A Multi-Center, Open-Label, Single-Arm, Phase 2 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Vabomere (Meropenem-Vaborbactam) In The Treatment Of Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 12
Healthy Volunteers: f
View:
• Have a clinically suspected and/or bacteriologically documented cUTI or AP judged by the Investigator to require hospitalization for treatment with at least 3 days of IV antibiotics.
• Evidence of pyuria, confirmed by either of the following:
‣ A urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis, or
⁃ A urine specimen with either \> 10 white blood cells (WBCs) per microliter from an unspun urine or \> 5WBCs per high power field from a centrifuged specimen
• Symptomatic or asymptomatic cUTI or AP as specified in the protocol.
‣ Acute Pyelonephritis (qualifying symptoms specified in protocol)
• Have a pretreatment baseline urine specimen obtained for culture by an acceptable method, including suprapubic aspiration (SPA), clean urethral catheterization, in dwelling urethral catheter, or mid-stream clean catch (urine specimens obtained from externally placed urine bags will not be allowed) within 48 hours before the start of the administration of the first dose of IV study drug therapy.
• Must, based on the judgment of the Investigator, require hospitalization initially and 7 to14 days of antibacterial therapy for the treatment of the presumed cUTI.
Locations
United States
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
California
Children's Hospital of Orange County
RECRUITING
Orange
Nebraska
University of Nebraska Medical Center, Department of Pediatrics
RECRUITING
Omaha
Other Locations
Bulgaria
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - 2003 OOD, Department of Pediatric Diseases
RECRUITING
Dupnitsa
Multiprofile Hospital for Active Treatment Dr. Tota Venkova, Gabrovo, Department of Pediatrics Diseases
RECRUITING
Gabrovo
Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases
RECRUITING
Pazardzhik
University Multipurpose Hospital for Active Treatment Sveti Georgi, Pediatrics Clinic
RECRUITING
Plovdiv
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics
RECRUITING
Rousse
Multiprofile Hospital for Active Treatment Dr. Ivan Seliminski, Sliven
RECRUITING
Sliven
Multiprofile Hospital For Active Treatment, Vita, Department of Urology
RECRUITING
Sofia
University Hospital for Active Treatment and Emergency Medicine (UHATEM) N. I. Pirogov LTD, Urology Clinic, Department of Urology
RECRUITING
Sofia
Croatia
University Hospital for Infectious Diseases Dr. Fran Mihaljevic
St. Jadwiga the Queen Provincial Hospital #2 in Rzeszow, 1st Teaching Department of Pediatrics and Pediatric Gastroenterology, Pediatric Cardiology Subdivision
RECRUITING
Rzeszów
St. Hedwig of Silesia Hospital in Trzebnica, Pediatric Department with Infantible Sub-department
RECRUITING
Trzebnica
Contact Information
Primary
Medical Information Study Director Melinta Therapeutics, LLC
medinfo@melinta.com
1-844-633-6568
Time Frame
Start Date:2025-06-03
Estimated Completion Date:2027-07
Participants
Target number of participants:66
Treatments
Experimental: Cohort 1: Age 6 to < 12 years
Participants will receive meropenem-vaborbactam via an intravenous (IV) infusion for a minimum of 3 days, for up to 14 days.~Participants with clinical improvement have the option to switch to an oral antibiotic after Day 3.
Experimental: Cohort 2: Age 2 to < 6 years
Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days.~Participants with clinical improvement have the option to switch to an oral antibiotic after Day 3.
Experimental: Cohort 3: Age 3 months to < 2 years
Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days.~Participants with clinical improvement have the option to switch to an oral antibiotic after Day 3.