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Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis

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What is this study about?

This study focuses on children with complicated urinary tract infection and acute pyelonephritis (a serious kidney infection). The research evaluates a medication called Vabomere, which contains two active substances: meropenem and vaborbactam. This combination medication is given as a solution through an intravenous infusion (delivered directly into a vein).

The main purpose of this research is to examine how safe and well-tolerated Vabomere is when used in children aged between 3 months and 12 years who have these urinary tract infections. During the study, participants will need to stay in the hospital initially and receive the medication through an intravenous infusion for at least 3 days. The total treatment period may last between 7 to 14 days.

Throughout the study, doctors will monitor the children’s health by checking their blood and urine samples, vital signs, and any side effects that may occur. They will also look at how the medication moves through the body and how well it works in treating the infection. The medication will be given at regular intervals, with careful attention to the appropriate dose for each child.

1 Initial hospital admission

You will be admitted to the hospital for treatment of complicated urinary tract infection or acute pyelonephritis (kidney infection).

A urine sample will be collected through catheterization or clean catch method for laboratory testing.

If you cannot sense urinary symptoms due to spinal cord conditions, two urine samples will be taken at least 1 hour apart.

2 Treatment initiation

You will receive Vabomere (meropenem-vaborbactam) through an intravenous infusion (IV line).

The initial IV treatment will last at least 3 days while you stay in the hospital.

The total treatment duration will be 7 to 14 days.

3 Monitoring during treatment

Your blood samples will be collected to measure medication levels.

Regular checks of vital signs will be performed.

Laboratory tests will monitor your blood count, kidney and liver function.

Any side effects will be recorded and assessed.

4 Assessment of treatment response

Your symptoms will be evaluated to determine if they have improved or resolved.

Additional urine samples will be collected to check if the infection has cleared.

If you had a positive blood culture at the start, new blood samples will confirm the infection has been eliminated.

5 Follow-up period

After completing treatment, you will be monitored for any lasting effects.

Final laboratory tests will be performed to ensure return to normal values.

If you are of reproductive age, continue using effective birth control for 7 days after treatment ends.

Who Can Join the Study?

  • Age between 3 months and 12 years. Children aged 3 months to 1 year must have been born after 37 weeks of pregnancy
  • Parent or legal guardian must provide written consent, and child must provide assent if age-appropriate
  • Must have a suspected or confirmed complicated urinary tract infection or kidney infection requiring at least 3 days of hospital treatment with intravenous antibiotics
  • Must show signs of urinary infection through a urine test showing either:
    – Positive test for white blood cells, or
    – More than 10 white blood cells per microliter in fresh urine, or
    – More than 5 white blood cells under microscope in processed urine
  • Must have at least two symptoms if age 2 or older:
    – Fever above 38°C
    – Pain during urination
    – Frequent urination
    – Urgent need to urinate
    – Pain in lower belly or side
    – Loss of bladder control
    – Feeling sick or vomiting
  • For children under 2 years, must have at least two symptoms:
    – Fever above 38°C
    – Poor growth
    – Weight loss
    – Irritability
    – Yellow skin color
    – Belly pain
    – Vomiting
    – Poor feeding
    – Unusual sleepiness
  • Must have at least one complicating factor, such as:
    – Urinary catheter
    – Recent urinary tract surgery
    – Abnormal urinary tract structure
    – History of repeated urinary infections
  • Must provide proper urine sample for testing before starting treatment
  • Must need 7-14 days of antibiotic treatment
  • For adolescents who have reached puberty, must agree to practice abstinence or use highly effective birth control during the study and for 7 days after

Who Cannot Join the Study?

  • Age less than 3 months or more than 12 years
  • Known allergy or severe reaction to Vabomere or similar antibiotics
  • Severe kidney problems that would affect the medication clearance
  • Currently taking medications that could interact with Vabomere
  • Presence of conditions that would interfere with study procedures
  • History of significant medical conditions that could affect study results
  • Participation in another clinical trial within past 30 days
  • Inability to receive intravenous (through the vein) medication
  • Pregnancy or breastfeeding
  • Urinary tract abnormalities that would require surgical intervention
  • Current use of other antibiotics that could affect study results
  • Severe infection requiring intensive care unit treatment
  • Known resistance to study medication
  • Unable to comply with study visits and procedures
  • History of recurring urinary tract infections that required long-term antibiotic treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie Rzeszow Poland

