SepsisNCT00926497

Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis

A study testing Procalcitonin-guided decision making in people with Sepsis, run by Luzerner Kantonsspital at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success. Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis. Read more about this study

Who is it for?: Ages Up to 3 days
Conditions the study is for: Sepsis
What is being tested?: Procalcitonin-guided decision making
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteSwitzerland
Study dates: Jun 2005to Jan 2007
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 3 days
All sexes
No healthy volunteers
Child

Who may be able to join

Term and near-term infants with a gestational age of more than 34 weeks
Admitted to the Children's Hospital of Lucerne, Switzerland
Suspected neonatal early-onset sepsis
Antibiotic therapy
Parental consent

Who cannot join

Surgery in the first 3 days of life
Severe congenital malformations
Chromosomal abnormalities

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

children's Hospital of Lucerne
Lucerne, 6000

Other trials in Switzerland

About this study

Official title: Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial

Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.

Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.

Read the detailed description

This single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric intensive care unit in the Children's Hospital of Lucerne, Switzerland between June 1, 2005 and December 31, 2006. All term and near term infants with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to Procalcitonin-guided treatment (Procalcitonin-group). Minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the Procalcitonin group antibiotic therapy was discontinued when two consecutive Procalcitonin values were below predefined age-adjusted cut-off values.

Conditions: Sepsis
Being tested: Procalcitonin-guided decision making
Keywords: antibiotic therapy, early-onset sepsis, interventions study, procalcitonin, term and near-term neonates
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Procalcitonin-guided decision makingOther
Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis

Study groups in NCT00926497
Study group	Role	What they receive
Procalcitonin group	Experimental	Antibiotic therapy is discontinued when two consecutive Procalcitonin values are below predefined age-adjusted cut-off values. Antibiotic therapy could be prolonged despite fulfilled Procalcitonin criteria at the discretion of the attending physician. Receives: Other: Procalcitonin-guided decision making
Standard group	No intervention	Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters

What is being measured

The primary outcome is the main question the study is designed to answer.

Antibiotic Treatment for More Than 72 Hours
Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
Measured: 1 month
Absolute Duration of Antibiotic Therapy
Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Jan 2007

First posted23 Jun 2009 (estimated)
Study startJun 2005
Primary completionDec 2006
Study completionJan 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00926497
Sponsor's protocol ID: PCTStocker
Status last verified: May 2009
First submitted: 16 Jan 2009
Last updated: 23 Jun 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial
ClinicalTrials.gov ID: NCT00926497
Acronym / sponsor ID: PCTStocker
Conditions: Sepsis
Keywords: antibiotic therapy, early-onset sepsis, interventions study, procalcitonin, term and near-term neonates
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Luzerner KantonsspitalUniversity, hospital or other
Study start: Jun 2005
Primary completion: Dec 2006 (actual)
Study completion: Jan 2007 (actual)
First posted: 23 Jun 2009 (estimated)
Results: Posted 23 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.

Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Procalcitonin group	Experimental	Other: Procalcitonin-guided decision makingAntibiotic therapy is discontinued when two consecutive Procalcitonin values are below predefined age-adjusted cut-off values. Antibiotic therapy could be prolonged despite fulfilled Procalcitonin criteria at the discretion of the attending physician.
Standard group	No intervention	–Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters

Who may qualify

Ages: Up to 3 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Term and near-term infants with a gestational age of more than 34 weeks
Admitted to the Children's Hospital of Lucerne, Switzerland
Suspected neonatal early-onset sepsis
Antibiotic therapy
Parental consent

Key exclusion criteria (3 listed)

Surgery in the first 3 days of life
Severe congenital malformations
Chromosomal abnormalities

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 decision makingProcalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis	Other	Procalcitonin group

Primary outcome

Antibiotic Treatment for More Than 72 Hours
Time frame: 1 month
Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
Absolute Duration of Antibiotic Therapy
Time frame: 1 month
Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)

Results and safety

Results posted to the registry on 23 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Procalcitonin-group	60	60
Standard Group	61	61

Primary outcome: Antibiotic Treatment for More Than 72 Hours

Time frame: 1 month. Number. Unit: participants

Measure	Procalcitonin-group n = 60	Standard Group n = 61
Value	33	55

Procalcitonin-group vs Standard Group: p = 0.002, Fisher Exact

Primary outcome: Absolute Duration of Antibiotic Therapy

Time frame: 1 month. Mean (Full Range). Unit: hours

Measure	Procalcitonin-group n = 60	Standard Group n = 61
Value	79.1 (24 to 190)	101.5 (38 to 196)

Procalcitonin-group vs Standard Group: p = 0.012, t-test, 2 sided
Procalcitonin-group vs Standard Group: p = 0.004, Wilcoxon (Mann-Whitney)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Procalcitonin-group	0 of ?	1 of ?	Not reported
Standard Group	0 of ?	0 of ?	Not reported

Limitations and caveats (from the sponsor): The samll sample size does not allow to prove the safety of our Procalcitonin-guided strategy. Second, because of our single center setting, our results cannot be easily be extrapolated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

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.

Martin Stocker, MD principal investigator

Children's Hospital Lucerne, Switzerland

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 decision making in people with Sepsis, run by Luzerner Kantonsspital 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 5 inclusion and 3 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 23 Jun 2009. 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?

Yes. Results are posted in the registry (first posted 23 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 for More Than 72 Hours (time frame: 1 month). 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 NCT00926497.

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 23 Jun 2009.