Primary:- To investigate efficacy of PCT-guided antibiotic therapy in the ED- To evaluate the safety of PCT-guided antibiotic therapy in the ED - To determine and compare the accuracy of PCT and CRP as biomarker for bacterial infectionSecondary:- To…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Number of febrile patients who are prescribed antibiotics in the ED
* A composite endpoint for 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 the
diagnosis of 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).
* Costs of length of hospital stay (hospitalized patients) or length of ICU
stay (critically ill patients).
* 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 extramural type and duration of antimicrobial therapy.
Background summary
Background: Infectious diseases are an important problem for patients
presenting to the emergency department (ED). Timely diagnostic-therapeutic
decisions are crucial in many cases and it will have a repercussion in survival
of patients with severe bacterial infections. However, clinical features in
infectious diseases are often nonspecific, which make early recognition and
implementation of adequate therapy difficult. There are several biomarkers of
infection that have been investigated in recent years. One of these markers,
procalcitonin (PCT), has a good diagnostic utility. The implementation of PCT
testing could help tremendously in achieving early diagnosis and adequate
management of febrile patients with infectious diseases in the ED.
Rationale: 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. This may lead to a reduction of
antibiotics resistance and costs.
Study objective
Primary:
- To investigate efficacy of PCT-guided antibiotic therapy in the ED
- To evaluate the safety of PCT-guided antibiotic therapy in the ED
- To determine and compare the accuracy of PCT and CRP as biomarker for
bacterial infection
Secondary:
- To study if PCT-guided therapy is cost-effective
Study design
Multi center randomized study. 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. The
primary objective 'accuracy' is designed as a superiority study, where the
accuracy of biomarkers in the diagnosis of bacterial infection is determined
and compared using an AUC.
Intervention
Patients will be allocated into two groups:
1. A control group (standard-of-care)
2. Intervention group (PCT-guided therapy)
Study burden and risks
This trial is considered a intermediate risk trial as it follows the
international surviving sepsis campaign guidelines for PCT- guided therapy.
This trial is supported by results of earlier research performed with PCT, in
which PCT-guided therapy has shown to be safe in febrile patients. Recent
meta-analyses found no increased risk or rate of treatment failure when
PCT-guided therapy was used in patients with acute respiratory infections, and
found a significant reduction in antibiotic usage across all clinical settings.
The expected benefits are that the implementation of PCT-guided therapy should
help in application of adequate (antibiotic) therapy. It will prevent
unnecessary antibiotic therapy, which reduces bacterial antibiotic resistance.
It will also help in reducing medical costs and the risk of drug related
adverse effects.
Furthermore, this study respects physician judgement. In case the physician
decides that antibiotics are required, even though the study protocol advises
otherwise, this treatment can be initiated regardless of PCT levels.
Dr. Molewaterplein 30
Rotterdam 3015GD
NL
Dr. Molewaterplein 30
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
fever
Exclusion criteria
under 18 years of age. Pregnant patients. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL44227.078.13 |
| OMON | NL-OMON25141 |