Fever of Unknown OriginNCT04073108
Causes of FUO in Infants and Children
An observational study of Fever of Unknown Origin, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Fever of Unknown Origin
- What is being tested?
- tuberculin test
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2021
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: infants and children
Who may be able to join
- All FUO cases admitted to AUCH during one year of the study.
Who cannot join
- cases of HIV
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Causes of Fever of Unknown Origin (FUO) in Infants and Children Attending Assiut University Children Hospital (AUCH)
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
Read the detailed description
Fever of unknown origin (FUO) is a relatively common pediatric complaint. The time of FUO generally ranges from 10 to 21 days. Generally the fever should be greater than 38.3 ˚c for at least 10 days with no evident source after initial outpatient or inpatient workup. A broad range of illnesses are known to cause FUO, including infectious, autoimmune and oncologic etiologies. Definitive diagnosis of FUO can be challenging, with many cases resolving spontaneously without a diagnosis. There is currently no standardized diagnostic approach for working up FUO. The general direction of the workup often depends on the patient's presentation, symptoms, and environmental exposures. It is generally accepted that a complete history and physical examination as well as basic laboratory tests, and empiric antibiotic therapy are initial steps in the workup of FUO. With no advanced resources available, radiographs such as chest X-rays and abdominal ultrasonography as well as simple tests e.g. ESR are commonly performed looking for infectious and malignant sources of FUO. If the diagnosis is still obscure laboratory tests for auto immune antibodies or specific infectious agents, are additional logical steps if the diagnosis remains in question.
Unlike adult studies, the categorical distribution of diagnosis of the causes of FUO in pediatrics has not changed in recent decades (Nield\&Kamat , 2018) [1]. Additional studies are needed to improve the recognition of causes of prolonged fever in children.
So that FUO is not a single specific medical disorder but may be a potential manifestation of several diseases and disorders. The initial approach to FUO is suggested to be determination of the causes of prolonged fever in each of the body systems, as suggested by the presenting complaint. For instance in the respiratory system in developing countries tuberculosis (TB) must be searched for in the first place. Similarly Protein Energy Malnutrition (PEM), and vitamin D deficiency rickets must be also thought of as a cause of recurrent / chronic chest infection leading to FUO. In the gastrointestinal system persistant/ recurrent diarrhea must be searched for. In the developing countries, urinary tract infection, typhoid fever and viral hepatitis constitute other hidden causes of FUO. Collagen diseases, auto inflammatory diseases as well as immune deficiency diseases and auto immune disorders must be searched for as causes of FUO.
- Conditions
- Fever of Unknown Origin
- Being tested
- tuberculin test
- Medical subject headings
- Fever of Unknown Origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tuberculin testDiagnostic test
tuberclin test used to diagnose tuberculosis as cause of fever of unknown origin
What is being measured
The primary outcome is the main question the study is designed to answer.
Causes of Fever of unknown origin (FUO) in infants and children attending Assiut University Children Hospital (AUCH)
investigations
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fever of Unknown OriginStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Mohammed Abd El Twab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073108
- Sponsor's protocol ID
- cofouoiiacaauch
- Status last verified
- Aug 2019
- First submitted
- 3 Aug 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27143687Attard 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.
PubMed 29742054Antoon 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.
PubMed 22166749Hassan 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.
PubMed 24899875
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Fever of Unknown Origin (FUO) in Infants and Children Attending Assiut University Children Hospital (AUCH)
- ClinicalTrials.gov ID
- NCT04073108
- Acronym / sponsor ID
- cofouoiiacaauch
- Conditions
- Fever of Unknown Origin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 29 Aug 2019 (actual)
- 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.
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
Detailed description
Fever of unknown origin (FUO) is a relatively common pediatric complaint. The time of FUO generally ranges from 10 to 21 days. Generally the fever should be greater than 38.3 ˚c for at least 10 days with no evident source after initial outpatient or inpatient workup. A broad range of illnesses are known to cause FUO, including infectious, autoimmune and oncologic etiologies. Definitive diagnosis of FUO can be challenging, with many cases resolving spontaneously without a diagnosis. There is currently no standardized diagnostic approach for working up FUO. The general direction of the workup often depends on the patient's presentation, symptoms, and environmental exposures. It is generally accepted that a complete history and physical examination as well as basic laboratory tests, and empiric antibiotic therapy are initial steps in the workup of FUO. With no advanced resources available, radiographs such as chest X-rays and abdominal ultrasonography as well as simple tests e.g. ESR are commonly performed looking for infectious and malignant sources of FUO. If the diagnosis is still obscure laboratory tests for auto immune antibodies or specific infectious agents, are additional logical steps if the diagnosis remains in question.
Unlike adult studies, the categorical distribution of diagnosis of the causes of FUO in pediatrics has not changed in recent decades (Nield\&Kamat , 2018) [1]. Additional studies are needed to improve the recognition of causes of prolonged fever in children.
So that FUO is not a single specific medical disorder but may be a potential manifestation of several diseases and disorders. The initial approach to FUO is suggested to be determination of the causes of prolonged fever in each of the body systems, as suggested by the presenting complaint. For instance in the respiratory system in developing countries tuberculosis (TB) must be searched for in the first place. Similarly Protein Energy Malnutrition (PEM), and vitamin D deficiency rickets must be also thought of as a cause of recurrent / chronic chest infection leading to FUO. In the gastrointestinal system persistant/ recurrent diarrhea must be searched for. In the developing countries, urinary tract infection, typhoid fever and viral hepatitis constitute other hidden causes of FUO. Collagen diseases, auto inflammatory diseases as well as immune deficiency diseases and auto immune disorders must be searched for as causes of FUO.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants and children
Key inclusion criteria (1 listed)
- All FUO cases admitted to AUCH during one year of the study.
Key exclusion criteria (1 listed)
- cases of HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tuberculin testtuberclin test used to diagnose tuberculosis as cause of fever of unknown origin | Diagnostic test | – |
Primary outcome
Causes of Fever of unknown origin (FUO) in infants and children attending Assiut University Children Hospital (AUCH)
Time frame: Baseline
investigations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Background: PubMed 27143687Chien 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.
- Background: PubMed 29742054Attard 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.
- Background: PubMed 22166749Antoon 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.
- Background: PubMed 24899875Hassan 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.
- Individual participant dataSharing planned: Undecided
Related trials for Fever of Unknown Origin
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
Recruiting
Comparison of FDG-PET/CT and CECT-CAP as Upfront Imaging Modality for the Diagnosis of Pyrexia of Unknown Origin
Pyrexia
Active, not recruitingPhase 3
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
Systemic Juvenile Idiopathic Arthritis
Active, not recruitingObservational study
PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Inflammatory Rheumatism, Polymyalgia Rheumatica
RecruitingObservational study
A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients
Familial Mediterranean Fever, Still Disease
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever of Unknown Origin, run by Assiut University.
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 1 inclusion and 1 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 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Safiea El-Deeb, prof (0220882060380, Safia.eldeeb@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Causes of Fever of unknown origin (FUO) in infants and children attending Assiut University Children Hospital (AUCH) (time frame: Baseline). 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 NCT04073108, which also lists 4 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 29 Aug 2019.