SepsisNCT01494675
Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU
A study testing procalcitonin measurement in people with Sepsis, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Recently, biomarkers like procalcitonin have been studied in order to help physicians to decrease the duration of the antibiotic therapy. The investigators objective was to assess whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy in critically ill patients with a proven… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- procalcitonin measurement
- How many people
- 81 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Feb 2010
- 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
- all patients admitted in the intensive care unit with sepsis, severe sepsis and septic shock with a microbiologically confirmed infection (blood, urine, tracheal aspirate or bronchoalveolar fluid culture)
Who cannot join
- onset of the antibiotic therapy more than 48 hours before the date when the cultures were performed
- patients less than 18 years old
- known pregnancy
- infections requiring prolonged antibotic therapy such as endocarditis, hepatic or brain abscess, deep abscess, mediastinitis and osteomyelitis
- severe infection caused by virus, parasites, fungi or chronic prostatitis
- negative cultures in patients with suspected sepsis, severe sepsis or septic shock
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, Sâo Paulo, 05641-901
About this study
Official title: Clinical Impact of Procalcitonin to Shorten Antimicrobial Therapy in Septic Patients With Proven Bacterial Infection in an Intensive Care Setting
Recently, biomarkers like procalcitonin have been studied in order to help physicians to decrease the duration of the antibiotic therapy. The investigators objective was to assess whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy in critically ill patients with a proven infection without risking a worse outcome.
- Conditions
- Sepsis
- Being tested
- procalcitonin measurement
- Keywords
- procalcitonin, duration of the antibiotic therapy, sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitonin measurementOther
The patients assigned to the procalcitonin group had procalcitonin and C reactive protein levels measured at day 0 (bacteremia), 5 or 7 (if positive blood culture) and then every 48 hours until hosptital discharge, death or until the antibiotics were stopped. A predefined procalcitonin protocol was used together with the clinical outcome, to guide the physician´s decision to discontinue antibiotics.
The procalcitonin protocol encouraged the physician to discontinue the antibiotics when: 1)procalcitonin dropped more than 90% from the baseline peak level or 2)an absolute value below 0,5ng/mL was reached. Cases in which the antibiotic treatment was continued against what the PCT values indicated were categorized as " antibiotic discontinuation overruling"
What is being measured
The primary outcome is the main question the study is designed to answer.
reducing the duration of antibiotic therapy
the primary objective was to assess if a procalcitonin measurement protocol can reduce the duration of antibiotic therapy in critically ill patients with sepsis, severe sepsis and septic shock with documented infection
Measured: 2 years
Secondary outcomes (1)
all cause mortality
The secondary endpoints were in-hospital mortality, ICU mortality, ICU length of stay, recurrence of the initial infection, analyis of the C-reative protein levels along with the procalcitonin protocol and costs
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startMar 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Octavio Deliberato, Hospital Israelita Albert Einstein
- Investigators
- Rodrigo O Deliberato, M.D., Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494675
- Sponsor's protocol ID
- PCT
- Status last verified
- Dec 2011
- First submitted
- 13 Dec 2011
- Last updated
- 19 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Procalcitonin to Shorten Antimicrobial Therapy in Septic Patients With Proven Bacterial Infection in an Intensive Care Setting
- ClinicalTrials.gov ID
- NCT01494675
- Acronym / sponsor ID
- PCT
- Conditions
- Sepsis
- Keywords
- procalcitonin, duration of the antibiotic therapy, sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Dec 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.
Recently, biomarkers like procalcitonin have been studied in order to help physicians to decrease the duration of the antibiotic therapy. The investigators objective was to assess whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy in critically ill patients with a proven infection without risking a worse outcome.
Study design
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients admitted in the intensive care unit with sepsis, severe sepsis and septic shock with a microbiologically confirmed infection (blood, urine, tracheal aspirate or bronchoalveolar fluid culture)
Key exclusion criteria (6 listed)
- onset of the antibiotic therapy more than 48 hours before the date when the cultures were performed
- patients less than 18 years old
- known pregnancy
- infections requiring prolonged antibotic therapy such as endocarditis, hepatic or brain abscess, deep abscess, mediastinitis and osteomyelitis
- severe infection caused by virus, parasites, fungi or chronic prostatitis
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 |
|---|---|---|
| procalcitonin measurementThe patients assigned to the procalcitonin group had procalcitonin and C reactive protein levels measured at day 0 (bacteremia), 5 or 7 (if positive blood culture) and then every 48 hours until hosptital discharge, death or until the antibiotics were stopped. A predefined procalcitonin protocol was used together with the clinical outcome, to guide the physician´s decision to discontinue antibiotics. The procalcitonin protocol encouraged the physician to discontinue the antibiotics when: 1)procalcitonin dropped more than 90% from the baseline peak level or 2)an absolute value below 0,5ng/mL was reached. Cases in which the antibiotic treatment was continued against what the PCT values indicated were categorized as " antibiotic discontinuation overruling" | Other | – |
Primary outcome
reducing the duration of antibiotic therapy
Time frame: 2 years
the primary objective was to assess if a procalcitonin measurement protocol can reduce the duration of antibiotic therapy in critically ill patients with sepsis, severe sepsis and septic shock with documented infection
1 secondary outcome
all cause mortality
Time frame: 2 years
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 19 Dec 2011.
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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.
Rodrigo O Deliberato, M.D. principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procalcitonin measurement in people with Sepsis, run by Hospital Israelita Albert Einstein 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 1 inclusion and 6 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 19 Dec 2011. 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?
reducing the duration of antibiotic therapy (time frame: 2 years). 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 19 Dec 2011.