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Transcriptomic Responses for the Identification of Pathogens (TRiP)

15. juni 2022 opdateret af: University of Sheffield

A Multisite Evaluation of Functional Genomic Signatures for the Improved Diagnosis of Acute Undifferentiated Febrile Infections

Acute undifferentiated febrile infection (AUFI) is a common presenting syndrome in low-resource settings and better diagnostics are urgently needed to improve patient management and guide disease prevention interventions. Assessment of the host gene expression response to infection in endemic populations has demonstrated significant promise as a new approach to identifying patients with enteric fever and for potential in differentiating between other causes of AUFI. Signatures identified through new data analytic techniques could be developed into a point-of-care test for use in endemic settings.

In this multisite diagnostic evaluation study we will collect prospective clinical, laboratory and diagnostic data from two endemic settings to evaluate host gene expression signatures for detecting enteric fever and for determining the cause of AUFI in LMIC settings.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

2000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Indien
      • Vellore, Indien
        • Rekruttering
        • Christian Medical Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 45 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

We will recruit adults aged 15 to 45 years presenting to hospital with fever at 2 sites in Asia where enteric fever is endemic. All included febrile participants will have a documented tympanic/rectal temperature of ≥ 38°C or an axillary/oral temperature of ≥ 37.8°C on presentation and will report a history of fever lasting 3 to 14 days. In parallel, healthy community control participants will be recruited from each site catchment area during the course of the study with enrolment designed to result in an even representation of age groups and seasonal variation. Identified signatures of infection will be explored in a cohort of febrile children aged 2 to 14 years at each site. 600 febrile adults, 200 febrile children and 200 afebrile adult controls will be recruited at each site.

Beskrivelse

FEBRILE ADULTS- INCLUSION CRITERIA

  • Age greater than or equal to 15 years and less than or equal to 45 years
  • Participant is willing and they and/or an appropriate guardian/relative/representative is able to give informed consent for participation in the study and a follow-up (telephone) discussion at 14 days

  • Febrile illness without localising features (see 'exclusion criteria' and 'screening' sections) where fever is defined as:

    • documented tympanic/rectal temperature of ≥ 38°C or an axillary/oral temperature of ≥ 37.8°C and
    • Reported duration of fever 3-14 days
  • They may have had recent exposure to antimicrobials.

FEBRILE ADULTS- EXCLUSION CRITERIA

  • The participant may not enter the study if ANY of the following apply:
  • Unable to provide informed consent and no next of kin is willing and able to provide informed consent.

  • Any history or clinical suspicion of:

    • Rheumatological or connective tissue disorder (e.g. Rheumatoid arthritis)
    • Autoimmune condition (e.g. Autoimmune Hepatitis)
    • Malignancy
    • Active treatment with immunomodulating medications, or for tuberculosis (pulmonary or extrapulmonary) or any other chronic infection.
  • Pregnancy (breast feeding mothers will NOT be excluded)
  • Hospitalisation within 4 weeks prior to current admission
  • Vaccination within 4 weeks prior to current admission
  • They live outside of the normal/local catchment area for each hospital site
  • Localising signs or symptoms of infection sufficient to diagnose the likely cause of acute febrile illness and thus prevent it from being 'undifferentiated' (see Section 8.4 'Screening and Eligibility').

CONTROLS- INCLUSION CRITERIA

  • Participant is willing and they are (and in 15-18 year olds, a guardian is) able to give informed consent for participation in the study
  • Age greater than or equal to 15 years and less than or equal to 45 years
  • They live outside of the normal/local catchment area for each hospital site
  • Afebrile (as defined by no reported fever and temperature ≤ 38°C or an axillary/oral temperature of ≤ 37.8°C).

CONTROLS- EXCLUSION CRITERIA

  • The participant may not enter the study if ANY of the following apply:
  • Unable to provide informed consent and no next of kin (or parent/guardian in the case of a minor) is willing and able to provide informed consent.

  • Current treatment for or prior history, or clinical suspicion of:

    • Rheumatological or connective tissue disorder
    • Autoimmune condition
    • Malignancy
    • Active treatment for tuberculosis (pulmonary or extrapulmonary) or clinical suspicion of active tuberculosis. Previous completed treatment is not a reason for exclusion.
    • Active treatment with immunomodulating medications or any other chronic infection.
  • Pregnant (breast feeding mothers will NOT be excluded)
  • Hospitalisation within 4 weeks of recruitment
  • Vaccination within 4 weeks prior to recruitment
  • Antimicrobial use within 4 weeks of recruitment
  • They live outside of the normal/local catchment area for each hospital site
  • Participant reports feeling more unwell than usual on the day of enrolment.

EXPLORATORY AIMS- PAEDIATRIC CRITERIA; INCLUSION CRITERIA

  • Age greater than or equal to 2 years and less than 15 years
  • As above for adult participants.

EXPLORATORY AIMS- PAEDIATRIC CRITERIA; EXCLUSION CRITERIA

  • Parent/guardian is unwilling, and/or patient aged 8 to 14 years is unwilling to assent to provide informed consent.
  • As above for adult participants.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Febrile Adults
1200 adult participants (15 to 45 years old) with a febrile illness without localising features and reported duration of 3-14 days.
Diagnostisk test: 5-gene transcription signature
This is a prospective multisite diagnostic evaluation study to assess a novel approach to the diagnosis of enteric fever. The index test of host gene transcription responses by a 5 gene-signature will be compared to the reference test of blood culture confirmation for a diagnosis of enteric fever in patients with AUFI.
Controls
400 afebrile, healthy adult participants (15 to 45 years old).
Diagnostisk test: 5-gene transcription signature
This is a prospective multisite diagnostic evaluation study to assess a novel approach to the diagnosis of enteric fever. The index test of host gene transcription responses by a 5 gene-signature will be compared to the reference test of blood culture confirmation for a diagnosis of enteric fever in patients with AUFI.
Febrile Children
400 child participants (2 to 14 years old) with a febrile illness without localising features and reported duration of 3-14 days. This is an exploratory arm of the study.
Diagnostisk test: 5-gene transcription signature
This is a prospective multisite diagnostic evaluation study to assess a novel approach to the diagnosis of enteric fever. The index test of host gene transcription responses by a 5 gene-signature will be compared to the reference test of blood culture confirmation for a diagnosis of enteric fever in patients with AUFI.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity and specificity (AUROC) of a diagnostic score derived from transcriptional responses by a 5-gene transcription signature (STAT1, SLAMF8, PSME2, WARS, ALDH1A1) in classifying patients with blood culture-confirmed enteric fever.
Tidsramme: 2.5 years
Evaluate the performance of a host gene transcription signature for detecting enteric fever in adults presenting with acute undifferentiated fever (AUFI)
2.5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with diagnosis confirmed by laboratory testing.
Tidsramme: 2.5 years
Determine the frequency of other common causes of AUFI at each site.
2.5 years
Number of participants presenting with mild, moderate or severe illness by clinical diagnosis according to validated prognostic scores such as sepsis scoring systems.
Tidsramme: 2.5 years
Assess the relationship between markers of clinical illness severity, likely infection cause and level of molecular perturbation.
2.5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Sheffield

Samarbejdspartnere

Christian Medical College, Vellore, India

Efterforskere

  • Studieleder: Thomas Darton, University of Sheffield

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. maj 2022

Primær færdiggørelse (Forventet)

1. januar 2024

Studieafslutning (Forventet)

1. juni 2024

Datoer for studieregistrering

Først indsendt

20. januar 2021

Først indsendt, der opfyldte QC-kriterier

5. maj 2021

Først opslået (Faktiske)

7. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 157365

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