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

NCT04884958 | Unknown

• 1 other identifier: 164460
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Staphylococcus Aureus

Keywords

Carriage; Household transmission; MRSA

Outcome Measures

Primary Outcomes (1)

• Determine the baseline prevalence of Staphylococcus aureus carriage or infection in household contacts of hospital inpatients diagnosed with clinical infection due to Staphylococcus aureus.

  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.

Secondary Outcomes (3)

• Measure the frequency of Staphylococcus aureus transmission events within households over a three month period.

  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.

  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

  Data analysis will occur throughout and beyond the study recruitment period, expected to take a minimum of 6 months.

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sheffield: lead
• Rajarata University, Sri Lanka: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Superficial swabs taken from the anterior nares and any clinical sites of infection and then processed for bacterial culture.

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Thomas Darton

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Darton

CONTACT

+44 114 215 9530; t.darton@sheffield.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: May 13, 2021
• Study Start: May 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-03