A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Ch… (NCT06672978) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
United States, Bulgaria66 participantsStarted 2025-06-03
Plain-language 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).
Who can participate
Age range3 Months – 11 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* 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.
Key Exclusion Criteria:
* History of hypersensitivity or allergic reaction to beta-lactam antibiotics (for example \[e.g.\], cephalosporins, penicillins, carbapenems, monobactams).
* Known Vabomere-resistant gram-negative organism from study-qualifying urine o…
What they're measuring
1
Number of Participants With Adverse Events (AEs)
Timeframe: Up to 28 days
Trial details
NCT IDNCT06672978
SponsorRempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-01
Contact for this trial
Medical Information Study Director Melinta Therapeutics, LLC