AzTrials
AzTrials

Urinary Tract Infections in ChildrenINVICTUS PEDNCT05066854

INterest of the Negative Predictive Value of Integrons in Choosing a Narrow-spectrum Empirical anTibiotic Treatment vs Usual Empirical Antibiotic Treatment for Urinary Tract infectionS in the PEDiatric Emergency Department

A study testing integron research and usual practice in people with Urinary Tract Infections in Children, run by University Hospital, Limoges at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

INVICTUS PED primary objective is to show the non-inferiority of an empirical antibiotic therapeutic management guided by the early detection of integrons in the urine, compared to a usual empirical antibiotic treatment, for the recovery of children admitted to the pediatric emergency department (ED) with a non-severe… Read more about this study

Who is it for?
Ages 3 months to 18 years
Conditions the study is for
Urinary Tract Infections in Children
What is being tested?
integron research and usual practice
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
4 sitesFrance
Study dates
18 Oct 2022to 17 Nov 2025
Phase
Interventional
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 3 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children above 3 months old and under 18 years old
  • Consultation in a participating pediatric emergency department
  • Suspicion of UTI with fever (Fever ≥ 38°C and urine dipstick test positive for leukocytes and/or nitrites)
  • First episode of UTI with fever
  • Written informed consent of the holders of parental authority
  • Affiliated to Social Security

Who cannot join

  • Criteria of severity:
  • Severe infection with severe sepsis or septic shock
  • Dehydration ≥ 10%
  • Fever ≥ 38°C > 4 days (96h)
  • Indication of surgical or interventional drainage
  • Complication risk factors:
Show all 20Show fewer
  • Any anatomic or functional defect of the urinary tract (other than low-grade VUR and calyceal dilation < 10 mm)
  • Repetition of UTI with fever ≤ than 6 months since the previous episode
  • Repetition of UTI with fever and anatomic or functional defect of the urinary tract
  • Pregnancy
  • Severely immunocompromised patient
  • Severe chronic renal failure defined as a clearance < 30 mL/min/1.73 m2
  • Severe liver failure
  • 3GC allergy
  • Contra-indication to SXT:
  • G6PD deficiency
  • Treatment with methotrexate
  • Allergy to sulfonamide
  • Antibiotic treatment within 48h before admission
  • Empirical antibiotic treatment not recommended

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Bordeaux university Hospital

    Bordeaux, 33000

  • Limoges university Hospital

    Limoges, 87042

  • Montpellier university Hospital

    Montpellier, 34000

  • Toulouse university Hospital

    Toulouse, 31000

Other trials in France

About this study

INVICTUS PED primary objective is to show the non-inferiority of an empirical antibiotic therapeutic management guided by the early detection of integrons in the urine, compared to a usual empirical antibiotic treatment, for the recovery of children admitted to the pediatric emergency department (ED) with a non-severe urinary tract infection (UTI) with fever

Read the detailed description

Urinary tract infections with fever are common in children and require primary health care management. Because of the risk of immediate evolution to a systemic infection with long-term renal scars, empirical antibiotic treatment is recommended. The French Group for Pediatric Infectious Diseases (GPIP) recommends the use of third-generation cephalosporins (3GC) targeting enterobacteria, which are mainly involved in UTI and increasingly resistant to antibiotics through the production of extended-spectrum β-lactamases. However, use of 3GC is a well-known risk factor for resistant germs selection and one of the main guideline to fight antibiotic resistance, which is an important public health issue, is to reduce their use. Integrons are genetic elements involved in the spread of antibiotic resistance in enterobacteria. Preliminary studies showed that integron search using polymerase chain reaction (PCR) directly on urine samples had a great NPV (>98%) for trimethoprim-sulfamethoxazole (SXT). The hypothesis is that, in children presenting to the pediatric ED with non-severe UTI with fever, absence of integron in their urine could allow prescribing an empirical antibiotic treatment with SXT without decreasing the chance of recovery, thus decreasing the use of 3GC.

Two strategies is compare: i) In the control group: empirical antibiotic treatment according to the usual practice of each center, in line with the GPIP guidelines, ii) in the experimental group: empirical antibiotic treatment chosen depending on the results of the integron search with PCR. When PCR is positive, treatment according to usual practice; when PCR is negative, treatment with SXT.

