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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 (INVICTUS PED)

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ClinicalTrials.gov Identifier: NCT05066854
Recruitment Status : Not yet recruiting
First Posted : October 4, 2021
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief 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 urinary tract infection (UTI) with fever

Condition or disease Intervention/treatment Phase
Urinary Tract Infections in Children Procedure: integron research Procedure: usual practice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Integron research

Empirical 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.
Procedure: integron research

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 practice
Empirical antibiotic treatment based on the usual practice of each center according to the GPIG guidelines.
Procedure: usual practice

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.





Primary Outcome Measures :
  1. Recovery [ Time Frame: Day 30 ]
    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


Secondary Outcome Measures :
  1. patients treated [ Time Frame: Day 30 ]
    Number of patients treated with 3GC in both groups, during the participation of each patient

  2. Duration treatment [ Time Frame: Day 30 ]
    Duration of treatment with 3GC in both groups for patient treated, during the participation of each patient

  3. Antibiotic treatment changes [ Time Frame: Hour 48 ]

    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

  4. Adaptation of antibiotherapy with the AST result [ Time Frame: Hour 48 ]
    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)

  5. Resistance of enterobacteria [ Time Frame: Hour 48 ]
    In the study population, percentage of resistance of enterobacteria to the different antibiotic classes

  6. Predictive values of the integrons [ Time Frame: Hour 48 ]
    Negative and positive predictive values of the integrons depending on the main antibiotic classes used in the experimental group.

  7. Apyrexia [ Time Frame: Hour 48 ]
    Time to apyrexia from the start of the antibiotic therapy compared between both groups.

  8. Early repetition of urinary tract infection [ Time Frame: Day 30 ]
    Proportion of early repetition of urinary tract infection with fever in both groups.

  9. Treatment interruption for adverse effects [ Time Frame: Day 30 ]
    Proportion of treatment interruption for adverse effects in both groups.

  10. Time spent in the pediatric emergency department [ Time Frame: Day 30 ]
    Time spent in the pediatric emergency department in both groups



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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    • Any 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

Information from the National Library of Medicine

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): NCT05066854


Contacts
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Contact: Christine LAGUILLE, MD 0555058664 ext +33 christine.laguille@chu-limoges.fr

Locations
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France
Bordeaux university Hospital
Bordeaux, France, 33000
Contact: Marion FAVIER, MD         
Principal Investigator: Marion FAVIER, MD         
Limoges university Hospital
Limoges, France, 87042
Contact: Christine LAGUILLE, MD    0555058664 ext +33    christine.laguille@chu-limoges.fr   
Principal Investigator: Christine LAGUILLE, MD         
Montpellier university Hospital
Montpellier, France, 34000
Contact: Brigitte BLANC, MD         
Principal Investigator: Brigitte BLANC, MD         
Toulouse university Hospital
Toulouse, France, 31000
Contact: Camille BREHIN, MD         
Principal Investigator: Camille BREHIN, MD         
Sponsors and Collaborators
University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT05066854    
Other Study ID Numbers: 87RI20_0029 (INVICTUS PED)
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
empirical antibiotic treatment
biomarker
urinary tract infection
antibiotic resistance
pediatric emergency department
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Emergencies
Disease Attributes
Pathologic Processes
Urologic Diseases