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

NCT02760745 | Unknown

• 1 other identifier: ASF-0207-15
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Shivering; Severe Bacterial Infection

Keywords

fever; shivering; chills; rigors; severe bacterial infection

Outcome Measures

Primary Outcomes (2)

• Proportion of febrile children who experienced shivering

  Proportion of febrile children who experienced shivering

  Within 7 days from the beginning of fever

• Severe bacterial infection

  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.

  Within 7 days from enrollment

Secondary Outcomes (3)

• High inflammatory markers

  Within 24 hours of enrollment

• Antibiotics Treatment

  Within 24 hours of enrollment

• hospitalization

  Within 24 hours of enrollment

Study Arms (2)

Febrile Shivering

Other: Ancillary tests

Fever without Shivering

Other: Ancillary tests

Interventions

Ancillary tests OTHER

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

Febrile Shivering; Fever without Shivering

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients arriving at the pediatric emergency department with fever

You may qualify if:

• fever at least during the last day
• shivering during current febrile illness

You may not qualify if:

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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh MC

Ẕerifin, 70300, Israel

RECRUITING

Related Publications (8)

• Baraff LJ. Management of infants and young children with fever without source. Pediatr Ann. 2008 Oct;37(10):673-9. doi: 10.3928/00904481-20081001-01.

  PMID: 18972849 BACKGROUND

• McCarthy PL, Sharpe MR, Spiesel SZ, Dolan TF, Forsyth BW, DeWitt TG, Fink HD, Baron MA, Cicchetti DV. Observation scales to identify serious illness in febrile children. Pediatrics. 1982 Nov;70(5):802-9. No abstract available.

  PMID: 7133831 BACKGROUND

• Brauner M, Goldman M, Kozer E. Extreme leucocytosis and the risk of serious bacterial infections in febrile children. Arch Dis Child. 2010 Mar;95(3):209-12. doi: 10.1136/adc.2009.170969.

  PMID: 20308337 BACKGROUND

• Van den Bruel A, Haj-Hassan T, Thompson M, Buntinx F, Mant D; European Research Network on Recognising Serious Infection investigators. Diagnostic value of clinical features at presentation to identify serious infection in children in developed countries: a systematic review. Lancet. 2010 Mar 6;375(9717):834-45. doi: 10.1016/S0140-6736(09)62000-6. Epub 2010 Feb 2.

  PMID: 20132979 BACKGROUND

• Craig JC, Williams GJ, Jones M, Codarini M, Macaskill P, Hayen A, Irwig L, Fitzgerald DA, Isaacs D, McCaskill M. The accuracy of clinical symptoms and signs for the diagnosis of serious bacterial infection in young febrile children: prospective cohort study of 15 781 febrile illnesses. BMJ. 2010 Apr 20;340:c1594. doi: 10.1136/bmj.c1594.

  PMID: 20406860 BACKGROUND

• Richardson M, Lakhanpaul M; Guideline Development Group and the Technical Team. Assessment and initial management of feverish illness in children younger than 5 years: summary of NICE guidance. BMJ. 2007 Jun 2;334(7604):1163-4. doi: 10.1136/bmj.39218.495255.AE. No abstract available.

  PMID: 17540946 BACKGROUND

• Tal Y, Even L, Kugelman A, Hardoff D, Srugo I, Jaffe M. The clinical significance of rigors in febrile children. Eur J Pediatr. 1997 Jun;156(6):457-9. doi: 10.1007/s004310050638.

  PMID: 9208242 BACKGROUND

• Lee CC, Wu CJ, Chi CH, Lee NY, Chen PL, Lee HC, Chang CM, Ko NY, Ko WC. Prediction of community-onset bacteremia among febrile adults visiting an emergency department: rigor matters. Diagn Microbiol Infect Dis. 2012 Jun;73(2):168-73. doi: 10.1016/j.diagmicrobio.2012.02.009. Epub 2012 Mar 29.

  PMID: 22463870 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine, stool, csf, throat culture, joint fluid

MeSH Terms

Conditions

Bacterial Infections; Fever; Chills

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eran Kozer, MD

CONTACT

97289779916; erank@asaf.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Pediatric Emergency Unit

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: May 4, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

IL (1)