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A Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka

12 maggio 2021 aggiornato da: University of Sheffield

A Prospective Cohort Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka

This study will determine the frequency of Staphylococcus aureus carriage in household contacts of individuals with clinical infection due to this pathogen. It will also assess the frequency of transmission events over the following three months. Finally it will aim to identify predisposing characteristics both on a demographic/social level as well virulence characteristics of the identified strains.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Descrizione dettagliata

This is a prospective cohort study based at Anuradhapura Teaching Hospital (Sri Lanka). Potential index study participants will have clinical infection caused by Staphylococcus aureus and will be identified from hospital microbiology laboratory records within 48 hours of admission. With consent, the investigators will approach up to 4 household members for participation in the carriage study. With their consent, household members will have swabs collected on 2 occasions 3 months apart. All hospitalised patients will receive standard-of-care treatment in accordance with local practice and national guidance. Clinical, demographic and social/lifestyle data will be collected from index patients and households by scheduled interview performed by local investigators. Bacterial isolates from the initial index patient infection, and those identified through household member screening will be assessed for antimicrobial susceptibility, virulence factor repertoire and analysed by whole genome sequencing. While infection with the cc5 MRSA clone has been described in several hospital and hospital-associated settings in South Asia a major unresolved issue is whether transmission and circulation of this clone is occurring in community settings. In this study the investigators will investigate and characterise the household circulation of Staphylococcus aureus strains, exploring differences in bacterial virulence characteristics and host susceptibility factors associated with increased risk of carriage. Understanding these factors and estimating the burden of disease which may be occurring in the community setting will allow more accurate assessment of the risk posed by cc5 PVL-MRSA to similar Low and Middle Income Countries (LMIC) settings and signal potential routes to mitigation through treatment optimisation and disease prevention including infection control or vaccination.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The index patients will have clinical infection due to Staphylococcus aureus identified during admission to Anuradhapura General Hospital.

The household contacts will be resident in the same household as the index patient so will be part of the local community served by Anuradhapura General Hospital.

Descrizione

Inclusion Criteria (index patient):

  • Confirmed clinical infection caused by Staphylococcus aureus infection, including skin and soft tissue infection (SSTI) or infection of a normally sterile site.
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female greater or equal to 18 years old.
  • Household is within one day's travel of the Hospital.

Inclusion Criteria (household contact):

  • Resident in the same household as index participant.
  • Participant is willing and able to give informed consent for participation in the study if greater or equal to 18 years old or the parent/legal guardian if participant is less than 18 years old.
  • Likely continued household residence for at least 3 months from initial sample collection.
  • Able to comply with study requirements.

Exclusion Criteria (index patient):

- Deemed unsuitable by the responsible clinical team/clinician (e.g. terminal illness).

Exclusion Criteria (household contact):

  • Not a resident of the household at the time of the index patient hospital admission.
  • Deemed unsuitable by the responsible clinical team/clinician (e.g. terminal illness)
  • At least 4 household contacts already enrolled to this study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Index patient
Adults with confirmed clinical infection caused by Staphylococcus aureus, including skin and soft tissue infection or infection of a normally sterile site. These cases will be identified following admission to Anuradhapura General Hospital.
Household contacts
This cohort are resident in the same household as the index patient (maximum of four).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus.
Lasso di tempo: First household visit and swabbing of household contacts will be as soon as possible after recruitment of the index case.
Index cases will be identified by screening laboratory reports for samples obtained within 72 hours of hospital admission and where Staphylococcus aureus has been isolated from a skin or soft tissue infection or a normally sterile site and there is a clinical diagnosis of infection at that site. Up to 4 household contacts of this index case will be approached to participate in the study and will have bacterial swabs of the anterior nares and any incidental sites of infection at an initial assessment (as soon after identification and recruitment as possible). The swabs will be inoculated on to blood agar and MacConkey agar. Staphylococcus aureus will be identified by colonial morphology, Gram stain, catalase test and coagulase test. Methicillin resistant Staphylococcus aureus will be detected by disc diffusion method using a cefoxitin disc as per the CLSI protocol.
First household visit and swabbing of household contacts will be as soon as possible after recruitment of the index case.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Measure the frequency of Staphylococcus aureus transmission events within households over a three month period.
Lasso di tempo: First visit and swabbing of the index and household contacts will be as soon as possible after recruitment of the index case. Both the index and household contacts will have a second visit 3 months later (window 2-4 months).
Proportion of household individuals carrying same/similar strains, as determined by similarity in antimicrobial susceptibility profile and genotypic homology. This will be assessed over a three month time period to detect possible household transmission in contacts who are initially not detected as carriers.
First visit and swabbing of the index and household contacts will be as soon as possible after recruitment of the index case. Both the index and household contacts will have a second visit 3 months later (window 2-4 months).
Characterise predisposing clinical, demographic or social characteristic differences of individuals/households with evidence of household transmission over a three month period by interview and completion of a proforma.
Lasso di tempo: The baseline interviews will occur as soon as possible after the index patient is recruited and the second interview will occur three months later (window 2-4 months).
After consent is obtained, study investigators will visit the dwellings to assess up to 4 household contacts. A baseline interview using a proforma will be conducted to investigate each individual and their shared dwellings. This will include identification of: dwelling location, type of dwelling, number of other inhabitants, pet/animal ownership, occupations, duration of residence, recent illness/hospitalisations, recent courses of antimicrobial treatment. This will be repeated at the follow up visit to ensure there have not been any change in circumstances.
The baseline interviews will occur as soon as possible after the index patient is recruited and the second interview will occur three months later (window 2-4 months).
Describe virulence characteristics of strains causing a) (invasive) infection and b) higher number of household transmission events
Lasso di tempo: Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.
Analysis of whole genome sequencing and antimicrobial virulence data from isolates that are more associated with infection (in the index and household contacts) and where a high frequency of household transmission has been observed.
Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Sheffield

Collaboratori

Rajarata University, Sri Lanka

Investigatori

  • Investigatore principale: Thomas Darton, University of Sheffield

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 maggio 2021

Completamento primario (Anticipato)

1 luglio 2021

Completamento dello studio (Anticipato)

1 settembre 2021

Date di iscrizione allo studio

Primo inviato

3 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2021

Primo Inserito (Effettivo)

13 maggio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 maggio 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 164460

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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