FeverPRONOURNCT00800488
Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months
An observational study of Fever and Bacterial Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants. 2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Read more about this study
- Who is it for?
- Ages 7 days to 3 months
- Conditions the study is for
- Fever, Bacterial Infection
- How many people
- 2,209 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Apr 2011
- 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 7 days to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: children 7 days older to 3 month older with fever
Who may be able to join
- Infant older than 7 days old and less than 3 months old.
- Fever (defined by a rectal temperature greater than or equal to 38°C)
- Emergency consultation
Who cannot join
- Infants with a previously identified immunodeficiency or chronic disease,
- Antibiotic treatment within the previous 48 hours
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric Emergency Depatment - Hôpital Antoine Béclère
Clamart, Hauts-de-Seine, 92140
About this study
Official title: Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months
The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants.
2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection.
Evaluation of the area under the ROC for Procalcitonin concentration.
Read the detailed description
Serious bacterial infections are often difficult to detect in infant with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.
- Conditions
- Fever, Bacterial Infection
- Keywords
- Fever, Infant, Procalcitonin, Serious Bacterial Infection
- Medical subject headings
- Fever, Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections
Measured: At the day of emergency consultation for fever
Secondary outcomes (3)
Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin
Measured: At the day of emergency consultation for fever
Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin
Measured: At the day of emergency consultation for fever
Diagnostic value (sensibility and specificity) of CRP versus procalcitonin
Measured: At the day of emergency consultation for fever
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GAJDOS, MD, Principal investigator, Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800488
- Sponsor's protocol ID
- AOR 06 047
- Acronym
- PRONOUR
- Status last verified
- Apr 2011
- First submitted
- 24 Nov 2008
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months
- ClinicalTrials.gov ID
- NCT00800488
- Acronym / sponsor ID
- PRONOUR / AOR 06 047
- Conditions
- Fever, Bacterial Infection
- Keywords
- Fever, Infant, Procalcitonin, Serious Bacterial Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,209 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Dec 2008 (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 primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants.
2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection.
Evaluation of the area under the ROC for Procalcitonin concentration.
Detailed description
Serious bacterial infections are often difficult to detect in infant with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children 7 days older to 3 month older with fever
Key inclusion criteria (3 listed)
- Infant older than 7 days old and less than 3 months old.
- Fever (defined by a rectal temperature greater than or equal to 38°C)
- Emergency consultation
Key exclusion criteria (2 listed)
- Infants with a previously identified immunodeficiency or chronic disease,
- Antibiotic treatment within the previous 48 hours
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
Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections
Time frame: At the day of emergency consultation for fever
3 secondary outcomes
Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin
Time frame: At the day of emergency consultation for fever
Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin
Time frame: At the day of emergency consultation for fever
Diagnostic value (sensibility and specificity) of CRP versus procalcitonin
Time frame: At the day of emergency consultation for fever
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 28 Jul 2014.
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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.
Vincent GAJDOS, MD principal investigator
Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
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 Fever and Bacterial Infection, 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 3 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 28 Jul 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 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?
Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections (time frame: At the day of emergency consultation for fever). 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 28 Jul 2014.