Actively Recruiting
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Led by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) · Updated on 2026-04-30
66
Participants Needed
26
Research Sites
108 weeks
Total Duration
On this page
Sponsors
R
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 months to less than 12 years
- Clinically suspected or bacteriologically confirmed complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) requiring hospitalization and at least 3 days of intravenous antibiotics
- Evidence of pyuria confirmed by urine dipstick or microscopic white blood cell count
- Presence of symptomatic or asymptomatic cUTI or AP as specified in the protocol
- Baseline urine specimen obtained for culture by acceptable methods within 48 hours before starting intravenous study drug
- Investigator judgment that hospitalization and 7 to 14 days of antibacterial therapy are required for presumed cUTI treatment
You will not qualify if you...
- History of allergic reaction or hypersensitivity to beta-lactam antibiotics such as cephalosporins, penicillins, carbapenems, or monobactams
- Known infection with Vabomere-resistant gram-negative organisms or gram-positive only infections from qualifying cultures
- Receipt of effective antibacterial drug therapy for cUTI for more than 24 hours in the 72 hours before enrollment, except in cases of treatment failure or resistance
- Undergoing dialysis or estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m²
- Significant liver disease or dysfunction, including acute or chronic hepatitis, hepatic encephalopathy, or elevated liver enzymes above specified limits
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
3
University of Nebraska Medical Center, Department of Pediatrics
Omaha, Nebraska, United States, 68198
Actively Recruiting
4
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
5
Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases
Dupnitsa, Bulgaria, 2600
Actively Recruiting
6
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases
Gabrovo, Bulgaria, 5300
Actively Recruiting
7
Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases
Pazardzhik, Bulgaria
Actively Recruiting
8
University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic
Plovdiv, Bulgaria
Actively Recruiting
9
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics
Rousse, Bulgaria
Actively Recruiting
10
Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven
Sliven, Bulgaria
Actively Recruiting
11
Multiprofile Hospital For Active Treatment, "Vita", Department of Urology
Sofia, Bulgaria
Actively Recruiting
12
University Hospital for Active Treatment and Emergency Medicine (UHATEM) "N. I. Pirogov" LTD, Urology Clinic, Department of Urology
Sofia, Bulgaria
Actively Recruiting
13
University Hospital for Infectious Diseases "Dr. Fran Mihaljevic"
Zagreb, Croatia, 10000
Actively Recruiting
14
JSC Vian
Batumi, Georgia
Actively Recruiting
15
Geo Hospitals LLC
Tbilisi, Georgia, 0144
Actively Recruiting
16
JSC Georgian Clinics
Tbilisi, Georgia, 0159
Actively Recruiting
17
LTD L. Managadze National Center of Urology
Tbilisi, Georgia
Actively Recruiting
18
New Hospitals LLC
Tbilisi, Georgia
Actively Recruiting
19
Vian JSC
Tbilisi, Georgia
Actively Recruiting
20
University Hospital Alexandroupolis, Department of Pediatrics
Alexandroupoli, Greece
Actively Recruiting
21
Agia Sofia Children's Hospital, Infectious Diseases, Pediatrics - General
Athens, Greece, 11527
Actively Recruiting
22
University General Hospital "Attikon", 1 Rimini Str., Chaidari, PC 12462
Athens, Greece
Actively Recruiting
23
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, Greece, 54642
Actively Recruiting
24
Papageorgiou General Hospital
Thessaloniki, Greece
Actively Recruiting
25
St. Jadwiga the Queen Provincial Hospital #2 in Rzeszow, 1st Teaching Department of Pediatrics and Pediatric Gastroenterology, Pediatric Cardiology Subdivision
Rzeszów, Poland, 35-301
Actively Recruiting
26
St. Hedwig of Silesia Hospital in Trzebnica, Pediatric Department with Infantible Sub-department
Trzebnica, Poland, 55-100
Actively Recruiting
Research Team
M
Medical Information Study Director Melinta Therapeutics, LLC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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