Drug Resistance, MicrobialINVICTUSNCT07675018
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
A study testing Detection of integrons and Gold standard in people with Drug Resistance, Microbial and Biomarkers, run by University Hospital, Limoges at 7 sites in France.
Trial summary
Urinary tract infections (UTI), mainly driven by Gram-negative bacteria (GNB) are a frequent cause of hospitalization and the second cause of antibiotic prescription after lower respiratory tract infections. Integrons play a major role in the dissemination of antibiotic resistance among GNB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistance, Microbial, Biomarkers, Urinary Tract Infections (UTI's)
- What is being tested?
- Detection of integrons and Gold standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 7 sitesFrance
- Study dates
- 20 Sep 2026to 26 Sep 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
- Age ≥ 18 years old; Hospitalized or admitted to the Emergency department;
- Diagnosis of non-severe (qSOFA < 2) urinary tract infection coupled with fever ≥ 38°C or < 36°C
- Presence of bacteria in the fresh urine sample and/or GNB on the Gram stain
- Empirical parenteral antibiotic therapy required; Hospitalization required;
- Former documentation of a 3GC-resistant GNB on a microbiological sample in the previous six months
- Informed consent of the patient or their representative
Who cannot join
- Pregnant and/or breastfeeding
- Neutropenia (absolute neutrophil count < 500 / mm3)
- Severe UTI with sepsis (qSOFA ≥ 2) or septic shock
- Urinary derivation required (ureteral catheter/per-cutaneous nephrostomy) except for simple urinary catheterization
- Known allergy to β-lactams
- Patients with a former documentation with carbapenemase-producing Enterobacterales in the last 6 months
- Ongoing antibiotic treatment with 3GC, piperacillin-tazobactam or carbapenem
- Not affiliated to Social Security
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CHRU Tours, Hôpital Trousseau
Chambray-lès-Tours, 37170
Geoffroy ROUSSEAU, MD, 0247474747 ext. +33, geoffroy.rousseau@chu-tours.fr
Geoffroy ROUSSEAU, MD
- Not yet recruiting
Grenoble university hospital
La Tronche, 38700
Damien VIGLINO, MD, 476765934 ext. +33, dviglino@chu-grenoble.fr
Damien VIGLINO, MD
- Recruiting
Limoges university hospital
Limoges, 87042
Thomas LAFON, MD, 555056254 ext. +33, thomas.lafon@chu-limoges.fr
Thomas LAFON, MD
- Not yet recruiting
Hopital lariboisière
Paris, 75010
Anthony CHAUVIN, MD, anthony.chauvin@aphp.fr
Anthony CHAUVIN, MD
- Not yet recruiting
Hôpital Saint Louis - APHP
Paris, 75010
Olivier Peyrony, MD, 0667986515 ext. +33, olivier.peyrony@aphp.fr
Olivier PEYRONY, MD
- Not yet recruiting
Groupe Hospitalier Universitaire Bichat-Claude Bernard - APHP
Paris, 75018
Christophe CHOQUET, MD, 0140256012 ext. +33, christophe.choquet@aphp.fr
Christophe CHOQUET, MD
- Not yet recruiting
CHU de Reims
Reims, 51100
Stéphane GENNAI, MD, 0326832565, sgennai@chu-reims.fr
Stéphane GENNAI, MD
About this study
Official title: INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS: a Randomized Trial
Urinary tract infections (UTI), mainly driven by Gram-negative bacteria (GNB) are a frequent cause of hospitalization and the second cause of antibiotic prescription after lower respiratory tract infections. Integrons play a major role in the dissemination of antibiotic resistance among GNB. In the prospective INVICTUS project, whose ultimate objective is to reduce the use of large broad-spectrum antibiotics, our hypothesis is that, in adult patients with a non-severe UTI (qSOFA<2) and a former documentation with a 3GC-resistant GNB in the previous 6 months, integrons search could reduce the empirical use of large broad-spectrum antibiotics.
Read the detailed description
The promotor conducted a multicenter prospective study, IRIS (Interest of integrons as predictive markers of acquired antibiotic Resistance in patients with urinary or Intra-abdominal Sepsis) which showed that integrons have a high negative predictive value (NPV) for antibiotic resistance. Among the 343 patients admitted in the ED or intensive care units (ICU) with a urinary sepsis, the NPV of integrons, by detecting them directly form urine samples, was 96.6% (CI:94.0-98.6%) for resistance to 3GC. Whether the detection of integrons to predict antibiotic resistance could efficiently guide empirical antibiotic therapy of patients with a UTI remains to determine. INVICTUS aims at providing the front-line ED physician with additional valuable information using molecular detection of integrons, to best guide adequate first-line antibiotic therapy, while sparing large broad-spectrum antimicrobial agents. In the experimental arm, empirical parenteral antibiotic therapy will be guided based on the detection of integrons. If integrons detection is positive, a large broad spectrum therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) will be prescribed. If integrons detection is negative, patient will receive a parenteral 3GC (Ceftriaxone, Cefotaxime, Ceftazidime or Cefepime). In the control arm, the comparative treatment will be an empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) at clinician's discretion. For the primary analysis, the number of days with large broad-spectrum antibiotic therapy during the first week will be compared between the two groups using a Student t-test.
