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
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
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
- Age range
- 0–11 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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 \> 5 WBCs per high power field from a centrifuged specimen * Symptomatic or asymptomatic cUTI or AP as specified in the protocol…
Interventions
- DrugMeropenem-Vaborbactam
Administered as specified in the treatment arm
- DrugAntibiotics
Administered as prescribed by the study physician in accordance with local guidelines and regulations.
Locations (26)
- Arkansas Children's HospitalLittle Rock, Arkansas
- Children's Hospital of Orange CountyOrange, California
- University of Nebraska Medical Center, Department of PediatricsOmaha, Nebraska
- University Hospitals Rainbow Babies & Children's HospitalCleveland, Ohio
- Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric DiseasesDupnitsa
- Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics DiseasesGabrovo