Neonatal Procalcitonin Intervention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. The investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal early-onset sepsis with unchanged outcome. This study is designed as a multi-center, prospective, randomized intervention trial. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the probability of infection during hospitalisation. In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00926497

Sepsis

COMPLETED NA

PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS

NCT05796115

Early-Onset Neonatal Sepsis

UNKNOWN NA

Procalcitonin in Diagnosis of Bacterial Infections in Young Infants

NCT03509727

Sepsis

COMPLETED

Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)

NCT02567305

Sepsis

UNKNOWN

Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy

NCT05350813

Bacterial Infections

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Detailed description according our pilot study (see reference). This trial is designed to exclude a difference in rate of re-infection or death greater than 2%. Assuming a 2% reinfection/death rate in each group, 770 patients are required for a power of 80% at alpha=0.05. To allow for some unevaluable cases 800 per group will be included. Based on the data of the pilot study (see reference), with a number of 770 per group a difference between mean antibiotic therapy durations of 10 hours can be detected at two-sided alpha of 0.05 with a power of 95%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PCT group

In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.Antibiotic therapy can be continued despite fulfilled criteria at the discretion of the attending physician. These divesions from the stopping rules will be reported for further analysis.

Group Type EXPERIMENTAL

Procalcitonin-guided decision making

Intervention Type OTHER

In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PDT values are within the normal range.

Standard group

The duration of antibiotic treatment in the standard group is based on the attending physician's assessment of the risk of classification: infection unlikely for 36-72 hours, infection possible for 5-7 days, infection probable of proven for 7-21 days depending on clinical course, laboratory values and positive cultures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Procalcitonin-guided decision making

In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PDT values are within the normal range.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Procalcitonin-guided duration of antibiotic therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Term and near term infants with a gestational age \> 34 weeks
* Suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy
* Parental consent