- Conditions
- Drug Resistance, Microbial, Biomarkers, Urinary Tract Infections (UTI's), Antibacterial Agents
- Being tested
- Detection of integrons, Gold standard
- Keywords
- Integron, Antimicrobial Stewardship, Antimicrobial Resistance, Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of integronsDiagnostic test
Empirical parenteral antibiotic therapy will be guided based on the detection of integrons. If integrons detection is positive, a large broad spectrum therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) will be prescribed. If integrons detection is negative, patient will receive a parenteral 3GC (ceftriaxone, cefotaxime, ceftazidime or cefepime). The treatment will be started after the integron detection.
Gold standardOther
The comparative treatment will be an empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) at clinician's discretion. The treatment will be started after the randomization
| Study group | Role | What they receive |
|---|---|---|
| Empirical parenteral antibiotic therapy based on the detection of integrons | Experimental | In the experimental arm, empirical parenteral antibiotic therapy will be guided based on the detection of integrons. If integrons detection is positive, a large broad spectrum therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) will be prescribed. If integrons detection is negative, patient will receive a parenteral 3GC (ceftriaxone, cefotaxime, ceftazidime or cefepime). The treatment will be started after the integron detection Receives: Diagnostic Test: Detection of integrons |
| Empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations | Active comparator | In the control arm, the comparative treatment will be an empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) at clinician's discretion. The treatment will be started after the randomization Receives: Other: Gold standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with large broad-spectrum antibiotic therapy
Number of days with large broad-spectrum antibiotic therapy (ureidopenicillin and β-lactamases inhibitor combinations or carbapenems) during the first week of treatment (i.e., until Day 7 after admission) in the experimental arm compared to the number of days with large broad-spectrum antibiotic therapy in the control arm
Measured: Day 7
Secondary outcomes (4)
Proportion of patients with clinical resolution of UTI
Proportion of patients with clinical resolution of UTI, i.e. 2 consecutive temperature assessment < 38°C and ≥ 36°C (with a minimum interval of 3 hours) within the first 48 hours after the first parenteral antibiotic administration
Measured: Day 7
Proportion of patients for whom the empirical antibiotic therapy
Proportion of patients for whom the empirical antibiotic therapy was adapted to the AST
Measured: Day 7
Proportion of patients, for whom the integron detection result was consistent with the AST
Proportion of patients, in the experimental arm, for whom the integron detection result was consistent with the AST (i.e., true positives + true negatives, AST being the gold standard)
Measured: Day 7
Proportion of resistant bacteria for the clinically-relevant antibiotics
Proportion of resistant bacteria for the clinically-relevant antibiotics (AST data)
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start20 Sep 2026
- Primary completion26 Sep 2028 (estimated)
- Study completion26 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistance, MicrobialStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, controlled, open, trial
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675018
- Sponsor's protocol ID
- 87RI19_0037 (INVICTUS)
- Other IDs
- ReCH-MIE-24-003, 2026-A00508-43
- Acronym
- INVICTUS
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS: a Randomized Trial
- ClinicalTrials.gov ID
- NCT07675018
- Acronym / sponsor ID
- INVICTUS / 87RI19_0037 (INVICTUS)
- Conditions
- Drug Resistance, Microbial, Biomarkers, Urinary Tract Infections (UTI's), Antibacterial Agents
- Keywords
- Integron, Antimicrobial Stewardship, Antimicrobial Resistance, Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 20 Sep 2026 (actual)
- Primary completion
- 26 Sep 2028 (estimated)
- Study completion
- 26 Sep 2028 (estimated)
- First posted
- 30 Jun 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.
Urinary tract infections (UTI), mainly driven by Gram-negative bacteria (GNB) are a frequent cause of hospitalization and the second cause of antibiotic prescription after lower respiratory tract infections. Integrons play a major role in the dissemination of antibiotic resistance among GNB. In the prospective INVICTUS project, whose ultimate objective is to reduce the use of large broad-spectrum antibiotics, our hypothesis is that, in adult patients with a non-severe UTI (qSOFA<2) and a former documentation with a 3GC-resistant GNB in the previous 6 months, integrons search could reduce the empirical use of large broad-spectrum antibiotics.
