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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05066854
Other study ID # 87RI20_0029 (INVICTUS PED)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 18, 2022
Est. completion date November 18, 2025

Study information

Verified date September 2023
Source University Hospital, Limoges
Contact Christine LAGUILLE, MD
Phone 0555058664
Email christine.laguille@chu-limoges.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 urinary tract infection (UTI) with fever


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 232
Est. completion date November 18, 2025
Est. primary completion date November 18, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Years
Eligibility 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 (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

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
France Bordeaux university Hospital Bordeaux
France Limoges university Hospital Limoges
France Montpellier university Hospital Montpellier
France Toulouse university Hospital Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 30
Secondary patients treated Number of patients treated with 3GC in both groups, during the participation of each patient Day 30
Secondary Duration treatment Duration of treatment with 3GC in both groups for patient treated, during the participation of each patient Day 30
Secondary 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
Hour 48
Secondary 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) Hour 48
Secondary Resistance of enterobacteria In the study population, percentage of resistance of enterobacteria to the different antibiotic classes Hour 48
Secondary Predictive values of the integrons Negative and positive predictive values of the integrons depending on the main antibiotic classes used in the experimental group. Hour 48
Secondary Apyrexia Time to apyrexia from the start of the antibiotic therapy compared between both groups. Hour 48
Secondary Early repetition of urinary tract infection Proportion of early repetition of urinary tract infection with fever in both groups. Day 30
Secondary Treatment interruption for adverse effects Proportion of treatment interruption for adverse effects in both groups. Day 30
Secondary Time spent in the pediatric emergency department Time spent in the pediatric emergency department in both groups Day 30
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