Two follow-up visits, by phone, will be planned: at H48 (+ 24h), when the empirical antibiotic treatment is assessed based on the urine culture and antimicrobial susceptibility test (AST) results, and on D30 (+/- 2 days) at the end of the follow-up.

Being tested
integron research, usual practice
Keywords
empirical antibiotic treatment, biomarker, urinary tract infection, antibiotic resistance, pediatric emergency department
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.

  • integron researchProcedure or surgery

    Patients with suspected UTI with fever will be screened at their admission to the pediatric ED.

    Urine samples will be sent to the laboratory for culture and integron PCR according to routine practice.

    Results of the integron search will be given to the investigator. Patients in the experimental group with a positive or uninterpretable PCR will also receive an empirical antibiotic treatment based on the usual practice of each center according to the GPIP guidelines.

    Patients in the experimental group with a negative PCR will receive a treatment with SXT at the recommended dose.

  • usual practiceProcedure or surgery

    Patients with suspected UTI with fever will be screened at their admission to the pediatric ED.

    Patients in the control group will receive an empirical antibiotic treatment based on the usual practice of each center according to the GPIP guidelines.

Study groups in NCT05066854
Study groupRoleWhat they receive
Integron researchExperimentalEmpirical antibiotic treatment chosen based on the results of the integron search: * when PCR is negative, patients will receive SXT (30 mg/kg/j of sulfamethoxazole and 6 mg/kg/j of trimethoprim) * when PCR is positive or uninterpretable for integrons, patients will receive an empirical antibiotic treatment based on the usual practice of each center according to the GPIP guidelines.
Receives: Procedure: integron research
Usual practiceOtherEmpirical antibiotic treatment based on the usual practice of each center according to the GPIG guidelines.
Receives: Procedure: usual practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recovery

    Recovery defined as, apyrexia obtained within less than 72h and no persistence or repetition of UTI with fever and no change of empirical antibiotic therapy required because of resistance and no treatment interruption for adverse effects

    Measured: Day 30

Secondary outcomes (10)

  1. patients treated

    Number of patients treated with 3GC in both groups, during the participation of each patient

    Measured: Day 30

  2. Duration treatment

    Duration of treatment with 3GC in both groups for patient treated, during the participation of each patient

    Measured: Day 30

  3. Antibiotic treatment changes

    In both groups, description of antibiotic treatment changes based on the AST results, according to 4 criteria:

    • Change because of resistance
    • Narrowing of the antibiotic spectrum
    • Interruption because the diagnosis of UTI was ruled out
    • Antibiotics used

    Measured: Hour 48

  4. Adaptation of antibiotherapy with the AST result

    Proportion of patients in both groups for whom empirical antibiotic treatment was adapted to the AST results and did not require any change (because of resistance, or to narrow the antibiotic spectrum)

    Measured: Hour 48

  5. Resistance of enterobacteria

    In the study population, percentage of resistance of enterobacteria to the different antibiotic classes

    Measured: Hour 48

  6. Predictive values of the integrons

    Negative and positive predictive values of the integrons depending on the main antibiotic classes used in the experimental group.

    Measured: Hour 48

  7. Apyrexia

    Time to apyrexia from the start of the antibiotic therapy compared between both groups.

    Measured: Hour 48

  8. Early repetition of urinary tract infection

    Proportion of early repetition of urinary tract infection with fever in both groups.

    Measured: Day 30

  9. Treatment interruption for adverse effects

    Proportion of treatment interruption for adverse effects in both groups.

    Measured: Day 30

  10. Time spent in the pediatric emergency department

    Time spent in the pediatric emergency department in both groups

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start18 Oct 2022
  3. Primary completion17 Nov 2025
  4. Study completion17 Nov 2025

Why it stopped: Not enough patients

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05066854
Sponsor's protocol ID
87RI20_0029 (INVICTUS PED)
Acronym
INVICTUS PED
Status last verified
Nov 2025
First submitted
16 Sep 2021
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing integron research and usual practice in people with Urinary Tract Infections in Children, run by University Hospital, Limoges at 4 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 20 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: stopped early, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study was stopped early (reason given: Not enough patients). Results are not available in the source record.

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?

Recovery (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05066854.

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 26 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in