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Neonatal Procalcitonin Intervention Study

2014-08-27 03:23:54 | BioPortfolio

Summary

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.

Description

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%.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Sepsis

Intervention

Procalcitonin-guided decision making

Location

children's Hospital of Lucerne
Lucerne
Switzerland
6000

Status

Recruiting

Source

Luzerner Kantonsspital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:23:54-0400

Clinical Trials [2112 Associated Clinical Trials listed on BioPortfolio]

A Clinical Trial of Procalcitonin-guided Antimicrobial Therapy in Sepsis

The aim of the study is to demonstrate if using one procalcitonin (PCT)-guided rule of stop of antimicrobials, the incidence of infections by C.difficile and by Multi-Drug-Resistant (MDR) ...

Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

The adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these p...

Improve Management of Heart Failure With Procalcitonin

Patients presenting to the Emergency Department with shortness of breath and (suspected) heart failure will be screened and randomized to either a standard of care or a procalcitonin-guide...

Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis

Severe sepsis and septic shock are diseases of infectious origin with a high risk of death. The purpose of this study is to determine whether the intravenous application of selenium (given...

Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis

Procalcitonin is a promising marker of sepsis in critically ill patients. Procalcitonin have better diagnostic accuracy compared to White blood cell count and C - reactive protein. Investi...

PubMed Articles [6282 Associated PubMed Articles listed on BioPortfolio]

The cost impact of PCT-guided antibiotic stewardship versus usual care for hospitalised patients with suspected sepsis or lower respiratory tract infections in the US: A health economic model analysis.

Procalcitonin is a biomarker that supports clinical decision-making on when to initiate and discontinue antibiotic therapy. Several cost (-effectiveness) analyses have been conducted on Procalcitonin-...

The use of procalcitonin in the determination of severity of sepsis, patient outcomes and infection characteristics.

The primary objective of this study was to determine the correlation between procalcitonin values and illness severity by evaluating the degree of end organ dysfunction using the Sequential Organ Fail...

Overview of procalcitonin in pregnancy and in pre-eclampsia.

Procalcitonin (PCT), a precursor for calcitonin, is a pro-hormone involved in the inflammatory processes, which has been poorly studied in the context of pregnancy. During severe inflammation, PCT der...

Procalcitonin-Guided Antibiotic Discontinuation and Mortality in Critically Ill Adults: A Systematic Review and Meta-Analysis.

Procalcitonin (PCT)-guided antibiotic discontinuation appears to decrease antibiotic use in critically ill patients, but its impact on survival remains less certain.

Role of Procalcitonin as a Sepsis Marker.

Adequate diagnosis and therapy of sepsis is of major prognostic relevance. Besides the gold standard (blood culture diagnostics) biomarkers, e.g. serum procalcitonin (PCT), are clinically increasingly...

Medical and Biotech [MESH] Definitions

Mathematical or statistical procedures used as aids in making a decision. They are frequently used in medical decision-making.

Use of an interactive computer system designed to assist the physician or other health professional in choosing between certain relationships or variables for the purpose of making a diagnostic or therapeutic decision.

A scenario in decision analysis in which two individuals motivated entirely by self-preservation at the expense of the other, end up in a worse state than if they had cooperated with each other in the decision-making process.

The process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables, and usually defining a course of action or an idea.

Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.

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