Other Sites

Site Name City Country Status
MBAL Dr. Ivan Seliminski – Sliven AD Sliven Bulgaria
Centre Hospitalier Regional De La Citadelle Liege Belgium
Multiprofile Hospital For Active Treatment Sveti Ivan Rilski 2003 OOD Dupnitsa Bulgaria
Multiprofile Hospital For Active Treatment Pazardzik AD Pazardzhik Bulgaria
Uordvqiqta Mdtzlqztsdvu Huagltxw Fhs Afdqub Tfpnhuvav Aob Eefrkrpsc Mvrtguoi N I Pinnffk Sofia Bulgaria
Gylqlyj Uutxkbwoyy Hukizhbu Ol Leuzkkd Larissa Greece
Hikobuah Udiekeslhzlvp Fgakppiag Jthsjgd Djhu Madrid Spain
Uxarooubjl Gewbalb Heupplqj Or Azlhastcqykkjo Alexandroupoli Greece
Ignxsjvelu Golwwib Hidogvdp Ou Tiyoyantvwcr Thessaloniki Greece
Uqrygxjhvu Gnzmroo Hqpegyzx Axyddog Gkexrre Hrgnysry Ol Wzot Actqbo H Azxn Vsmkfww Chaidari Greece
Ufuvfippwx Mnrxfavvlswu Hbckqkpj Fyv Aimsuo Tyxlnkkvt Spvlg Gwmcqq Eff Plovdiv Bulgaria
Slmduwaevpo Zrrums Ppgmfepjpfq Zwfpaprx Oifyzt Zdfsxxmdyo Ims Djgmem Wplqyzil W Dpxdmdxdwcj Ltotun Łomianki Poland
Gkqeibz Hrriuoed Oz Totphtlaghkt Prsooozphdms Thessaloniki Greece
Kfpykuw Zl Iircihhvvr Byeltoj Dzr Ffqz Mxnsziwtfk Zagreb Croatia
Mefqcksfvesh Hnzftlpy Fai Arlhym Tjpoznokz Dgs Tvhw Vsinmin At Gabrovo Bulgaria
Ncuajkgkyw Pmyjda I Auhd Srqog Athens Greece
Sauhdbl Inp Slq Jyygyjf Sgmvgvxa W Tmcesdslv Sdsaadyydkh Pgmxkgeqb Zqlpau Omtbnb Zzlnwwxpxc Trzebnica Poland
Urjimyzkop Mlpotyhvnocgnkquk Hjbkojop Ftn Aorqsg Tmahpcwzp Kpifa Ap Ruse Bulgaria
Mnxlorijqwws Hbnlhxcv Fzg Artkei Txpmbtixa Vdtq Lizd Sofia Bulgaria
Hcggrkww Ucedufvovmbyp Hb Mhxmcognpjnok Boadilla Del Monte Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.04.2025
Bulgaria Bulgaria
Not recruiting
01.04.2025
Croatia Croatia
Not recruiting
01.04.2025
Greece Greece
Not recruiting
01.04.2025
Poland Poland
Not recruiting
01.04.2025
Spain Spain
Not recruiting
01.04.2025

Trial locations

Investigated Drugs:

Vabomere (meropenem-vaborbactam) is an intravenous antibiotic medication used to treat complicated urinary tract infections, including kidney infections (acute pyelonephritis). It combines two active substances that work together: meropenem (which kills bacteria) and vaborbactam (which helps meropenem work better by preventing bacteria from becoming resistant to it). The medication is given through a vein (intravenous infusion).

Investigated Diseases:

Complicated Urinary Tract Infection (cUTI) – A serious infection affecting any part of the urinary system that is accompanied by structural or functional abnormalities. This condition occurs when bacteria enter and spread through the urinary tract, causing inflammation and infection. The infection is considered “complicated” when there are factors that make the infection more difficult to treat, such as underlying medical conditions or anatomical abnormalities.

Acute Pyelonephritis (AP) – An infection of the kidney tissue and the renal pelvis that develops rapidly. The condition typically begins in the lower urinary tract and moves upward to affect one or both kidneys. It causes inflammation of the kidney tissue and can result in kidney swelling. The infection usually develops when bacteria from the lower urinary tract travel up through the ureters to the kidneys.

Trial ID:
2024-516360-29-00
Protocol code:
ML-VAB-201-3248-2
Trial Phase:
Therapeutic exploratory (Phase II)

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