A Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka
12. května 2021 aktualizováno: 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.
Přehled studie
Postavení
Neznámý
Podmínky
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Očekávaný)
300
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
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).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus.
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Measure the frequency of Staphylococcus aureus transmission events within households over a three month period.
Časové okno: 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.
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Thomas Darton, University of Sheffield
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Očekávaný)
1. května 2021
Primární dokončení (Očekávaný)
1. července 2021
Dokončení studie (Očekávaný)
1. září 2021
Termíny zápisu do studia
První předloženo
3. března 2021
První předloženo, které splnilo kritéria kontroly kvality
12. května 2021
První zveřejněno (Aktuální)
13. května 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. května 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. května 2021
Naposledy ověřeno
1. března 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 164460
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .