Severe SepsisNCT00934011
Use of Inflammatory Biomarkers to Guide Antibiotic Therapy in Patients With Severe Infections
A study testing C-reactive protein guided antibiotic therapy and Procalcitonin guided antibiotic therapy in people with Severe Sepsis and Septic Shock, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- C-reactive protein guided antibiotic therapy and Procalcitonin guided antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to May 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 17 years
- patients in intensive care unit
- signed informed consent
- suspected or confirmed severe sepsis or septic shock
Who cannot join
- Infections caused by Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis
- Bacteremia due S. aureus
- Infections requiring prolonged therapies, such as endocarditis, cerebral abscess, chronic osteomyelitis
- Suspected or confirmed infection caused by virus, parasites
- Infections caused by P. aeruginosa ou A. baumannii
- Severe immunosuppression (ex: AIDS, post bone-marrow transplant,cystic fibrosis)
Show all 9Show fewer
- Traumatism latest five days
- Surgery latest 5 days
- Carcinoid tumor, lung cancer, medullary thyroid cancer
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais
About this study
Official title: Comparative Study of C-reactive Protein vs. Procalcitonin to Guide Antibiotic Therapy in Patients With Severe Sepsis and Septic Shock Admitted to the Intensive Care Unit.
In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured.
Read the detailed description
Methods
- Patients and settings: Prospective controlled randomized open interventional study of antibiotic therapy in adult with severe sepsis or septic shock, admitted to the intensive care unit.
The study will be conducted in the intensive care unit (ICU) of the University Hospital Risoleta Tolentino Neves of the Federal University of Minas Gerais, Brazil. This is a 30-bed ICU with medical and surgical patients. All patients with suspected severe sepsis or septic shock admitted to the ICU will be assessed for eligibility. Patients developing severe sepsis or septic shock during their ICU stay will be also considered for enrollment.
Cultures of urine, blood, bronchoalveolar lavage fluid, and tracheal aspirates will be performed on admission and during ICU stay as clinically indicated. Blood gases and imaging exams will also be performed as clinically indicated, similarly in both groups.
- Interventions:
All adult (> 17 years old) patients with diagnosis of severe sepsis or septic shock will receive initial antibiotic therapy based on local guidelines and susceptibility patterns, according to the decision of the treating physician. They will have circulating PCT and CRP levels measured at baseline and daily until day 4 in both groups.
Eligible patients will be reassessed on day 4 and randomized at 1:1 basis to one of the two groups since any exclusion criteria (see below) is present at that time:
Group 1 - CRP group: the duration of antibiotic therapy will be based on circulating CRP levels.
Group 2 - PCT group: the duration of antibiotic therapy will be based on circulating PCT levels.
Patients enrolled in the study will undergo daily measurements of plasma CRP (Dry Chemistry - Johnsons \& Johnsons) and PCT (BRAHMS PCT VIDAS) levels up to stopping antibiotic therapy, every 48hr for two measurements in patients remaining in the ICU, and then, every 5 days.Patients will be followed up 28 days, or until death or hospital transference, which comes first. PCT and CRP results will be released in sealed envelopes. During the study period, only the results corresponding to the patient randomization group will be open; i.e., CRP for CRP group patients and PCT for PCT group patients.
- Criteria for antibiotic interruption:
The investigators will propose the interruption of antibiotics if:
- The patients is clinically stable, without signs of active infection
- CRP group: a relative reduction of 50% in baseline CRP levels, or a value lower than 25mg/dl is reached.
- PCT group: a relative reduction of 90% in baseline PCT levels, or if a absolute value lower than 0.1 ng/ml is reached.
The final decision regarding antibiotic therapy will be always let to the discretion of the treating physician.
