, de Almeida JP, Rizk SI, Fukushima JT, Landoni G, Uip DE, Hajjar LA, Strabelli TMV. The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial. J Intensive Care. 2019 Jul 22;7:37. doi: 10.1186/s40560-019-0391-3. eCollection 2019.
PubMed 31367384
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antimicrobial Use and Time of Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction (PCR) in Real Time Multiplex to the Conventional Blood Culture for Etiologic Agents Identification. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01450358
- Acronym / sponsor ID
- PCR multiplex
- Conditions
- Sepsis, Bacteremia, Fungemia
- Keywords
- Sepsis, Real time PCR, Blood culture, Bacteremia diagnosis, Fungemia diagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Instituto do CoracaoOther government
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Oct 2011 (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 objective of this study is to evaluate the consumption of antimicrobial therapy in patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis.
Detailed description
Patients staying more than 48 hours in hospital with clinical suspicion of sepsis could be included in the study. Blood samples for cultures and multiplex PCR will be collected immediately prior to initiation of antibiotic therapy. Patients will be randomly selected into two groups. In Group I, the PCR results will be immediately reported to the medical researcher (6-12 hours), which will change the antimicrobial regimen (De-escalation). In Group II, the Multiplex PCR results will not be informed, being focused care as a result of blood culture (at least after 72 hours). The initial empirical antimicrobial therapy will be the same in both groups, according to the standardization of the institution.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathogen detection by Multiplex PCR | Active comparator | Other: Antibiotic regimenBlood samples for cultures and Multiplex PCR will be collected before start the antibiotic therapy in patients with sepsis. Multiplex PCR will be immediately undertaken and its results will be reported to prompt medical researcher (6-12 hours).The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR. |
| Pathogen detection by blood culture | No intervention | –Blood samples for cultures and Multiplex PCR will be collected before start the antibiotic therapy in patients with sepsis. The results of multiplex PCR will be not informed to the medical researcher, being focused care as a result of blood culture (at least after 72 hours). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient 18 or more years old
- Patient staying more than 48 hours in hospital
- Patient with clinical suspicion of infection and presenting at leat two of the following criteria:temperature > 38oC or < 36oC, heart rate > 90 beats/minute, respiratory rate > 20 breaths/minute or PaCO2 < 32 mmHg or leukocytosis >12 000/μl or leukopenia <4000/μl or normal white blood cell count with >10% immature forms
- Patient or responsible able to provide informed consent
Key exclusion criteria (2 listed)
- Patient submitted to cardiovascular surgery in the last fifteen days
- Patient or responsible are not able to provide informed consent
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 |
|---|---|---|
| Antibiotic regimenThe medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR (6-12 h). | Other | Pathogen detection by Multiplex PCR |
Primary outcome
Evaluation of antimicrobial use in number of days comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis.
Time frame: After fourteen days of antimicrobial treatment
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 9 Jun 2016.
- Derived from this study: PubMed 31367384Rodrigues C, Siciliano RF, Filho HC, Charbel CE, de Carvalho Sarahyba da Silva L, Baiardo Redaelli M, de Paula Rosa Passetti AP, Franco MRG, Rossi F, Zeigler R, De Backer D, Franco RA, de Almeida JP, Rizk SI, Fukushima JT, Landoni G, Uip DE, Hajjar LA, Strabelli TMV. The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial. J Intensive Care. 2019 Jul 22;7:37. doi: 10.1186/s40560-019-0391-3. eCollection 2019.
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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.
Tania MV Strabelli, PhD principal investigator
Instituto do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic regimen in people with Sepsis and Bacteremia, run by Instituto do Coracao at 1 site in Brazil.
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 2 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 9 Jun 2016. 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 Brazil. 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?
Evaluation of antimicrobial use in number of days comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis. (time frame: After fourteen days of antimicrobial treatment). 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 NCT01450358, 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 9 Jun 2016.