UnknownNot Applicable

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

Israel200 participantsStarted 2016-01

Plain-language 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.

Who can participate

Age range

3 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of febrile children who experienced shivering

Timeframe: Within 7 days from the beginning of fever

Severe bacterial infection

Timeframe: Within 7 days from enrollment

Trial details

NCT IDNCT02760745

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2016-11

Contact for this trial

Eran Kozer, MD

97289779916 erank@asaf.health.gov.il

View on ClinicalTrials.gov More Febrile Shivering trials