Feasibility Studies to Inform Novel Proposals to Avert Community-Based Antimicrobial Resistance Spread
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|ClinicalTrials.gov Identifier: NCT02666274|
Recruitment Status : Unknown
Verified November 2016 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : January 28, 2016
Last Update Posted : November 28, 2016
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.
|Condition or disease|
|Gram-Negative Bacterial Infections|
- Study A. Mapping of resistant gram negative bacteria (RGNB) in the community: Based on RGNB clinical isolates as a proxy for gut colonising RGNB and residential Lower Layer Super Output Area (LSOA) data retrieved from laboratory information systems of a hospital cohort, to describe the geographical distribution of RGNB in South East London in relation to demographic, cultural and socioeconomic indicators and to investigate whether geographical clustering of resistance, compatible with the occurrence of community based transmission hotspots, occurs in our local community.
- Study B. Tracking gut colonisation with carbapenem resistant Klebsiella spp. or Klebsiella spp. resistant to third generation cephalosporins (3GC), herein referred to as 'Resistant Klebsiella' (RK):
To investigate the duration of gut colonisation with Klebsiella spp. in a small cohort of discharged hospital patients with resistance to the carbapenems (eg. meropenem), defined by presence of either blaKPC, blaNDM, blaIMP , blaVIM or blaOXA48 genes, or Klebsiella spp. with resistance to the 3GC (eg. ceftazidime), defined by presence of blaCTX_M or AmpC βlactamase genes. To determine the occurrence of participant to participant RK transmission events within a household, in relation to gut bacterial load and the gut microbiota profile. To characterise over time, the gut microbiota profile of participants colonised with RK as compared to participants who only carry antibiotic susceptible enterobacteria in the gut. It is beyond the scope of our feasibility study to enrol a sample of persons that is representative of the wider population, or to account for sample size and power calculations that would allow for characterisation of statistically meaningful associations.
|Study Type :||Observational|
|Estimated Enrollment :||45 participants|
|Observational Model:||Case Control|
|Official Title:||Feasibility Studies to Inform Novel Proposals to Avert Community-Based Antimicrobial Resistance Spread|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||June 2017|
participants colonised with Klebsiella spp. resistant to either 3GC or carbapenems (RK cohort of index carriers of Resistant Klebsiella)
- Transmission of resistant gram negative bacteria from index participants and network participants [ Time Frame: 6 months ]To measure household transmission between index participants and household members of resistant bacteria through collection of stool samples.
- Length of Gut Carriage of resistant gram negative bacteria in index participants [ Time Frame: 6 months ]Measure how long resistant gram negative bacteria persist in the stool by measuring carriage of bacteria in longitudinal stool samples
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666274
|Contact: Olga Tosas, phD DVMfirstname.lastname@example.org|
|Contact: Jonathan Edgeworth, MBBSemail@example.com|
|Guy's and St Thomas' NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Olga Tosas, PhD +442071888163 firstname.lastname@example.org|
|Principal Investigator:||Jonathan Edgeworth, MBBS||Guy's and St Thomas NHS Foundation Trust|