Bacterial InfectionsPRORATANCT00472667
PROcalcitonin Reduce Antibiotic Treatments in Acute-Ill Patients (PRORATA)
A study testing Procalcitonin guided strategy in people with Bacterial Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Procalcitonin guided strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to May 2008
- 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
- Patient hospitalised in the ICU
- Bacterial infection suspected
- At ICU admission the patient do not receive antibiotics or receive antibiotics for less than 24hours and an interval between admission and inclusion < 12 hours
- During ICU stay, provided that the interval between the start of suspected infection and inclusion is < 12hours
- Written inform consent from the patient or relatives. The consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives
Who cannot join
- Age < 18 years
- Pregnancy
- Patient expected to remain hospitalised in the ICU for less than 3 days
- Neutropenia
- Infection or presumed infection requiring prolonged antibiotic therapy (endocarditis,osteo-articular infection, mediastinitis, deep abscess, tuberculosis, pneumocystis pneumonia, toxoplasmosis).
- Simplified Acute Physiology Score II at ICU admission (calculated during the first 12h)
- Attending physician declining to use full life support.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
Read the detailed description
Clinical and laboratory signs are neither specific nor sensitive for diagnosis of sepsis in critically-ill patients. Because delaying antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU -patients, even when they are not needed. In addition, only few well-designed studies concerning the duration of antibiotic treatment have been so far published. Consequently, many patients received antibiotics during the ICU stay. Many studies have shown that exposure to antibiotics, the so called "selection pressure" is an independent risk factor for acquisition of resistance in individual patients. Therefore, reducing antibiotic use is probably necessary to control antibiotic resistance. Many clinical studies have shown that procalcitonin (PCT) is able to distinguish the inflammatory response to infection from other types of inflammation and to distinguish bacterial from viral infections. Recent studies have shown that PCT guidance substantially and safely reduced antibiotic overuse in patients with lower respiratory tract infections. We aimed to evaluate the role of PCT in reducing the use of antibiotics in ICU adult patients. The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
- Conditions
- Bacterial Infections
- Being tested
- Procalcitonin guided strategy
- Keywords
- Bacterial infections, Procalcitonin, Intensive care unit, Antibiotic therapy, Suspicion of bacterial infection or proven
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin guided strategyProcedure or surgery
Procalcitonin guided strategy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Procalcitonin guided strategy Receives: Procedure: Procalcitonin guided strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposition to antibiotics, defined by antibiotic-free days
Measured: assessed 28 days after inclusion
Mortality
Measured: at Day 28 and Day 60
Secondary outcomes (7)
Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days
Measured: between D1 and D28
The length of ICU and hospital stay
Measured: during the stay at the hospital
The evolution of SOFA score parameters
Measured: between D1 and D28
The number of mechanical ventilation-free days
Measured: at D28
The acquisition cost of antibiotics
Measured: between D1 and D28
The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples.
Measured: between D1 and D28
The percentages of relapses of infection
Measured: between D1 and D28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
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 Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Lila BOUADMA, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472667
- Sponsor's protocol ID
- P060204
- Other IDs
- AOR06019
- Acronym
- PRORATA
- Status last verified
- May 2007
- First submitted
- 11 May 2007
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Regnier B, Brun-Buisson C, Chastre J, Wolff M; PRORATA trial group. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25.
PubMed 20097417
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
- ClinicalTrials.gov ID
- NCT00472667
- Acronym / sponsor ID
- PRORATA / P060204
- Conditions
- Bacterial Infections
- Keywords
- Bacterial infections, Procalcitonin, Intensive care unit, Antibiotic therapy, Suspicion of bacterial infection or proven
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 May 2007 (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 study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
Detailed description
Clinical and laboratory signs are neither specific nor sensitive for diagnosis of sepsis in critically-ill patients. Because delaying antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU -patients, even when they are not needed. In addition, only few well-designed studies concerning the duration of antibiotic treatment have been so far published. Consequently, many patients received antibiotics during the ICU stay. Many studies have shown that exposure to antibiotics, the so called "selection pressure" is an independent risk factor for acquisition of resistance in individual patients. Therefore, reducing antibiotic use is probably necessary to control antibiotic resistance. Many clinical studies have shown that procalcitonin (PCT) is able to distinguish the inflammatory response to infection from other types of inflammation and to distinguish bacterial from viral infections. Recent studies have shown that PCT guidance substantially and safely reduced antibiotic overuse in patients with lower respiratory tract infections. We aimed to evaluate the role of PCT in reducing the use of antibiotics in ICU adult patients. The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Procalcitonin guided strategyProcalcitonin guided strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient hospitalised in the ICU
- Bacterial infection suspected
- At ICU admission the patient do not receive antibiotics or receive antibiotics for less than 24hours and an interval between admission and inclusion < 12 hours
- During ICU stay, provided that the interval between the start of suspected infection and inclusion is < 12hours
- Written inform consent from the patient or relatives. The consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives
Key exclusion criteria (7 listed)
- Age < 18 years
- Pregnancy
- Patient expected to remain hospitalised in the ICU for less than 3 days
- Neutropenia
- Infection or presumed infection requiring prolonged antibiotic therapy (endocarditis,osteo-articular infection, mediastinitis, deep abscess, tuberculosis, pneumocystis pneumonia, toxoplasmosis).
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 guided strategyProcalcitonin guided strategy | Procedure or surgery | 1 |
Primary outcome
Exposition to antibiotics, defined by antibiotic-free days
Time frame: assessed 28 days after inclusion
Mortality
Time frame: at Day 28 and Day 60
7 secondary outcomes
Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days
Time frame: between D1 and D28
The length of ICU and hospital stay
Time frame: during the stay at the hospital
The evolution of SOFA score parameters
Time frame: between D1 and D28
The number of mechanical ventilation-free days
Time frame: at D28
The acquisition cost of antibiotics
Time frame: between D1 and D28
The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples.
Time frame: between D1 and D28
The percentages of relapses of infection
Time frame: between D1 and D28
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 25 Nov 2008.
- Derived from this study: PubMed 20097417Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Regnier B, Brun-Buisson C, Chastre J, Wolff M; PRORATA trial group. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25.
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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.
Lila BOUADMA, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 guided strategy in people with Bacterial Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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 25 Nov 2008. 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 France. 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?
Exposition to antibiotics, defined by antibiotic-free days (time frame: assessed 28 days after inclusion). The study lists 2 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 NCT00472667, 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 25 Nov 2008.