Acute PyelonephritisPhase 2NCT06672978
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
A Phase 2 study testing Meropenem-Vaborbactam and Antibiotics in people with Acute Pyelonephritis and Complicated Urinary Tract Infection, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) at 26 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 months to 11 years
- Conditions the study is for
- Acute Pyelonephritis, Complicated Urinary Tract Infection
- What is being tested?
- Meropenem-Vaborbactam and Antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 26 sitesin 6 countries
- Study dates
- 3 Jun 2025to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 or blood culture, confirmed cUTI or AP only due to gram-positive organism from study-qualifying urine or blood culture, or known or suspected infection with organisms that are not adequately covered by Vabomere (e.g., viral, mycobacterial, fungal).
- Receipt of a potentially effective antibacterial drug therapy for cUTI for a duration of more than 24 hours during the previous 72 hours prior to enrollment. Exceptions: participants with unequivocal clinical evidence of treatment failure (that is, worsening signs and symptoms); urine culture confirms resistance to the initial antibiotic; or the participant developed signs and symptoms of cUTI or AP while on antibiotics for another indication.
- Participants undergoing dialysis or with estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m^2, as calculated using the updated bedside Schwartz formula.
- Evidence of significant hepatic disease or dysfunction, including known acute viral or inactive chronic hepatitis or hepatic encephalopathy, or aspartate aminotransferase or alanine aminotransferase > 3 × upper limit normal (ULN), or total bilirubin > 1.5 × ULN.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
Bulgaria8 sites
Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases
Dupnitsa, 2600
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases
Gabrovo, 5300
Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases
Pazardzhik
University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic
Plovdiv
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics
Rousse
Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven
Sliven
Multiprofile Hospital For Active Treatment, "Vita", Department of Urology
Sofia
University Hospital for Active Treatment and Emergency Medicine (UHATEM) "N. I. Pirogov" LTD, Urology Clinic, Department of Urology
Sofia
Georgia6 sites
JSC Vian
Batumi
Geo Hospitals LLC
Tbilisi, 0144
JSC Georgian Clinics
Tbilisi, 0159
LTD L. Managadze National Center of Urology
Tbilisi
New Hospitals LLC
Tbilisi
Vian JSC
Tbilisi
Greece5 sites
University Hospital Alexandroupolis, Department of Pediatrics
Alexandroupoli
Agia Sofia Children's Hospital, Infectious Diseases, Pediatrics - General
Athens, 11527
University General Hospital "Attikon", 1 Rimini Str., Chaidari, PC 12462
Athens
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, 54642
Papageorgiou General Hospital
Thessaloniki
United States4 sites
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
University of Nebraska Medical Center, Department of Pediatrics
Omaha, Nebraska, 68198
Children's Hospital of Orange County
Orange, California, 92868
Poland2 sites
St. Jadwiga the Queen Provincial Hospital #2 in Rzeszow, 1st Teaching Department of Pediatrics and Pediatric Gastroenterology, Pediatric Cardiology Subdivision
Rzeszów, 35-301
St. Hedwig of Silesia Hospital in Trzebnica, Pediatric Department with Infantible Sub-department
Trzebnica, 55-100
Croatia1 site
University Hospital for Infectious Diseases "Dr. Fran Mihaljevic"
Zagreb, 10000
About this study
Official title: 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
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).
- Being tested
- Meropenem-Vaborbactam, Antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem-VaborbactamDrug
Also called Vabomere
Administered as specified in the treatment arm
AntibioticsDrug
Administered as prescribed by the study physician in accordance with local guidelines and regulations.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Age 6 to < 12 years | Experimental | Participants will receive meropenem-vaborbactam via an 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 or home IV therapy after Day 3. Receives: Drug: Meropenem-Vaborbactam; Drug: Antibiotics |
| Cohort 2: Age 2 to < 6 years | Experimental | 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 or home IV therapy after Day 3. Receives: Drug: Meropenem-Vaborbactam; Drug: Antibiotics |
| Cohort 3: Age 3 months to < 2 years | Experimental | 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 or home IV therapy after Day 3. Receives: Drug: Meropenem-Vaborbactam; Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: Up to 28 days
Secondary outcomes (6)
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 and Day 3: Up to 3 hours post-dose
Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Day 1 and Day 3: Up to 3 hours post-dose
Area Under the Plasma Concentration Curve from Zero to Infinity (AUC0-inf)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start3 Jun 2025
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PyelonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Medical Information, Study director, Melinta Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672978
- Sponsor's protocol ID
- ML-VAB-201-3248-2
- Other IDs
- 75A50123C00022, 2024-516360-29, U1111-1310-7249
- Status last verified
- Sep 2026
- First submitted
- 1 Nov 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06672978
- Acronym / sponsor ID
- ML-VAB-201-3248-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Age 6 to < 12 years | Experimental | Drug: Meropenem-Vaborbactam, Drug: AntibioticsParticipants will receive meropenem-vaborbactam via an 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 or home IV therapy after Day 3. |
| Cohort 2: Age 2 to < 6 years | Experimental | Drug: Meropenem-Vaborbactam, Drug: AntibioticsParticipants 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 or home IV therapy after Day 3. |
| Cohort 3: Age 3 months to < 2 years | Experimental | Drug: Meropenem-Vaborbactam, Drug: AntibioticsParticipants 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 or home IV therapy after Day 3. |
Who may qualify
- Ages
- 3 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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 or blood culture, confirmed cUTI or AP only due to gram-positive organism from study-qualifying urine or blood culture, or known or suspected infection with organisms that are not adequately covered by Vabomere (e.g., viral, mycobacterial, fungal).
- Receipt of a potentially effective antibacterial drug therapy for cUTI for a duration of more than 24 hours during the previous 72 hours prior to enrollment. Exceptions: participants with unequivocal clinical evidence of treatment failure (that is, worsening signs and symptoms); urine culture confirms resistance to the initial antibiotic; or the participant developed signs and symptoms of cUTI or AP while on antibiotics for another indication.
- Participants undergoing dialysis or with estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m^2, as calculated using the updated bedside Schwartz formula.
- Evidence of significant hepatic disease or dysfunction, including known acute viral or inactive chronic hepatitis or hepatic encephalopathy, or aspartate aminotransferase or alanine aminotransferase > 3 × upper limit normal (ULN), or total bilirubin > 1.5 × ULN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meropenem-VaborbactamAlso: VabomereAdministered as specified in the treatment arm | Drug | Cohort 1: Age 6 to < 12 years, Cohort 2: Age 2 to < 6 years, Cohort 3: Age 3 months to < 2 years |
| AntibioticsAdministered as prescribed by the study physician in accordance with local guidelines and regulations. | Drug | Cohort 1: Age 6 to < 12 years, Cohort 2: Age 2 to < 6 years, Cohort 3: Age 3 months to < 2 years |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 28 days
6 secondary outcomes
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)
Time frame: Up to 14 days
Clinical Cure
Time frame: Up to 14 days
Favorable Microbiological Response (Microbiological Eradication)
Time frame: Up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Information study director
Melinta Therapeutics, LLC
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meropenem-Vaborbactam and Antibiotics in people with Acute Pyelonephritis and Complicated Urinary Tract Infection, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) at 26 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Bulgaria, Georgia, Greece, United States, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.