A Single Group Treatment, Phase 2 study to investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in Male or Female Participants from birth to less than 18 years of age hospitalized with complicated urinary tract infections (cUTI) including Acute Pyelonephritis (AP).

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518003-22-00

Acronym

AT-202

Enrollment

Registered

2024-12-11

Start date

2023-01-20

Completion date

Unknown

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complicated urinary tract infections including acute pyelonephritis

Brief summary

Cmax, Tmax, AUClast, AUC0-tau (repeat dose) , AUC0-inf , AUCextr, half-life, λz, CL, Vd, Cmin, CLss (repeat dose), Vss (repeat dose), Accumulation ratio (repeat dose), Treatment emergent adverse events including monitoring of adverse events of special interests: o Any increase in ALT or AST >3 times the age-specific upper limit of normal or total bilirubin >2 times ULN. o Clostridium difficile-associated diarrhoea CDAD)/Pseudomembranous colitis o Hypersensitivity reactions, anaphylactic reactions, angioedema o Encephalopathy/ seizures / convulsions//delirium, Laboratory parameters, ECGs, vital signs, and physical examination

Detailed description

Overall success rate (Combined clinical and microbiological success rate), Clinical response, Microbiological response

Interventions

DRUGEXBLIFEP 2 g/0.5 g powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Cmax, Tmax, AUClast, AUC0-tau (repeat dose) , AUC0-inf , AUCextr, half-life, λz, CL, Vd, Cmin, CLss (repeat dose), Vss (repeat dose), Accumulation ratio (repeat dose), Treatment emergent adverse events including monitoring of adverse events of special interests: o Any increase in ALT or AST >3 times the age-specific upper limit of normal or total bilirubin >2 times ULN. o Clostridium difficile-associated diarrhoea CDAD)/Pseudomembranous colitis o Hypersensitivity reactions, anaphylactic reactions, angioedema o Encephalopathy/ seizures / convulsions//delirium, Laboratory parameters, ECGs, vital signs, and physical examination	—

Measure

Time frame

—

Secondary

Measure	Time frame
Overall success rate (Combined clinical and microbiological success rate), Clinical response, Microbiological response	—

Countries

Czechia, France, Hungary, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026