Febrile ShiveringNCT02760745
Fever and Shivering: Frequency and Role in Predicting Serious Bacterial Infection
An observational study of Febrile Shivering and Severe Bacterial Infection, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Febrile Shivering, Severe Bacterial Infection
- What is being tested?
- Ancillary tests
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients arriving at the pediatric emergency department with fever
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh MC
Tsrifin, 70300
yair Erell, MD, 97289779913, yairerell@gmail.com
About this study
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.
Read the 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.
- Conditions
- Febrile Shivering, Severe Bacterial Infection
- Being tested
- Ancillary tests
- Keywords
- fever, shivering, chills, rigors, severe bacterial infection
- Medical subject headings
- Bacterial Infections, Fever, Chills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ancillary testsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Febrile Shivering | Not described Receives: Other: Ancillary tests | |
| Fever without Shivering | Not described Receives: Other: Ancillary tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of febrile children who experienced shivering
Proportion of febrile children who experienced shivering
Measured: 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.
Measured: Within 7 days from enrollment
Secondary outcomes (3)
High inflammatory markers
The number of patients who had CRP higher than twice the normal range or WBC higher than 15,000.
Measured: Within 24 hours of enrollment
Antibiotics Treatment
number of patients treated with antibiotics
Measured: Within 24 hours of enrollment
hospitalization
number of patients admitted to the hospital
Measured: Within 24 hours of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Febrile ShiveringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760745
- Sponsor's protocol ID
- ASF-0207-15
- Status last verified
- Nov 2016
- First submitted
- 24 Mar 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18972849McCarthy 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.
PubMed 7133831Brauner 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.
PubMed 20308337Van 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.
PubMed 20132979Craig 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.
PubMed 20406860Richardson 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.
PubMed 17540946Tal 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.
PubMed 9208242Lee 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.
PubMed 22463870
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fever and Shivering: Frequency Among Children Visiting the Emergency Department and Its Role in Predicting Serious Bacterial Infection
- ClinicalTrials.gov ID
- NCT02760745
- Acronym / sponsor ID
- ASF-0207-15
- Conditions
- Febrile Shivering, Severe Bacterial Infection
- Keywords
- fever, shivering, chills, rigors, severe bacterial infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Febrile Shivering | – | Other: Ancillary tests |
| Fever without Shivering | – | Other: Ancillary tests |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients arriving at the pediatric emergency department with fever
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ancillary testsBlood culture, complete blood count, crp, urinalysis for all patients. If clinically indicated: Urine culture, chest x ray, csf culture, stool culture, joint fluid culture | Other | Febrile Shivering, Fever without Shivering |
Primary outcome
Proportion of febrile children who experienced shivering
Time frame: Within 7 days from the beginning of fever
Proportion of febrile children who experienced shivering
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.
3 secondary outcomes
High inflammatory markers
Time frame: Within 24 hours of enrollment
Antibiotics Treatment
Time frame: Within 24 hours of enrollment
hospitalization
Time frame: Within 24 hours of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Background: PubMed 18972849Baraff 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.
- Background: PubMed 7133831McCarthy 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.
- Background: PubMed 20308337Brauner 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.
- Background: PubMed 20132979Van 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.
- Background: PubMed 20406860Craig 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.
- Background: PubMed 17540946Richardson 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.
- Background: PubMed 9208242Tal 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.
- Background: PubMed 22463870Lee 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Shivering and Severe Bacterial Infection, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Kozer, MD (97289779916, erank@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of febrile children who experienced shivering (time frame: Within 7 days from the beginning of fever). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760745, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.