Feasibility Studies to Inform Novel Proposals to Avert Community-Based Antimicrobial Resistance Spread

NCT02666274 | Unknown

• 1 other identifier: RJ115/N354
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

There are many bacteria that naturally live in our gut and are essential for good health. These bacteria have a variety of helpful functions, such as aiding digestion, synthesizing vitamins, repressing the growth of harmful bacteria and defending against some diseases. The desirable bacteria that live in the gut are collectively known as 'gut flora', or more appropriately, as 'gut microbiota'. The less desirable resistant bacteria, however, can also be carried in a person's gut for prolonged periods of time and be found in the stools without causing illness. Persons that carry the resistant bacteria in the gut are known as "carriers" and they require no treatment. Knowing that a person carries resistant bacteria is helpful, because it will inform the choice of antibiotic if the person were to become unwell or had an intervention such as surgery in the future. There is some evidence that resistant bacteria found in the stools can sometimes be passed from one person to another and eventually make someone ill if they infect (invade) their body. The investigators do not know how often this may happen, or how much carrying resistant bacteria in the stools may facilitate the spread of resistant bacteria in the population. It is important to address these questions and study ways to stop the resistant bacteria from spreading to safeguard the efficacy of antibiotics.

Conditions

Gram-Negative Bacterial Infections

Keywords

carbapenem resistance; bacterial carriage; multi-drug resistant gram negative bacteria

Outcome Measures

Primary Outcomes (2)

• Transmission of resistant gram negative bacteria from index participants and network participants

  To measure household transmission between index participants and household members of resistant bacteria through collection of stool samples.

  6 months

• Length of Gut Carriage of resistant gram negative bacteria in index participants

  Measure how long resistant gram negative bacteria persist in the stool by measuring carriage of bacteria in longitudinal stool samples

  6 months

Study Arms (1)

RK Group

participants colonised with Klebsiella spp. resistant to either 3GC or carbapenems (RK cohort of index carriers of Resistant Klebsiella)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any adult hospitalized patient at Guy's and St Thomas' Foundation Trust who carries resistant gram negative bacteria on a screening or clinical sample

You may qualify if:

• Study A ('Mapping'): Retrospective data collection from the hospital laboratory information system on patients diagnosed with infection and/or colonisation by relevant gram negative bacteria and antibiotic resistance profile.
• Study B ('Tracking'):

You may not qualify if:

• Study B ('Tracking'):

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, London, SE1 7EH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool samples

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jonathan Edgeworth, MBBS

  Guy's and St Thomas NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Tosas, phD DVM

CONTACT

+442071888163; olga.tosas@gstt.nhs.uk

Jonathan Edgeworth, MBBS

CONTACT

+4420171887188; jonathan.edgeworth@gstt.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 28, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 28, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)