A Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka
12 mai 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
300
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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.
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Household contacts
This cohort are resident in the same household as the index patient (maximum of four).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus.
Délai: First household visit and swabbing of household contacts will be as soon as possible after recruitment of the index case.
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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.
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First household visit and swabbing of household contacts will be as soon as possible after recruitment of the index case.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Measure the frequency of Staphylococcus aureus transmission events within households over a three month period.
Délai: 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).
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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.
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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).
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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.
Délai: 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).
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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.
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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).
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Describe virulence characteristics of strains causing a) (invasive) infection and b) higher number of household transmission events
Délai: Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.
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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.
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Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Thomas Darton, University of Sheffield
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 mai 2021
Achèvement primaire (Anticipé)
1 juillet 2021
Achèvement de l'étude (Anticipé)
1 septembre 2021
Dates d'inscription aux études
Première soumission
3 mars 2021
Première soumission répondant aux critères de contrôle qualité
12 mai 2021
Première publication (Réel)
13 mai 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 mai 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 mai 2021
Dernière vérification
1 mars 2021
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 164460
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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