Febrile Illness AcuteNCT02313532
Treatment of Febrile Infectious Disease Among Children in Hadera District Given the Final Diagnosis. Descriptive Study
An observational study of Febrile Illness Acute, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 18 years
- Conditions the study is for
- Febrile Illness Acute
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Dec 2015
- 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 7 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Children aged 7 days to 18 years.
- Body temperature that is higher than 37.5°C (Rectal or Oral).
- Informed consent obtained from parents.
Who cannot join
- Children with fever that is longer than 7 days.
- Children diagnosed with immunodeficiency.
- Children that receive chemotherapy.
- Children treated with high dose steroids.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Describing cohort of pediatric patients with acute febrile illness according to anamnesis, physical examination as a clarifying value to the final diagnosis.
- Describing the antibiotic treatment given in the community and its concordance with therapeutic guidelines.
- Describing patients referred to the ED after beginning antibiotic treatment
- Describing patients arrived with sore throat that a diagnostic test for GAS was taken before antibiotic treatment was started.
- Describing the difference between the antibiotic treatment given at the community, the treatment given at the hospital and the concordance to therapeutic guidelines
- 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:
- Final diagnosis of all patients, dividing the diagnosis for viral and bacterial and type of pathogen
- Referral diagnosis, ED diagnosis, pediatric department diagnosis in concordance of the final diagnosis
- The antibiotic treatment according to the referral letter and history and its concordance with therapeutic guidelines.
- Changes or decision to stop antibiotic treatment in the hospital
- 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)
- Conditions
- Febrile Illness Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
pathogen map of febrile illness
Measured: 1 year
Secondary outcomes (1)
antibiotic over use map
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Febrile Illness AcuteStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- or kriger, m.d, Study director, study coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313532
- Sponsor's protocol ID
- 0092-14-HYMC
- Status last verified
- Dec 2014
- First submitted
- 7 Dec 2014
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bergus GR, Levy BT, Levy SM, Slager SL, Kiritsy MC. Antibiotic use during the first 200 days of life. Arch Fam Med. 1996 Oct;5(9):523-6. doi: 10.1001/archfami.5.9.523.
PubMed 8930223Scheifele D, Halperin S, Pelletier L, Talbot J. Invasive pneumococcal infections in Canadian children, 1991-1998: implications for new vaccination strategies. Canadian Paediatric Society/Laboratory Centre for Disease Control Immunization Monitoring Program, Active (IMPACT). Clin Infect Dis. 2000 Jul;31(1):58-64. doi: 10.1086/313923. Epub 2000 Jul 24.
PubMed 10913397Whitney CG, Farley MM, Hadler J, Harrison LH, Lexau C, Reingold A, Lefkowitz L, Cieslak PR, Cetron M, Zell ER, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States. N Engl J Med. 2000 Dec 28;343(26):1917-24. doi: 10.1056/NEJM200012283432603.
PubMed 11136262Seppala H, Nissinen A, Jarvinen H, Huovinen S, Henriksson T, Herva E, Holm SE, Jahkola M, Katila ML, Klaukka T, et al. Resistance to erythromycin in group A streptococci. N Engl J Med. 1992 Jan 30;326(5):292-7. doi: 10.1056/NEJM199201303260503.
PubMed 1728733Ladhani S, Gransden W. Increasing antibiotic resistance among urinary tract isolates. Arch Dis Child. 2003 May;88(5):444-5. doi: 10.1136/adc.88.5.444.
PubMed 12716722Dagan R, Leibovitz E, Greenberg D, Yagupsky P, Fliss DM, Leiberman A. Dynamics of pneumococcal nasopharyngeal colonization during the first days of antibiotic treatment in pediatric patients. Pediatr Infect Dis J. 1998 Oct;17(10):880-5. doi: 10.1097/00006454-199810000-00006.
