Gram-Negative Bacterial InfectionsNCT02666274
Feasibility Studies to Inform Novel Proposals to Avert Community-Based Antimicrobial Resistance Spread
An observational study of Gram-Negative Bacterial Infections, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-Negative Bacterial Infections
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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'):
- Inclusion criteria for index participants are being at least 16 years of age, able to consent for themselves and to communicate in English at the time of being invited to participate in the study. Inclusion criteria for index participants in the RK group include gut colonisation by Klebsiella spp. with resistance to carbapenems or third generation cephalosporins, as demonstrated by the analysis of a stool sample provided at baseline. Inclusion criteria for index participants in the control group, are lack of colonisation by bacteria resistant to third generation cephalosporins or carbapenems, as demonstrated by the analysis of a stool sample provided at baseline and at 6 months after discharge from hospital.
- Inclusion criteria for network participants are persons of any age who are sharing the household with an index participant in the RK group and who meet the definition of usual household resident.
Who cannot join
- Study A ('Mapping'): Exclusion criteria include data from penitentiary patients.
- Study B ('Tracking'):
- Exclusion criteria for index participants are those not meeting the inclusion criteria, penitentiary patients, those with no fixed adobe or not residing in a household space as defined in this study, and those living alone.
- Exclusion criteria for network participants are those not meeting the inclusion criteria, those meeting exclusion criteria as defined for index participants, those who are adults unable to consent for themselves, and those who are not able to communicate in English.
- Exclusion criteria for households are those not meeting the inclusion criteria, those where the index participant resides alone (i.e. no other usual residents in the household), those were at least one resident is not eligible for inclusion (including where a resident does not meet the definition of usual resident), those where at least one usual resident does not want to take part in the study, and those which are more than one hour commute from the study site
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, London, SE1 7EH
Olga Tosas, PhD, +442071888163, olga.tosas@gstt.nhs.uk
About this study
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.
Read the detailed description
- 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.
- Conditions
- Gram-Negative Bacterial Infections
- Keywords
- carbapenem resistance, bacterial carriage, multi-drug resistant gram negative bacteria
- Medical subject headings
- Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RK Group | participants colonised with Klebsiella spp. resistant to either 3GC or carbapenems (RK cohort of index carriers of Resistant Klebsiella) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Negative Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Edgeworth, MBBS, Principal investigator, Guy's and St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666274
- Sponsor's protocol ID
- RJ115/N354
- Status last verified
- Nov 2016
- First submitted
- 18 Jan 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Studies to Inform Novel Proposals to Avert Community-Based Antimicrobial Resistance Spread
- ClinicalTrials.gov ID
- NCT02666274
- Acronym / sponsor ID
- RJ115/N354
- Conditions
- Gram-Negative Bacterial Infections
- Keywords
- carbapenem resistance, bacterial carriage, multi-drug resistant gram negative bacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RK Group | – | –participants colonised with Klebsiella spp. resistant to either 3GC or carbapenems (RK cohort of index carriers of Resistant Klebsiella) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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'):
Key exclusion criteria (5 listed)
- Study A ('Mapping'): Exclusion criteria include data from penitentiary patients.
- Exclusion criteria for index participants are those not meeting the inclusion criteria, penitentiary patients, those with no fixed adobe or not residing in a household space as defined in this study, and those living alone.
- Exclusion criteria for network participants are those not meeting the inclusion criteria, those meeting exclusion criteria as defined for index participants, those who are adults unable to consent for themselves, and those who are not able to communicate in English.
- Exclusion criteria for households are those not meeting the inclusion criteria, those where the index participant resides alone (i.e. no other usual residents in the household), those were at least one resident is not eligible for inclusion (including where a resident does not meet the definition of usual resident), those where at least one usual resident does not want to take part in the study, and those which are more than one hour commute from the study site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Edgeworth, MBBS principal investigator
Guy's and St Thomas NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gram-Negative Bacterial Infections, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Tosas, phD DVM (+442071888163, olga.tosas@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transmission of resistant gram negative bacteria from index participants and network participants (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.