Fever and Shivering: Frequency and Role in Predicting Serious Bacterial Infection

• Conditions: Severe Bacterial Infection; Febrile Shivering
• Interventions: Other: Ancillary tests

• Registration Number: NCT02760745
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-05-01
• Study First Posted: 2016-05-04
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Last Update Submitted: 2016-11-13
• Last Update Posted: 2016-11-15
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• fever at least during the last day
• shivering during current febrile illness
• no shivering during current febrile illness if recruited to the control group

Exclusion Criteria

(for cases and controls)

• immune deficiency
• antibiotics treatment up to 48 hours before the presentation
• presentation following febrile convulsion
• non Hebrew speaking guardians

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Febrile Shivering	Ancillary tests	-
Fever without Shivering	Ancillary tests	-

Primary Outcome Measures

Name	Time	Method
Severe bacterial infection	Within 7 days from enrollment	positive blood cultures (not including common skin pathogens / contaminants), Positive urine culture, Positive csf culture, Alveolar Infiltrate on CXR, positive joint fluid culture.; The number of patients who had at least one positive result in the above mentioned parameters.
Proportion of febrile children who experienced shivering	Within 7 days from the beginning of fever	Proportion of febrile children who experienced shivering

Secondary Outcome Measures

Name	Time	Method
Antibiotics Treatment	Within 24 hours of enrollment	number of patients treated with antibiotics
High inflammatory markers	Within 24 hours of enrollment	The number of patients who had CRP higher than twice the normal range or WBC higher than 15,000.
hospitalization	Within 24 hours of enrollment	number of patients admitted to the hospital

Trial Locations

Locations (1)

Assaf Harofeh MC; 🇮🇱 Zerifin, Israel