Secondary or Tertiary PeritonitisNCT01155739
Procalcitonin as a Marker for the Length of Antibiotic Treatment in Peritonitis and Intra-abdominal Infections
An observational study of Secondary or Tertiary Peritonitis, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Procalcitonin level used for determining length of antibiotic treatment in peritonitis and intra-abdominal infections. Hypothesis is that length of antibiotic use can be shortened by this method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary or Tertiary Peritonitis
- How many people
- 162 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Jun 2014
- Phase
- Observational
- 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
Study population: hospitalized patients with SIRS due to peritonitis or intra-abdominal infections
Who may be able to join
- More than 18 yo
- Patient requiring surgery for peritonitis or intra-abdominal infection following: perforation, necrosis, previous operation...
- Mannheim Peritonitis score > 14
- SIRS present
- Probability of survival > 72h
- Informed consent by patient/relatives
Who cannot join
- No SIRS
- Long date corticoid treatment
- Immunosuppression
- Thyroid medullary carcinoma
- Anaphylactic shock
- Acute hepatic deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude Prospective Sur l'Impact de l'Utilisation de la Procalcitonine Dans l'évaluation de la Poursuite ou de l'arrêt du Traitement Antibiotique Empirique Lors de péritonites et d'Infections Intra-abdominales
Procalcitonin level used for determining length of antibiotic treatment in peritonitis and intra-abdominal infections. Hypothesis is that length of antibiotic use can be shortened by this method.
Read the detailed description
Prospective randomized trial
- Conditions
- Secondary or Tertiary Peritonitis
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| procalcitonine monitoring | PCT group: antibiotic use is tailored by serum procalcitonin values, determined every 48houres. | |
| control group | control group: antibiotic use and length of treatment as defined by guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibiotic treatment length, hospitalisation length without antibiotic, infection recurrence, antibiotic cost
Measured: at one month and during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary or Tertiary PeritonitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Steve Aellen, MD, Principal investigator, Department of visceral surgery, university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155739
- Sponsor's protocol ID
- 141/08, Propéritonite
- Status last verified
- Dec 2014
- First submitted
- 23 Jul 2009
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Prospective Sur l'Impact de l'Utilisation de la Procalcitonine Dans l'évaluation de la Poursuite ou de l'arrêt du Traitement Antibiotique Empirique Lors de péritonites et d'Infections Intra-abdominales
- ClinicalTrials.gov ID
- NCT01155739
- Acronym / sponsor ID
- 141/08, Propéritonite
- Conditions
- Secondary or Tertiary Peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Jul 2010 (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.
Procalcitonin level used for determining length of antibiotic treatment in peritonitis and intra-abdominal infections. Hypothesis is that length of antibiotic use can be shortened by this method.
Detailed description
Prospective randomized trial
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| procalcitonine monitoring | – | –PCT group: antibiotic use is tailored by serum procalcitonin values, determined every 48houres. |
| control group | – | –control group: antibiotic use and length of treatment as defined by guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients with SIRS due to peritonitis or intra-abdominal infections
Key inclusion criteria (6 listed)
- More than 18 yo
- Patient requiring surgery for peritonitis or intra-abdominal infection following: perforation, necrosis, previous operation...
- Mannheim Peritonitis score > 14
- SIRS present
- Probability of survival > 72h
Key exclusion criteria (6 listed)
- No SIRS
- Long date corticoid treatment
- Immunosuppression
- Thyroid medullary carcinoma
- Anaphylactic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
antibiotic treatment length, hospitalisation length without antibiotic, infection recurrence, antibiotic cost
Time frame: at one month and during hospital stay
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 2014.
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.
Steve Aellen, MD principal investigator
Department of visceral surgery, university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary or Tertiary Peritonitis, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 6 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 2014. 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 Switzerland. 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?
antibiotic treatment length, hospitalisation length without antibiotic, infection recurrence, antibiotic cost (time frame: at one month and during hospital stay). 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 2014.