- Conditions
- Severe Sepsis, Septic Shock
- Being tested
- C-reactive protein guided antibiotic therapy, Procalcitonin guided antibiotic therapy
- Keywords
- C-reactive protein, procalcitonin, sepsis, antibiotic therapy
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-reactive protein guided antibiotic therapyOther
plasma CRP measurement to guide the duration of antibiotic therapy
Procalcitonin guided antibiotic therapyOther
plasma PCT measurement to guide the duration of antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - C-reactive protein (CRP) guided ab therapy | Experimental | Intervention on antibiotic therapy will be based on circulating CRP levels Receives: Other: C-reactive protein guided antibiotic therapy |
| Group 2 - procalcitonin (PCT) guided ab therapy | Active comparator | Intervention on antibiotic therapy will be based on circulating PCT levels Receives: Other: Procalcitonin guided antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotic therapy for the first episode of infection
Measured: 28 days
Total antibiotic exposure days per 1,000 days
Measured: 28 days
Days alive without antibiotics
Measured: 28 days
Secondary outcomes (10)
All cause 28-day mortality
Measured: 28 days
clinical cure rate
Measured: 28 days
Infection relapse (diagnosed less than 48h after antibiotic discontinuation)
Measured: 48 hours
Length of ICU stay
Measured: Whole hospitalization
Nosocomial infection rate
Measured: 28 days
In-hospital mortality
Measured: 28 days
sepsis-associated death
Measured: 28 days
Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)
Measured: 28 days
Isolation of resistant bacteria
Measured: 28 days
Length of hospital stay
Measured: The whole hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionMay 2012
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 Severe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Vandack Alencar Nobre, Federal University of Minas Gerais
- Investigators
- Vandack A Nobre, PhD, Principal investigator, Medical School of the Federal University of Minas GeraisCarolina F Oliveira, MD, Study chair, IdemFernando A Botoni, PhD, Study chair, Idem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934011
- Sponsor's protocol ID
- PRO_Protocol01
- Status last verified
- Jun 2012
- First submitted
- 7 Jul 2009
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Results published in the Critical Care Medicine, 2013
Publications
Oliveira CF, Botoni FA, Oliveira CR, Silva CB, Pereira HA, Serufo JC, Nobre V. Procalcitonin versus C-reactive protein for guiding antibiotic therapy in sepsis: a randomized trial. Crit Care Med. 2013 Oct;41(10):2336-43. doi: 10.1097/CCM.0b013e31828e969f.
PubMed 23921272
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of C-reactive Protein vs. Procalcitonin to Guide Antibiotic Therapy in Patients With Severe Sepsis and Septic Shock Admitted to the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT00934011
- Acronym / sponsor ID
- PRO_Protocol01
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- C-reactive protein, procalcitonin, sepsis, antibiotic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Jul 2009 (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.
In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured.
Detailed description
Methods
- Patients and settings: Prospective controlled randomized open interventional study of antibiotic therapy in adult with severe sepsis or septic shock, admitted to the intensive care unit.
The study will be conducted in the intensive care unit (ICU) of the University Hospital Risoleta Tolentino Neves of the Federal University of Minas Gerais, Brazil. This is a 30-bed ICU with medical and surgical patients. All patients with suspected severe sepsis or septic shock admitted to the ICU will be assessed for eligibility. Patients developing severe sepsis or septic shock during their ICU stay will be also considered for enrollment.
Cultures of urine, blood, bronchoalveolar lavage fluid, and tracheal aspirates will be performed on admission and during ICU stay as clinically indicated. Blood gases and imaging exams will also be performed as clinically indicated, similarly in both groups.
- Interventions:
All adult (> 17 years old) patients with diagnosis of severe sepsis or septic shock will receive initial antibiotic therapy based on local guidelines and susceptibility patterns, according to the decision of the treating physician. They will have circulating PCT and CRP levels measured at baseline and daily until day 4 in both groups.
Eligible patients will be reassessed on day 4 and randomized at 1:1 basis to one of the two groups since any exclusion criteria (see below) is present at that time:
Group 1 - CRP group: the duration of antibiotic therapy will be based on circulating CRP levels.
Group 2 - PCT group: the duration of antibiotic therapy will be based on circulating PCT levels.
