Clinical trial NCT02313532: Treatment of Febrile Infectious Disease Among Children in Hadera District Given the Final Diagnosis. Descriptive Study
Official title: Treatment of Febrile Infectious Disease Among Children in Hadera District Given the Final Diagnosis. Descriptive Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Febrile Illness Acute
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-12-10
Enrollment: 500
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Research population A sum of 500 patients recruited to the "curiosity" study in Hillel-yaffe hospital

Inclusion criteria:

1. Children aged 7 days to 18 years.
2. Body temperature that is higher than 37.5°C (Rectal or Oral).
3. Informed consent obtained from parents.

Exclusion criteria:

1. Children with fever that is longer than 7 days.
2. Children diagnosed with immunodeficiency.
3. Children that receive chemotherapy.
4. Children treated with high dose steroids.

Brief summary: Study goal - to describe pediatric patients with febrile disease that administered to the emergency department (ED) of hillel-yaffe hospital, according to arrival diagnosis, ED diagnosis, given therapy, and therapy concordance with the guidelines and final diagnosis.

This research will describe cases that arrived to the hospital with acute febrile disease (up to seven days of fever), the antibiotic treatment given in the community according to the anamnesis and the community physician letter, therapy concordance with the guidelines, the ED diagnosis and changes in therapy, and final diagnosis according to extended microbiological examinations and panel of infectious disease specialists.

Detailed description: Major goal:

To describe cases that arrived to the pediatric ED with acute febrile illness (up to 7 days of fever) and the final diagnosis they received. To describe the antibiotic treatment given in the community as described in the anamnesis and referral letter, the concordance of the treatment to the therapeutic guidelines, the diagnosis given in the ED and the change in Antibiotic treatment, and the final diagnosis given after extended microbiologic tests were taken from a panel of infectious diseases specialists.

Minor goals:

1. Describing cohort of pediatric patients with acute febrile illness according to anamnesis, physical examination as a clarifying value to the final diagnosis.
2. Describing the antibiotic treatment given in the community and its concordance with therapeutic guidelines.
3. Describing patients referred to the ED after beginning antibiotic treatment
4. Describing patients arrived with sore throat that a diagnostic test for GAS was taken before antibiotic treatment was started.
5. Describing the difference between the antibiotic treatment given at the community, the treatment given at the hospital and the concordance to therapeutic guidelines
6. Describing the concordance between community diagnosis, in hospital diagnosis and the final diagnosis

Study assumption:

To create a map of infectious agents for children presenting with febrile illness, to decide which antibiotic prescribed was correct according to the final diagnosis. We assume that many of the given antibiotic treatments were incorrect to the final diagnosis.

Methodology:

Background:

Ruling out diagnosis of acute febrile illness in the ED is usually done relying on history, physical examination, routine laboratory tests (complete blood count, CRP, pro-calcitonin, urine dipstick), cultures (blood, urine. CSF, stool, throat culture etc.), imaging studies (Chest X-ray, ultra-sonography etc.) and other tests (lumbar puncture, serology, PCR etc.). the study:" Validation of markers for diagnosing the source of infection in pediatric febrile patient" number 0071-10-HYMC ("curiosity" study, see appendix A) is a prospective trial started in 2010 set in Hillel-yaffe hospital in Hadera, Israel. In this study patients with up to seven days of febrile illness, are recruited from the ED or pediatric department, history is taken that includes the home given therapy, blood tests are taken for complete blood count (CBC), culture and C-reactive peptide (CRP), imaging examinations are taken according to each case, PCR and Serology tests are taken to discern between number of agents (appendix A) and the final diagnosis is decided by a panel of infectious diseases specialists.

Research Method

Using "curiosity" study database for patients that recruited from the ED or pediatric department in Hillel-yaffe hospital. Usage of database will give the next data:

1. Final diagnosis of all patients, dividing the diagnosis for viral and bacterial and type of pathogen
2. Referral diagnosis, ED diagnosis, pediatric department diagnosis in concordance of the final diagnosis
3. The antibiotic treatment according to the referral letter and history and its concordance with therapeutic guidelines.
4. Changes or decision to stop antibiotic treatment in the hospital
5. Weather antibiotic therapy started at the community might interfere with making the right diagnosis (for example - antibiotic treatment started before urine culture was taken, GAS culture and rapid test taken)

Eligibility criteria: Inclusion Criteria:

1. Children aged 7 days to 18 years.
2. Body temperature that is higher than 37.5°C (Rectal or Oral).
3. Informed consent obtained from parents.

Exclusion Criteria:

1. Children with fever that is longer than 7 days.
2. Children diagnosed with immunodeficiency.
3. Children that receive chemotherapy.
4. Children treated with high dose steroids.

Primary outcomes:
measure: pathogen map of febrile illness
timeFrame: 1 year
Secondary outcomes:
measure: antibiotic over use map
timeFrame: 1 year
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe MC,
Study officials:
affiliation: study coordinator
name: or kriger, m.d
role: STUDY_DIRECTOR
References:
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