The aim of this study is to establish the accuracy of Molecular Culture for prediciting the outcome of the traditional blood culture.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic accuracy of the Molecular Culture technique for predicting the
outcome of the current conventional blood culture
Secondary outcome
The diagnostic accuracy of the Molecular Culture and of the current
conventional blood culture for clinical sepsis, which will be defined in
various ways.
Diagnostic accuracy of the molecular culture on blood sampled <72 hours post
initiation of antibiotics to assess detectibility of bacteria in presence of
antibiotics
Background summary
Babies and children have an increased risk of getting an infection with a
bacteria in the bloodstream (sepsis). It is often difficult for the doctor to
determine whether a child has an infection of the bloodstream, because the
symptoms are often unclear and can also occur in children who are not sick. To
determine whether there is an infection, a little blood is currently taken for
a blood test (theblood culture) to investigate whether there is a bacteria in
the blood. However, it often takes at least 36 hours before the results ofthis
blood culture are available. That is why antibiotics are usually started
immediately to treat the possible infection.
However, it often turns out that the blood culture is negative after 36 hours,
which means that no bacteria have been found in theblood. Usually the
antibiotics are then stopped because it turns out that there was no infection
at all. There is currently no good test that can predict whether (newborn)
children have an infection or not. That is why too many children are currently
wrongly receiving antibiotics. These antibiotics can damage the healthy
bacteria in the intestines. There are many billions of 'beneficial bacteria' in
theintestine. These play an important role in the digestion of food and protect
against external infections. Antibiotics aim to kill bacteriathat cause
inflammation or infection. Unfortunately, antibiotics also kill some of these
beneficial bacteria. In addition, unnecessaryuse of antibiotics contributes to
antibiotic resistance. The aim of this research is to investigate whether
Molecular Culture, a PCR based test that can identify bacterial pathogens in
bodily fluids within 4 hours, has greater accuracy than traditional culturing
techniques for bacteria in blood. If proven, this could lead to faster
identification or exclusion of sepsis in children.
Study objective
The aim of this study is to establish the accuracy of Molecular Culture for
prediciting the outcome of the traditional blood culture.
Study design
Multicenter, prospective, observational cohort study
Study burden and risks
There is no/minimal extra burden for participants. One or several extra tubes
of blood will be sampled during a regular blood sampling for thisstudy.
There will be no direct benefits for participants, but future patients might
benefit from this technique.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
• Undergoing collection of blood for a conventional blood culture for standard
care
OR
Having undergone collection of blood for conventional blood culture for
standard care in the past 72 hours
AND
Informed consent
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84592.018.23 |