A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participa… (NCT05826990) | Clinical Trial Compass
UnknownPhase 2
A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI
Czechia, France, Hungary40 participantsStarted 2023-09-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
✓. 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.
✓. 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.
✓. If \<1 year of age: WBC count \>5 cells/µL in unspun urine or ≥5 cells/high power field in spun urine.
Exclusion criteria
✕. Haematocrit \<25% or haemoglobin \<8 g/dL (\<80 g/L, \<4.9 mmol/L) for children ≥ 1 month, or \<13 g/dL (\<130 g/L, \<8.0 mmol/L) for children \< 1 month.
✕. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>3 times the age-specific upper limit of normal (ULN), or total bilirubin \>2 times ULN (except known Gilbert's disease) and Absolute Neutrophil count\<1000/ mm3.
What they're measuring
1
Pharmacokinetics Cmax
Timeframe: Day 1 - Day 2
2
Pharmacokinetics Tmax
Timeframe: Day 1 - Day 2
3
Pharmacokinetics AUC0-tau
Timeframe: Day 1 - Day 2
4
Pharmacokinetics AUC0-inf
Timeframe: Day 1 - Day 2
5
Pharmacokinetics t1/2
Timeframe: Day 1 - Day 2
6
Pharmacokinetics CL & Vd
Timeframe: Day 1 - Day 2
7
Pharmacokinetics Cmin
Timeframe: Day 1 - Day 2
8
Safety and Tolerability
Timeframe: before 1st study intervention until EOT +28 Days (±5 Days)
9
Safety and Tolerability
Timeframe: before 1st study intervention until EOT +28 Days (±5 Days)