NCT02313532

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

December 7, 2014

Last Update Submit

December 7, 2014

Conditions

Febrile Illness Acute

Outcome Measures

Primary Outcomes (1)

  • pathogen map of febrile illness

    1 year

Secondary Outcomes (1)

  • antibiotic over use map

    1 year

Eligibility Criteria

Age7 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Children with fever that is longer than 7 days.
  • Children diagnosed with immunodeficiency.
  • Children that receive chemotherapy.
  • Children treated with high dose steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe MC,

Hadera, Israel

Location

Related Publications (6)

  • 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.

    PMID: 8930223BACKGROUND

  • Scheifele 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.

    PMID: 10913397BACKGROUND

  • Whitney 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.

    PMID: 11136262BACKGROUND

  • Seppala 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.

    PMID: 1728733BACKGROUND

  • Ladhani 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.

    PMID: 12716722BACKGROUND

  • Dagan 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.

    PMID: 9802628BACKGROUND

Study Officials

  • or kriger, m.d

    study coordinator

    STUDY DIRECTOR

Central Study Contacts

or kriger, m.d

CONTACT

972547860584orkriger@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 10, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

IL(1)