PubMed 9802628
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Febrile Infectious Disease Among Children in Hadera District Given the Final Diagnosis. Descriptive Study
- ClinicalTrials.gov ID
- NCT02313532
- Acronym / sponsor ID
- 0092-14-HYMC
- Conditions
- Febrile Illness Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Dec 2014 (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.
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:
- Describing cohort of pediatric patients with acute febrile illness according to anamnesis, physical examination as a clarifying value to the final diagnosis.
- Describing the antibiotic treatment given in the community and its concordance with therapeutic guidelines.
- Describing patients referred to the ED after beginning antibiotic treatment
- Describing patients arrived with sore throat that a diagnostic test for GAS was taken before antibiotic treatment was started.
- Describing the difference between the antibiotic treatment given at the community, the treatment given at the hospital and the concordance to therapeutic guidelines
- 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:
- Final diagnosis of all patients, dividing the diagnosis for viral and bacterial and type of pathogen
- Referral diagnosis, ED diagnosis, pediatric department diagnosis in concordance of the final diagnosis
- The antibiotic treatment according to the referral letter and history and its concordance with therapeutic guidelines.
- Changes or decision to stop antibiotic treatment in the hospital
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Children aged 7 days to 18 years.
- Body temperature that is higher than 37.5°C (Rectal or Oral).
- Informed consent obtained from parents.
Key exclusion criteria (4 listed)
- Children with fever that is longer than 7 days.
- Children diagnosed with immunodeficiency.
- Children that receive chemotherapy.
- Children treated with high dose steroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pathogen map of febrile illness
Time frame: 1 year
1 secondary outcome
antibiotic over use map
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Background: PubMed 8930223Bergus GR, Levy BT, Levy SM, Slager SL, Kiritsy MC. Antibiotic use during the first 200 days of life. Arch Fam Med. 1996 Oct;5(9):523-6. doi: 10.1001/archfami.5.9.523.
- Background: PubMed 10913397Scheifele D, Halperin S, Pelletier L, Talbot J. Invasive pneumococcal infections in Canadian children, 1991-1998: implications for new vaccination strategies. Canadian Paediatric Society/Laboratory Centre for Disease Control Immunization Monitoring Program, Active (IMPACT). Clin Infect Dis. 2000 Jul;31(1):58-64. doi: 10.1086/313923. Epub 2000 Jul 24.
- Background: PubMed 11136262Whitney CG, Farley MM, Hadler J, Harrison LH, Lexau C, Reingold A, Lefkowitz L, Cieslak PR, Cetron M, Zell ER, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States. N Engl J Med. 2000 Dec 28;343(26):1917-24. doi: 10.1056/NEJM200012283432603.
- Background: PubMed 1728733Seppala H, Nissinen A, Jarvinen H, Huovinen S, Henriksson T, Herva E, Holm SE, Jahkola M, Katila ML, Klaukka T, et al. Resistance to erythromycin in group A streptococci. N Engl J Med. 1992 Jan 30;326(5):292-7. doi: 10.1056/NEJM199201303260503.
- Background: PubMed 12716722Ladhani S, Gransden W. Increasing antibiotic resistance among urinary tract isolates. Arch Dis Child. 2003 May;88(5):444-5. doi: 10.1136/adc.88.5.444.
- Background: PubMed 9802628Dagan R, Leibovitz E, Greenberg D, Yagupsky P, Fliss DM, Leiberman A. Dynamics of pneumococcal nasopharyngeal colonization during the first days of antibiotic treatment in pediatric patients. Pediatr Infect Dis J. 1998 Oct;17(10):880-5. doi: 10.1097/00006454-199810000-00006.
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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.
or kriger, m.d study director
study coordinator
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 Illness Acute, run by Hillel Yaffe 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 3 inclusion and 4 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 10 Dec 2014. 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 or kriger, m.d (972547860584, orkriger@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathogen map of febrile illness (time frame: 1 year). 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 NCT02313532, which also lists 6 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 10 Dec 2014.