Severe Bacterial Infection Clinical Trial
Official title:
Fever and Shivering: Frequency Among Children Visiting the Emergency Department and Its Role in Predicting Serious Bacterial Infection
Febrile shivering in the pediatric population is assumed to be related to a Severe Bacterial Infection (SBI). Research supporting this assumption is scant. The purpose of this study is to describe the frequency of febrile shivering in the pediatric population arriving at the emergency department and to define its role in predicting a SBI.
Background: Fever is a common complaint and lacking localizing signs poses a diagnostic
dilemma, mostly, but not only, in children under 3 years of age. Recent years studies found
common clinical markers for a Serious Bacterial Infection (SBI) to be ineffective in
confirming or ruling out a suspected SBI in an environment with low prevalence of SBI such
as developed countries. Shivering (chills, rigors) during a febrile illness is a common
complaint in children but it's true incidence is unknown. It is assumed that shivering
appears more frequently in children with SBI but only one study in the pediatric population
was found to support this assumption. No studies were found to describe the frequency of
shivering in the emergency department. Study purpose: To describe the frequency of febrile
shivering in the pediatric population arriving at the emergency department and it's relation
to a Severe Bacterial Infection. Participants: Children in the age range of 3 months to 18
years presenting with fever. Intervention: During the study time frame the frequency of
febrile shivering will be documented . Patients with febrile shivering who meet the
inclusion criteria, a sepsis workup will be done including blood samples for inflammatory
markers, blood culture, urinalysis and urine culture when a urinary tact infection is
suspected. Other systems (CSF sampling, joint fluid aspiration, stool culture, chest x ray)
will be examined according to an appropriate history and clinical suspicion. The same work
up will be done in next consecutive patient presenting with fever without shivering.
Results: The frequency of febrile shivering, positive cultures, lobar pneumonia in a chest x
ray. A comparison between the study and the control group will be made. Categorical
variables will be compared using the Chi square test or Fisher exact test (as appropriate).
Continuous variables will be compared using the student t test or Mann Whitney test. The
relation between a bacterial infection and clinical variables will be analyzed using a
logistic regression. Study group size: This is a pilot study. Investigators will use a
convenience sample of all children admitted with shivering during the study period.
Safety: All examinations will be held by the emergency department organic staff in the same
routine methods done otherwise outside the study settings. The emergency department and
hospital protocols for patients identification and infection control will be carried out
before invasive procedures. Ethics: Parents will be asked for their agreement to answer a
questioner as part of the study and their agreement will be documented. Informed consent
will be asked for each patient, of the legal guardian. The study will be held according to
the ethics rules of the Helsinki declaration and was approved by the local Ethics board.
Access to the database will be restricted to the study investigators. The database will be
encrypted by a password. After gathering the data and before statistical analysis
information identifying the patients will be removed. The importance of the study: Fever in
children is a common complaint frequently posing a dilemma on the extent of workup needed
beyond clinical evaluation. This study aims to examine the frequency of shivering among
children presenting to the ED with fever , its ability to predict the risk of severe
bacterial infection.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03225079 -
PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring
|