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Trial record 38 of 247 for:    Recruiting, Not yet recruiting, Available Studies | "Fever"

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

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ClinicalTrials.gov Identifier: NCT02760745
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, 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.

Condition or disease Intervention/treatment
Febrile Shivering Severe Bacterial Infection Other: Ancillary tests

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 Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Fever and Shivering: Frequency Among Children Visiting the Emergency Department and Its Role in Predicting Serious Bacterial Infection
Study Start Date : January 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Febrile Shivering Other: Ancillary tests
Blood culture, complete blood count, crp, urinalysis for all patients. If clinically indicated: Urine culture, chest x ray, csf culture, stool culture, joint fluid culture
Fever without Shivering Other: Ancillary tests
Blood culture, complete blood count, crp, urinalysis for all patients. If clinically indicated: Urine culture, chest x ray, csf culture, stool culture, joint fluid culture



Primary Outcome Measures :
  1. Proportion of febrile children who experienced shivering [ Time Frame: Within 7 days from the beginning of fever ]
    Proportion of febrile children who experienced shivering

  2. Severe bacterial infection [ Time Frame: 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.



Secondary Outcome Measures :
  1. High inflammatory markers [ Time Frame: Within 24 hours of enrollment ]
    The number of patients who had CRP higher than twice the normal range or WBC higher than 15,000.

  2. Antibiotics Treatment [ Time Frame: Within 24 hours of enrollment ]
    number of patients treated with antibiotics

  3. hospitalization [ Time Frame: Within 24 hours of enrollment ]
    number of patients admitted to the hospital


Biospecimen Retention:   Samples Without DNA
blood, urine, stool, csf, throat culture, joint fluid


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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients arriving at the pediatric emergency department with fever
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760745


Contacts
Contact: Eran Kozer, MD 97289779916 erank@asaf.health.gov.il

Locations
Israel
Assaf Harofeh MC Recruiting
Zerifin, Israel, 70300
Contact: yair Erell, MD    97289779913    yairerell@gmail.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Publications:

Responsible Party: Assaf Harofeh MC, Director Pediatric Emergency Unit, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02760745     History of Changes
Other Study ID Numbers: ASF-0207-15
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:
fever
shivering
chills
rigors
severe bacterial infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections