|- candidate number||21391|
|- NTR Number||NTR4949|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jan-2015|
|- Secondary IDs||NL44227.078.13 |
|- Public Title||Higher accuracy and cost-effectiveness using a novel biomarker for Treatment of Emergency Medicine Patients with fever|
|- Scientific Title||Higher accuracy and cost-effectiveness using a novel biomarker for Treatment of Emergency Medicine Patients with fever|
|- hypothesis||PCT is a biomarker that can detect bacterial infections more specific compared to current biomarkers and will result in more accurate antibiotic therapy. Consequently, in cases with other infections (e.g. viral) it will avoid unnecessary antibiotic therapy. Effective antibiotic use will lead to a reduction of antibiotics resistance and costs.
- To investigate efficacy of PCT-guided antibiotic therapy in the ED
- To evaluate the safety of PCT-guided antibiotic therapy in the ED
- To study if PCT-guided therapy is cost-effective
- To investigate the accuracy of PCT as biomarker for bacterial infection
|- Healt Condition(s) or Problem(s) studied||Procalcitonin, Emergency department, Bacterial, Antibiotics|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Fever: ear temperature> 38.1 0C
• Signed informed consent
• Aged 18 years or older
|- Exclusion criteria||A potential eligible subject who meets any of the following criteria will be excluded from participation in this study:
• Immunocompromised patients (neutropenia, defined as an absolute neutrophil count less than 0.5x109/L, current chemotherapy, transplantation patients).
• Predetermined illness with an expected death within 24 hours.
• Surgical fever, defined as fever within 72 hours post-surgery, or patients with a primary surgical diagnosis.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||18-aug-2014|
|- planned closingdate||27-jan-2017|
|- Target number of participants||550|
|- Interventions||For the primary objective ‘efficacy’ the study is set up a superiority study, in which the new intervention is compared to the current standard-of-care.
For the primary objective ‘safety’ the study is set up as a noninferiority study to investigate whether the new intervention (PCT-guided therapy) is at least as safe as the established intervention.
Intervention: Patients will be allocated into two groups:
1. A control group (standard-of-care)
2. Intervention group (PCT-guided therapy)
|- Primary outcome||•Number of febrile patients who are prescribed antibiotics in the ED
•Safety of PCT-guided therapy, defined as 30 days mortality, Intensive Care Unit (ICU) admittance, or a return visit to the ED within 14 days.
• Accuracy of PCT and CRP as area under curve (AUC) compared with diagnosis of bacterial or viral infection by culture, polymerase chain reaction (PCR) and serology
|- Secondary outcome||•Hospital treatment costs (Costs of PCT testing (treatment group only), antibiotics, and other related medical consumption during admittance).
•Related medical consumption during follow-up. (General practitioner (GP) and additional hospital visits, diagnostics and medication)
•Days absence from work and reduced productivity while at work. (if applicable)
•Costs of hospital stay (hospitalized patients) or ICU stay (critically ill patients).
•Costs of extramural antimicrobial therapy.
|- Timepoints||Inclusion will be two years|
|- Trial web site||-|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD Yuri van der Does|
|- CONTACT for SCIENTIFIC QUERIES||MD Yuri van der Does|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Publications||Procalcitonin guided antibiotic therapy in patients presenting with fever in the emergency department.
Limper M, van der Does Y, Brandjes DP, De Kruif MD, Rood PP, van Gorp EC.
J Infect. 2014 Oct;69(4):410-2
|- Brief summary||The implementation of PCT testing could help in achieving early diagnosis and adequate management of febrile patients with infectious diseases in the emergency department.|
|- Main changes (audit trail)|
|- RECORD||8-jan-2015 - 6-aug-2017|