Detailed description
The promotor conducted a multicenter prospective study, IRIS (Interest of integrons as predictive markers of acquired antibiotic Resistance in patients with urinary or Intra-abdominal Sepsis) which showed that integrons have a high negative predictive value (NPV) for antibiotic resistance. Among the 343 patients admitted in the ED or intensive care units (ICU) with a urinary sepsis, the NPV of integrons, by detecting them directly form urine samples, was 96.6% (CI:94.0-98.6%) for resistance to 3GC. Whether the detection of integrons to predict antibiotic resistance could efficiently guide empirical antibiotic therapy of patients with a UTI remains to determine. INVICTUS aims at providing the front-line ED physician with additional valuable information using molecular detection of integrons, to best guide adequate first-line antibiotic therapy, while sparing large broad-spectrum antimicrobial agents. In the experimental arm, empirical parenteral antibiotic therapy will be guided based on the detection of integrons. If integrons detection is positive, a large broad spectrum therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) will be prescribed. If integrons detection is negative, patient will receive a parenteral 3GC (Ceftriaxone, Cefotaxime, Ceftazidime or Cefepime). In the control arm, the comparative treatment will be an empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) at clinician's discretion. For the primary analysis, the number of days with large broad-spectrum antibiotic therapy during the first week will be compared between the two groups using a Student t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, controlled, open, trial
| Arm | Type | Receives |
|---|---|---|
| Empirical parenteral antibiotic therapy based on the detection of integrons | Experimental | Diagnostic Test: Detection of integronsIn the experimental arm, empirical parenteral antibiotic therapy will be guided based on the detection of integrons. If integrons detection is positive, a large broad spectrum therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) will be prescribed. If integrons detection is negative, patient will receive a parenteral 3GC (ceftriaxone, cefotaxime, ceftazidime or cefepime). The treatment will be started after the integron detection |
| Empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations | Active comparator | Other: Gold standardIn the control arm, the comparative treatment will be an empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) at clinician's discretion. The treatment will be started after the randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old; Hospitalized or admitted to the Emergency department;
- Diagnosis of non-severe (qSOFA < 2) urinary tract infection coupled with fever ≥ 38°C or < 36°C
- Presence of bacteria in the fresh urine sample and/or GNB on the Gram stain
- Empirical parenteral antibiotic therapy required; Hospitalization required;
- Former documentation of a 3GC-resistant GNB on a microbiological sample in the previous six months
Key exclusion criteria (8 listed)
- Pregnant and/or breastfeeding
- Neutropenia (absolute neutrophil count < 500 / mm3)
- Severe UTI with sepsis (qSOFA ≥ 2) or septic shock
- Urinary derivation required (ureteral catheter/per-cutaneous nephrostomy) except for simple urinary catheterization
- Known allergy to β-lactams
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 |
|---|---|---|
| Detection of integronsEmpirical parenteral antibiotic therapy will be guided based on the detection of integrons. If integrons detection is positive, a large broad spectrum therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) will be prescribed. If integrons detection is negative, patient will receive a parenteral 3GC (ceftriaxone, cefotaxime, ceftazidime or cefepime). The treatment will be started after the integron detection. | Diagnostic test | Empirical parenteral antibiotic therapy based on the detection of integrons |
| Gold standardThe comparative treatment will be an empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations (Piperacillin-Tazobactam) or carbapenems (Imipenem, Meropenem) at clinician's discretion. The treatment will be started after the randomization | Other | Empirical antibiotic therapy with ureidopenicillin and β-lactamase inhibitors combinations |
Primary outcome
Number of days with large broad-spectrum antibiotic therapy
Time frame: Day 7
Number of days with large broad-spectrum antibiotic therapy (ureidopenicillin and β-lactamases inhibitor combinations or carbapenems) during the first week of treatment (i.e., until Day 7 after admission) in the experimental arm compared to the number of days with large broad-spectrum antibiotic therapy in the control arm
4 secondary outcomes
Proportion of patients with clinical resolution of UTI
Time frame: Day 7
Proportion of patients for whom the empirical antibiotic therapy
Time frame: Day 7
Proportion of patients, for whom the integron detection result was consistent with the AST
Time frame: Day 7
Proportion of resistant bacteria for the clinically-relevant antibiotics
Time frame: Day 7
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 30 Oct 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of integrons and Gold standard in people with Drug Resistance, Microbial and Biomarkers, run by University Hospital, Limoges at 7 sites in France.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Contact Olivier BARRAUD, MD (055505665 ext. +33, olivier.barraud@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with large broad-spectrum antibiotic therapy (time frame: Day 7). 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 30 Oct 2026.