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Vaborbactam

Clinical trials investigating Vaborbactam are studying how it performs in different patient groups, especially children and patients with serious infections. These studies look at safety, tolerability, treatment effect, and how the body handles the drug combination used in the trials.

Table of Contents

Clinical trial overview

The trial data on Vaborbactam includes four authorised interventional studies. Two studies are in Phase 2 and two are in Phase 3, showing that the research ranges from early safety and body-handling questions to larger comparison studies.[1][2][3][4]

These studies focus on people with serious infections, including children and adults, and they look at outcomes such as safety, tolerability, pharmacokinetics, and treatment success.[1][2][3][4]

Pediatric studies

One Phase 2 study is in children aged 3 months to under 12 years with complicated urinary tract infection, including acute pyelonephritis, which is a kidney infection that starts in the urinary tract.[1]

This study has 74 planned participants and checks safety and tolerability based on adverse events, serious adverse events, special safety events, laboratory changes, and vital sign changes from baseline, which means changes compared with the first study visit.[1]

Another Phase 2 study looks at paediatric participants from birth to under 18 years with suspected or confirmed Gram negative infections.[4]

This study includes 44 participants and measures pharmacokinetic values such as AUC, Cmax, Tmax, clearance, half-life, Cmin, and steady-state volume of distribution, which help show how the treatment moves through the body over time.[4]

Adult infection studies

One Phase 3 study, called MODIFY, includes patients with severe infections and has 190 planned participants.[3]

The main goal is to reduce the number of days patients receive broad-spectrum antibiotics, meaning antibiotics that cover many kinds of bacteria, compared with standard care.[3]

Another Phase 3 study, SHORTEN-2, includes 306 participants with bacteremia caused by Pseudomonas aeruginosa, which means bacteria are present in the blood.[2]

This study compares 7 days versus 14 days of antibiotic treatment and uses a DOOR/RADAR analysis, a method that combines benefit and harm into one overall ranking of outcome.[2]

What the trials measure

The pediatric urinary infection study measures adverse events, serious adverse events, laboratory results, and vital signs to see whether the treatment is safe and well tolerated in children.[1]

The pediatric Gram negative infection study measures pharmacokinetic endpoints, including AUC, Cmax, Tmax, CL, t1/2, Cmin, and Vss, to understand exposure in the body after repeated intravenous dosing.[4]

The MODIFY study measures the number of days under broad-spectrum antibiotic treatment, comparing the strategy used in the trial with standard care.[3]

The SHORTEN-2 study measures days of antibiotic treatment and the DOOR score category at day 30 after appropriate antibiotic treatment ends.[2]

Trial design and phases

All four studies are interventional, meaning researchers give a treatment and then observe what happens.[1][2][3][4]

The Phase 2 studies are mainly focused on safety and pharmacokinetics in children, while the Phase 3 studies compare treatment strategies in larger groups of patients with serious infections.[1][2][3][4]

Key points for patients

  • The research on Vaborbactam is focused on serious infections and includes both children and adults.[1][2][3][4]
  • Two studies look mainly at safety and how the body handles the treatment in children.[1][4]
  • Two Phase 3 studies look at treatment length and overall outcomes in adults with severe infections or bacteremia.[2][3]
  • The main study measures include side effects, lab tests, blood pressure and other vital signs, and pharmacokinetic values.[1][4]
Trial ID Phase Condition studied Status Enrollment
2024-516360-29-00 Phase 2 Complicated urinary tract infection, acute pyelonephritis Authorised 74
NCT06828848 Phase 2 Suspected or confirmed Gram negative infections Authorised 44
2022-502962-26-00 Phase 3 Severe infections Authorised 190
NCT05210439 Phase 3 Bacteremia caused by Pseudomonas aeruginosa Authorised 306

FAQ

  • Who can take part in Vaborbactam clinical trials? The trials listed include children from 3 months to under 12 years with complicated urinary tract infection, and paediatric participants from birth to under 18 years with suspected or confirmed Gram negative infections. Other trials study adults with severe infections or bacteremia caused by Pseudomonas aeruginosa.
  • What are the Vaborbactam trials trying to find out? They are checking safety, tolerability, and pharmacokinetics, which means how the body absorbs, changes, and removes the treatment. Some trials also study treatment length and whether shorter antibiotic courses can work as well as longer ones.
  • What trial phases are included? The trial data includes Phase 2 and Phase 3 studies. Phase 2 studies often focus on safety and how the treatment behaves in the body, while Phase 3 studies compare treatment strategies in larger groups.
  • What conditions are being studied? The studies include complicated urinary tract infection, acute pyelonephritis, suspected or confirmed Gram negative infections, severe infections, and bacteremia caused by Pseudomonas aeruginosa.
  • What kinds of results are measured in these trials? The trials measure adverse events, laboratory changes, vital signs, pharmacokinetic values such as AUC and Cmax, and clinical outcomes like days of antibiotic treatment and ranking of overall outcome at follow-up.

Ongoing Clinical Trials on Vaborbactam

  • Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Italy Poland Spain

  • Study on the Effectiveness and Safety of 7 vs. 14 Days of Antibiotic Treatment with Meropenem for Patients with Pseudomonas Aeruginosa Blood Infection

    Recruiting

    1 1 1 1
    Investigated drugs:
    Spain

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

    Not recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria Croatia Greece Poland Spain

  • Study on Avibactam and Drug Combination for Treating Severe Infections in Patients

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece

Glossary

  • Clinical trial: A research study in people that tests a treatment, a strategy, or a diagnostic approach.
  • Interventional study: A study where researchers give a treatment or strategy and then measure what happens.
  • Phase 2: An early or mid-stage trial that often looks closely at safety and how the treatment behaves in the body.
  • Phase 3: A larger trial that compares treatments or strategies to learn which works better in real patient groups.
  • Safety: How well a treatment is tolerated and whether unwanted medical problems happen.
  • Tolerability: How manageable a treatment is for patients, including how well it is accepted by the body.
  • Pharmacokinetics: How the body takes in, moves, and removes a treatment.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Serious adverse event: A more severe unwanted medical problem, such as one that needs hospital care or causes major harm.
  • Gram negative infection: An infection caused by a group of bacteria that are identified in a laboratory test.
  • Bacteremia: Bacteria in the blood.
  • Complicated urinary tract infection: A urinary infection that is more difficult to treat or linked to other medical problems.

References