The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Administered as specified in the treatment arm
Administered as prescribed by the study physician in accordance with local guidelines and regulations.
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Orange County
Orange, California, United States
University of Nebraska Medical Center, Department of Pediatrics
Omaha, Nebraska, United States
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases
Dupnitsa, Bulgaria
Number of Participants With Adverse Events (AEs)
Time frame: Up to 28 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 and Day 3: Up to 3 hours post-dose
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 and Day 3: Up to 3 hours post-dose
Area Under the Plasma Concentration Curve from Zero to Infinity (AUC0-inf)
Time frame: Day 1 and Day 3: Up to 3 hours post-dose
Overall Response (OR)
OR as assessed by the combined per-participant clinical cure and favorable microbiological response.
Time frame: Up to 14 days
Clinical Cure
Clinical cure is defined as the complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline, no new symptoms, and participant is alive.
Time frame: Up to 14 days
Favorable Microbiological Response (Microbiological Eradication)
Favorable microbial response is defined as the reduction of baseline pathogen(s) (\< 10\^3 colony-forming units per milliliter \[CFU/mL\] and at least 1-log reduction from baseline) or negative urine culture, negative repeated blood culture if blood culture was positive for pathogen(s) growth at baseline, and participant is alive.
Time frame: Up to 14 days
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Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases
Gabrovo, Bulgaria
Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases
Pazardzhik, Bulgaria
University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic
Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics
Rousse, Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven
Sliven, Bulgaria
...and 16 more locations