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A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

Single Group Phase 2 Study to Investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam Administered by IV Over 2 Hr in Male or Female Participants From Birth to Less Than 18 Years of Age Hospitalised With cUTI

NCT05826990•Allecra

View on ClinicalTrials.gov

Summary

This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for cefepime-enmetazobactam to children with cUTI.

Detailed Description

The purpose of this study is to evaluate the blood concentrations and safety of the fixed dose combination of 2 drugs, cefepime with enmetazobactam administered intravenously in participants aged from birth to less than 18-years of age, hospitalised with a complicated urinary tract infection. The treatment duration will be between 3 and 7 days, depending on the time needed for disappearance of signs and symptoms of the infection. The participant will need to be hospitalised at least during the treatment administration period. After the last administration of cefepime and enmetazobactam, there will be the end of treatment visit (EOT), then 2 follow-up visits at 7 days (Test of Cure (TOC)), then 14 days (Late Follow-up (LFU)) after the end of treatment visit. The End of study Visit (EOS) will be conducted via telephone call (or a visit deemed necessary as per the investigator) 28 days after the EOT visit. The participants may be discharged from hospital at the discretion of the investigator after the end of treatment visit but will be required to return to the hospital for the 2 follow-up visits.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be from birth to \<18 years of age. Participants up to 2 months must have been born at term or preterm with a gestational age ≥32 weeks.
•Written informed consent from parent(s) or other legally acceptable representative(s), and informed assent from participant (if age appropriate according to local regulations).
•If female and has reached menarche, or has reached Tanner stage 3 development, (even if not having reached menarche) the participant is authorized to participate in this clinical study if the following criteria are met:
•1. Participant has a negative urine and/or serum human chorionic gonadotropin test at screening visit. As serum tests may miss an early pregnancy, relevant menstrual history, and sexual history, including methods of contraception, should be considered
•2. Participant agrees to avoid conception from the time of screening until 7 days after receipt of study intervention and agrees not to attempt pregnancy from the time of screening until 7 days after EOT with study intervention, and participant agrees to follow guidelines received regarding continuation of abstinence, initiation of abstinence or about allowed contraception, and
•3. Participant reports sexual abstinence for the prior 3 months or reported the use of at least 1 of the acceptable methods of contraception, including an intrauterine device (with copper banded coil), levonorgestrel intrauterine system or regular medroxyprogesterone injections, or participant agrees to initiate sexual abstinence from the time of screening until 7 days after end of treatment (EOT) with study intervention.
•Participant has a clinically suspected and/or bacteriologically documented complicated urinary tract infection (cUTI) or acute pyelonephritis judged by the investigator to require the participant to be hospitalized for treatment with intravenous (i.v.) therapy.
•The causative pathogen is confirmed or suspected to be susceptible to cefepime-enmetazobactam.
•Participant has pyuria, defined as dipstick analysis positive for leukocyte esterase OR:
•1. If ≥1 year of age: White blood cell (WBC) count \>10 cells/µL in unspun urine or ≥10 cells/high power field in spun urine.
+29 more criteria

Exclusion Criteria

•History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to cefepime, any cephalosporin, penicillins, β-lactamase inhibitors (e.g., tazobactam, sulbactam, or clavulanic acid), or other β-lactam agents.
•Previous enrolment in this study, or in another interventional study ≤30 days before i.v. administration of study intervention.
•Concurrent infection requiring systemic antibiotics in addition to the i.v. study intervention therapy at the time of first study intervention administration.
•Receipt of systemic antibiotics within 24 hours before obtaining the study qualifying pre-treatment baseline urine sample and before study intervention therapy. Exceptions are:
•Receipt up to 24 hours of short-acting antibacterial agent with a daily dose not completed. (Refer protocol ► Section 10.5, Appendix 5 for the list of allowed and disallowed antibiotics).
•* Patients who received prior antimicrobial therapy for the current cUTI/AP, and 1) in the Investigator's opinion, failed that prior antibiotic therapy (i.e., presented with worsening signs and symptoms), AND 2) were documented that the pathogen is non-susceptible to the prior antibiotic therapy.
•* Patients who have received antimicrobial prophylaxis for recurrent cUTI and then presented signs and symptoms consistent with an active new cUTI or AP.
•A permanent indwelling bladder catheter or instrumentation including nephrostomy or current urinary catheter or anticipation of urinary catheter placement that would not be removed during the course of i.v. study intervention therapy administration.
•Participant has suspected or known complete obstruction of any portion of the urinary tract, perinephric abscess, or ileal loops.
•Participant has trauma to the pelvis or urinary tract.
+11 more criteria

Locations (6)

Fakultní nemocnice Hradec Králové -Ústav klinické biochemie a diagnostiky

Hradec Králové, Czechia

Hopital des Enfants

Toulouse, France

Debreceni Egyetem Klinikai Központ Gyermekgyógyászati Klinika

Debrecen, Hungary

SZPZOZ im. Dzieci Warszawy w Dziekanowie Leśnym

Łomianki, Poland

Národný ústav detských chorôb (NÚDCH)

Bratislava, Slovakia

Hospital Universitario La Paz

Madrid, Spain

Key Dates

Start Date

September 11, 2023

Primary Completion Date

September 30, 2025

Completion Date

March 30, 2026

Last Updated

January 12, 2024

Enrollment

ESTIMATED participants

Conditions

Complicated Urinary Tract Infection

Interventions

cefepime and enmetazobactam combination

DRUG

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

NCT04876131

Complicated Urinary Tract InfectionInfection+1 more

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COMPLETEDPHASE2

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

NCT04335539

Gram-negative Bacterial InfectionsBloodstream Infections (BSI)+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

Inclusion Criteria

Exclusion Criteria

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

A Trial of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women