Patients enrolled in the study will undergo daily measurements of plasma CRP (Dry Chemistry - Johnsons \& Johnsons) and PCT (BRAHMS PCT VIDAS) levels up to stopping antibiotic therapy, every 48hr for two measurements in patients remaining in the ICU, and then, every 5 days.Patients will be followed up 28 days, or until death or hospital transference, which comes first. PCT and CRP results will be released in sealed envelopes. During the study period, only the results corresponding to the patient randomization group will be open; i.e., CRP for CRP group patients and PCT for PCT group patients.
- Criteria for antibiotic interruption:
The investigators will propose the interruption of antibiotics if:
- The patients is clinically stable, without signs of active infection
- CRP group: a relative reduction of 50% in baseline CRP levels, or a value lower than 25mg/dl is reached.
- PCT group: a relative reduction of 90% in baseline PCT levels, or if a absolute value lower than 0.1 ng/ml is reached.
The final decision regarding antibiotic therapy will be always let to the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - C-reactive protein (CRP) guided ab therapy | Experimental | Other: C-reactive protein guided antibiotic therapyIntervention on antibiotic therapy will be based on circulating CRP levels |
| Group 2 - procalcitonin (PCT) guided ab therapy | Active comparator | Other: Procalcitonin guided antibiotic therapyIntervention on antibiotic therapy will be based on circulating PCT levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 17 years
- patients in intensive care unit
- signed informed consent
- suspected or confirmed severe sepsis or septic shock
Key exclusion criteria (9 listed)
- Infections caused by Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis
- Bacteremia due S. aureus
- Infections requiring prolonged therapies, such as endocarditis, cerebral abscess, chronic osteomyelitis
- Suspected or confirmed infection caused by virus, parasites
- Infections caused by P. aeruginosa ou A. baumannii
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 |
|---|---|---|
| C-reactive protein guided antibiotic therapyplasma CRP measurement to guide the duration of antibiotic therapy | Other | Group 1 - C-reactive protein (CRP) guided ab therapy |
| Procalcitonin guided antibiotic therapyplasma PCT measurement to guide the duration of antibiotic therapy | Other | Group 2 - procalcitonin (PCT) guided ab therapy |
Primary outcome
Duration of antibiotic therapy for the first episode of infection
Time frame: 28 days
Total antibiotic exposure days per 1,000 days
Time frame: 28 days
Days alive without antibiotics
Time frame: 28 days
10 secondary outcomes
All cause 28-day mortality
Time frame: 28 days
clinical cure rate
Time frame: 28 days
Infection relapse (diagnosed less than 48h after antibiotic discontinuation)
Time frame: 48 hours
Length of ICU stay
Time frame: Whole hospitalization
Nosocomial infection rate
Time frame: 28 days
In-hospital mortality
Time frame: 28 days
sepsis-associated death
Time frame: 28 days
Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)
Time frame: 28 days
Isolation of resistant bacteria
Time frame: 28 days
Length of hospital stay
Time frame: The whole hospitalization
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 3 Feb 2016.
- Derived from this study: PubMed 23921272Oliveira CF, Botoni FA, Oliveira CR, Silva CB, Pereira HA, Serufo JC, Nobre V. Procalcitonin versus C-reactive protein for guiding antibiotic therapy in sepsis: a randomized trial. Crit Care Med. 2013 Oct;41(10):2336-43. doi: 10.1097/CCM.0b013e31828e969f.
- Individual participant dataSharing planned: Yes. Results published in the Critical Care Medicine, 2013
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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.
Vandack A Nobre, PhD principal investigator
Medical School of the Federal University of Minas Gerais
Carolina F Oliveira, MD study chair
Idem
Fernando A Botoni, PhD study chair
Idem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-reactive protein guided antibiotic therapy and Procalcitonin guided antibiotic therapy in people with Severe Sepsis and Septic Shock, run by Federal University of Minas Gerais 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 9 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 3 Feb 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.
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?
Duration of antibiotic therapy for the first episode of infection (time frame: 28 days). 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?
On the ClinicalTrials.gov record for NCT00934011, 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 3 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.