ProcalcitoninNCT00692848
Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
A study testing Procalcitonin dosage PCT-Q test (Brahms, Germany) in people with Procalcitonin and Fever Without Source, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Serious bacterial infections are often difficult to detect in children 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. Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Procalcitonin, Fever Without Source, Bacterial Infection
- What is being tested?
- Procalcitonin dosage PCT-Q test (Brahms, Germany)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Jun 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 1 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 1-36 months
- With rectal temperature >38.0 C
- And no identified source of infection after history and physical examination
Who cannot join
- acquired or congenital immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
Serious bacterial infections are often difficult to detect in children 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 36 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate
- Conditions
- Procalcitonin, Fever Without Source, Bacterial Infection, Bacteremia
- Being tested
- Procalcitonin dosage PCT-Q test (Brahms, Germany)
- Keywords
- Procalcitonin, Antibiotic, Fever without source, Fever without focus, bacteremia, Urinary tract infection
- Medical subject headings
- Bacterial Infections, Bacteremia, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin dosage PCT-Q test (Brahms, Germany)Other
Also called PCT-Q test (Brahms, Germany)
Procalcitonin result available to the attending physician
| Study group | Role | What they receive |
|---|---|---|
| PCT+ | Experimental | Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm procalcitonin result is revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him Receives: Other: Procalcitonin dosage PCT-Q test (Brahms, Germany) |
| PCT- | No intervention | Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm, procalcitonin is not revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations
Secondary outcomes (2)
Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection)
Procalcitonin sensitivity and specificity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProcalcitoninStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sergio Manzano, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692848
- Sponsor's protocol ID
- URG73
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source
- ClinicalTrials.gov ID
- NCT00692848
- Acronym / sponsor ID
- URG73
- Conditions
- Procalcitonin, Fever Without Source, Bacterial Infection, Bacteremia
- Keywords
- Procalcitonin, Antibiotic, Fever without source, Fever without focus, bacteremia, Urinary tract infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Jun 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.
Serious bacterial infections are often difficult to detect in children 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 36 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT+ | Experimental | Other: Procalcitonin dosage PCT-Q test (Brahms, Germany)Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm procalcitonin result is revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him |
| PCT- | No intervention | –Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm, procalcitonin is not revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him. |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 1-36 months
- With rectal temperature >38.0 C
- And no identified source of infection after history and physical examination
Key exclusion criteria (1 listed)
- acquired or congenital immunodeficiency
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 dosage PCT-Q test (Brahms, Germany)Also: PCT-Q test (Brahms, Germany)Procalcitonin result available to the attending physician | Other | PCT+ |
Primary outcome
Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations
2 secondary outcomes
Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection)
Procalcitonin sensitivity and specificity
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 6 Jun 2008.
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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.
Sergio Manzano, MD principal investigator
St. Justine's Hospital
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 dosage PCT-Q test (Brahms, Germany) in people with Procalcitonin and Fever Without Source, run by St. Justine's Hospital at 1 site in Canada.
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 1 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 6 Jun 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 Canada. 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?
Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations. 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 6 Jun 2008.