ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children (ERNIE4)
Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study
Studieoversikt
Detaljert beskrivelse
The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely children presenting to ambulatory care.
The cross-sectional cohort study will compare an innovative urine test with conventional dipstick testing to establish their relative accuracy to diagnose urinary tract infections, and construct an algorithm consisting of clinical features, urine test results and CRP point-of-care testing to identify serious infections. The longitudinal follow-up study will describe illness trajectories of children with an intermediate CRP test result (5-80 mg/L) at first contact.
The study will run in general practices and community paediatrics in Flanders. Recruitment to the study is expected to last 18 months, with each patient entering the study only once. Children and their parents/guardians will be approached for possible participation in the study by practice staff. There is only one study visit.
Those who agree to participation via written informed consent will have demographics and clinical features recorded. All children will be asked to provide a urine sample on study entry. Subsequently, CRP point-of-care testing will be conducted in all children testing positive on a clinical prediction rule, and in a random sample of children testing negative on that rule. Follow-up information for all children will be collected using general practice notes, hospital records and direct patient/parent contact.
Treatment and other management decisions will be left to the treating physicians' discretion.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Leuven, Belgia, 3000
- KU Leuven
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Aged 3 months to 18 years
- Presenting to a general practice or community paediatrics
- Acute illness of a maximum of 10 days
- Parent or guardian is willing and able to give informed consent for participation
Exclusion Criteria:
- Clinically unstable warranting immediate care
- Urinary catheter in situ
- Immunosuppressant medication taken in the previous 30 days
- Trauma is the main presenting problem
- Antibiotics taken in the previous 7 days
- Children who present to community paediatrics as a result of direct GP referral
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: CRP in all
All children will undergo a CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott). There will be only 1 test at study entry |
CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)
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Eksperimentell: CRP in high risk children only
Children who are positive on a clinical prediction rule for serious infections in children will undergo CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott). There will be only 1 test at study entry |
CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Urinary tract infection
Tidsramme: 3 days
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The number of children with a urinary tract infection based on urine culture
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3 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serious infections
Tidsramme: 30 days
|
The number of children admitted to hospital for a serious infection which can be pneumonia, sepsis, meningitis, pyelonephritis, osteomyelitis or appendicitis
|
30 days
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Final diagnosis
Tidsramme: 30 days
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For children not admitted to hospital, the final diagnosis based on all available clinical information from ambulatory care assessment over 30 days after the index date.
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30 days
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Duration of symptoms
Tidsramme: 30 days
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For all children, the duration of symptoms after the index date based on patient diaries
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30 days
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Healthcare resource use
Tidsramme: 30 days
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For all children, re-consultation rates in ambulatory care after the index date
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30 days
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Healthcare resource use
Tidsramme: 30 days
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For all children, ED attendance after the index date
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30 days
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Healthcare resource use
Tidsramme: 30 days
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For all children, hospital admission after the index date
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30 days
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ann Van den Bruel, MD PhD, ACHG, KU Leuven
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- S61991
Plan for individuelle deltakerdata (IPD)
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