EnterobacteriaceaeReSWABNCT07847606
Diagnostic Performance and Acceptability of Rectal Swab for Screening of ESBL Enterobacterales
A study testing Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurse in people with Enterobacteriaceae and Swabs, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
The goal of this interventional study without drugs and medical devices is to assess the accuracy of the self-administered rectal swab compared to the "gold standard" performed by healthcare professionals used for the diagnosis of βlactamase extended spectrum (ESBL) Enterobacterales Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterobacteriaceae, Swabs, Beta Lactam Resistant Bacterial Infection
- What is being tested?
- Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 18 years of age and above
- Suitability of swab collection within 48 hours from hospitalization
- Signed informed consent and authorization for the participation in the study and for the use of personal data
- Age over 18 years
- Patient's consent to have the rectal swab performed by their caregiver
- Caregiver signed informed consent
- Availability to perform the rectal swab on the patient
Who cannot join
- Hospitalization in the previous 90 days for at least 2 days (excluding Day Hospital)
- Hospitalization in the previous 90 days of ≥2 days in nursing homes or community hospitals
- Patients in emergency situations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance and Acceptability of a Self-collected Rectal Swab for Screening of β Lactamase Extended Spectrum Enterobacterales
The goal of this interventional study without drugs and medical devices is to assess the accuracy of the self-administered rectal swab compared to the "gold standard" performed by healthcare professionals used for the diagnosis of βlactamase extended spectrum (ESBL) Enterobacterales
Read the detailed description
This is an experimental study without drugs and medical devices to assess the accuracy of the self-administered rectal swab compared to the "gold standard" performed by healthcare professionals used for the diagnosis of βlactamase extended spectrum (ESBL) Enterobacterales in patients admitted to the hospital without a scheduled intestinal surgery.
Rectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver will be compared th screening rectal swab performed by the nurse. Swabs will be stored in the ward refrigerator until delivery to the Microbiology laboratory within 24 hours from collection, where they will be analyzed.
- Being tested
- Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurse
- Keywords
- Enterobacteriaceae, self-made rectal swab, β lactamase extended spectrum Enterobacterales
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurseDiagnostic test
Rectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver) and then by the nurse. Both samples will be analyzed within 24 hours from collection. The molecular test will be performed on the ELITe InGenius platform, an integrated system that automatically performs nucleic acid extraction, real-time polymerase chain reaction (PCR) and interpretation of results in less than 3 h. The amplification analysis will be performed using the ESBL ELITe MGB kit. This is a qualitative multiplex real-time PCR assays for the detection of the most prevalent ESBL-encoding genes in Enterobacterales.
This assay utilizes 200 µl of sample; after DNA extraction, the InGenius platform sets up the PCR using 20 µl of DNA, 10 µl of Internal Control and 20 µl of PCR Mix.
At the end of the sample collection, the patient will be given a questionnaire on the acceptability of the self-administered rectal swab which must be completed by the end of hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Rectal swab performed by the patient (or the caregiver) and then by the nurse | Experimental | Rectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver) and then by the nurse. Both samples will be analyzed within 24 hours from collection Receives: Diagnostic Test: Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the self-administered rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL Enterobacterales
Measured: 24 hours after swabs collection
Secondary outcomes (3)
Prevalence of ESBL-E in the community population prior to hospital admission
Measured: 24 hours after swabs collection
Accuracy of the caregiver rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL- Enterobacterales
Measured: 24 hours after swabs collection
Study questionnaire results on acceptability of patients self-administering rectal swabs
Measured: through hospital discharge, an avarage of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start12 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnterobacteriaceaeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847606
- Sponsor's protocol ID
- 2025-22
- Acronym
- ReSWAB
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Acceptability of a Self-collected Rectal Swab for Screening of β Lactamase Extended Spectrum Enterobacterales
- ClinicalTrials.gov ID
- NCT07847606
- Acronym / sponsor ID
- ReSWAB / 2025-22
- Keywords
- Enterobacteriaceae, self-made rectal swab, β lactamase extended spectrum Enterobacterales
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- 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.
The goal of this interventional study without drugs and medical devices is to assess the accuracy of the self-administered rectal swab compared to the "gold standard" performed by healthcare professionals used for the diagnosis of βlactamase extended spectrum (ESBL) Enterobacterales
Detailed description
This is an experimental study without drugs and medical devices to assess the accuracy of the self-administered rectal swab compared to the "gold standard" performed by healthcare professionals used for the diagnosis of βlactamase extended spectrum (ESBL) Enterobacterales in patients admitted to the hospital without a scheduled intestinal surgery.
Rectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver will be compared th screening rectal swab performed by the nurse. Swabs will be stored in the ward refrigerator until delivery to the Microbiology laboratory within 24 hours from collection, where they will be analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal swab performed by the patient (or the caregiver) and then by the nurse | Experimental | Diagnostic Test: Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurseRectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver) and then by the nurse. Both samples will be analyzed within 24 hours from collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age and above
- Suitability of swab collection within 48 hours from hospitalization
- Signed informed consent and authorization for the participation in the study and for the use of personal data
- Age over 18 years
- Patient's consent to have the rectal swab performed by their caregiver
Key exclusion criteria (3 listed)
- Hospitalization in the previous 90 days for at least 2 days (excluding Day Hospital)
- Hospitalization in the previous 90 days of ≥2 days in nursing homes or community hospitals
- Patients in emergency situations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurseRectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver) and then by the nurse. Both samples will be analyzed within 24 hours from collection. The molecular test will be performed on the ELITe InGenius platform, an integrated system that automatically performs nucleic acid extraction, real-time polymerase chain reaction (PCR) and interpretation of results in less than 3 h. The amplification analysis will be performed using the ESBL ELITe MGB kit. This is a qualitative multiplex real-time PCR assays for the detection of the most prevalent ESBL-encoding genes in Enterobacterales. This assay utilizes 200 µl of sample; after DNA extraction, the InGenius platform sets up the PCR using 20 µl of DNA, 10 µl of Internal Control and 20 µl of PCR Mix. At the end of the sample collection, the patient will be given a questionnaire on the acceptability of the self-administered rectal swab which must be completed by the end of hospitalization | Diagnostic test | Rectal swab performed by the patient (or the caregiver) and then by the nurse |
Primary outcome
Accuracy of the self-administered rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL Enterobacterales
Time frame: 24 hours after swabs collection
3 secondary outcomes
Prevalence of ESBL-E in the community population prior to hospital admission
Time frame: 24 hours after swabs collection
Accuracy of the caregiver rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL- Enterobacterales
Time frame: 24 hours after swabs collection
Study questionnaire results on acceptability of patients self-administering rectal swabs
Time frame: through hospital discharge, an avarage of 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurse in people with Enterobacteriaceae and Swabs, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the self-administered rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL Enterobacterales (time frame: 24 hours after swabs collection). 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 29 Sep 2026.