NCT04073108

Brief Summary

Definition: fever \< 38˚c for which the cause could not be identified, documented by a health care provider after 3w.evaluation as an outpatient \[or after 1w. evaluation in the hospital\]. Most cases, however, do not have fever alone, but FUO results from atypical presentation of common diseases. On the other hand FUO lasting longer than 6mo is uncommon in children \& suggests granulomatous, autoimmune or auto inflammatory diseases

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

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

August 3, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

August 3, 2019

Last Update Submit

August 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Causes of Fever of unknown origin (FUO) in infants and children attending Assiut University Children Hospital (AUCH)

    investigations

    Baseline

Interventions

tuberculin testDIAGNOSTIC_TEST

tuberclin test used to diagnose tuberculosis as cause of fever of unknown origin

Eligibility Criteria

Age3 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

infants and children

You may qualify if:

  • All FUO cases admitted to AUCH during one year of the study.

You may not qualify if:

  • cases of HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Chien YL, Huang FL, Huang CM, Chen PY. Clinical approach to fever of unknown origin in children. J Microbiol Immunol Infect. 2017 Dec;50(6):893-898. doi: 10.1016/j.jmii.2015.08.007. Epub 2015 Oct 9.

    PMID: 27143687BACKGROUND
  • Attard L, Tadolini M, De Rose DU, Cattalini M. Overview of fever of unknown origin in adult and paediatric patients. Clin Exp Rheumatol. 2018 Jan-Feb;36 Suppl 110(1):10-24. Epub 2018 May 3.

    PMID: 29742054BACKGROUND
  • Antoon JW, Knudson-Johnson M, Lister WM. Diagnostic approach to fever of unknown origin. Clin Pediatr (Phila). 2012 Nov;51(11):1091-4. doi: 10.1177/0009922811431160. Epub 2011 Dec 12. No abstract available.

    PMID: 22166749BACKGROUND
  • Hassan RH, Fouda AE, Kandil SM. Fever of Unknown Origin in Children: A 6 year- Experience in a Tertiary Pediatric Egyptian Hospital. Int J Health Sci (Qassim). 2014 Jan;8(1):13-9. doi: 10.12816/0006067.

    PMID: 24899875BACKGROUND

MeSH Terms

Conditions

Fever of Unknown Origin

Interventions

Tuberculin Test

Condition Hierarchy (Ancestors)

FeverBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Central Study Contacts

Safiea El-Deeb, prof

CONTACT

Mohammed Fathy, Ass.prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2019

First Posted

August 29, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

August 29, 2019

Record last verified: 2019-08