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Enmetazobactam

This article discusses a clinical trial exploring the use of cefepime-enmetazobactam, a combination drug, in treating complicated urinary tract infections (cUTI) in children. The study aims to evaluate the drug’s safety, effectiveness, and how it behaves in the bodies of young patients, from newborns to teenagers. This research is an important step in potentially expanding treatment options for children with cUTI.

Table of Contents

What is ENMETAZOBACTAM?

ENMETAZOBACTAM is a new medication being studied for the treatment of complicated urinary tract infections (cUTIs) in children. It’s actually a combination of two drugs: cefepime and enmetazobactam. This combination is also known as cefepime-enmetazobactam.[1]

A complicated urinary tract infection is a serious infection that affects the urinary system (kidneys, bladder, ureters, and urethra). It’s called “complicated” because it’s harder to treat than a simple UTI, often due to underlying conditions or problems with the urinary tract.

How is it used?

ENMETAZOBACTAM is given through an intravenous (IV) line, which means it’s delivered directly into the bloodstream through a vein. The medication is administered every 8 hours, and each dose is given over a period of two hours.[1]

Who can receive this treatment?

The current study is looking at the use of ENMETAZOBACTAM in children and teenagers. Specifically, it includes:[1]

  • Children from birth (newborns) up to 18 years old
  • Both boys and girls
  • Patients who are in the hospital with a complicated urinary tract infection

What does the study involve?

The study is designed to help researchers understand more about how ENMETAZOBACTAM works in children’s bodies and how safe it is. Here’s what participants can expect:[1]

  1. Treatment duration: The medication will be given for 3 to 7 days, depending on how quickly the infection improves.
  2. Hospital stay: Patients need to stay in the hospital at least while receiving the treatment.
  3. Follow-up visits: After the treatment ends, there will be several follow-up visits:
    • End of Treatment visit (EOT): Right after the last dose
    • Test of Cure visit (TOC): 7 days after the last dose
    • Late Follow-up visit (LFU): 14 days after the last dose
    • End of Study visit (EOS): 28 days after the last dose (this might be a phone call)

What are the researchers looking at?

The researchers are interested in several aspects of how ENMETAZOBACTAM works in children’s bodies. They’re measuring things like:[1]

  • Pharmacokinetics: This is how the drug moves through the body. It includes:
    • How much of the drug gets into the bloodstream (Cmax)
    • How long it takes to reach its highest level in the blood (Tmax)
    • How long the drug stays in the body (half-life)
    • How the body processes and removes the drug (clearance and volume of distribution)
  • Safety and tolerability: This includes tracking any side effects or adverse events that occur during the study.

Safety and Side Effects

A major focus of this study is to assess the safety of ENMETAZOBACTAM in children. The researchers will be closely monitoring for any side effects or adverse events. They’ll be looking at:[1]

  • How many patients experience any side effects
  • How many side effects are thought to be related to the medication
  • Whether any patients need to stop the treatment due to side effects
  • Any serious side effects that occur

It’s important to note that all medications can have side effects, and part of this study is to understand what side effects might occur with ENMETAZOBACTAM in children.

Effectiveness of the Treatment

While the main goal of this study is to understand how the drug works in children’s bodies and its safety, the researchers are also looking at how well it works to treat the infection. They’ll be assessing:[1]

  • Clinical response: This means checking if the symptoms of the infection have improved.
  • Microbiological response: This involves testing to see if the bacteria causing the infection have been eliminated.
  • Overall success rate: This combines both the clinical and microbiological responses to see how many patients have fully recovered from their infection.

The researchers will check these responses at various points during and after the treatment to see how quickly and effectively ENMETAZOBACTAM works.

Aspect Details
Study Type Phase 2, single group
Participants Children from birth to under 18 years with cUTI
Intervention Cefepime-enmetazobactam combination, IV every 8 hours
Duration 3-7 days of treatment, follow-up until 28 days post-treatment
Primary Outcomes Pharmacokinetics (Cmax, Tmax, AUC, half-life), Safety, Tolerability
Secondary Outcomes Efficacy (clinical and microbiological success rates)

FAQ

  • What is the purpose of this clinical trial? The purpose of this trial is to evaluate the blood concentrations, safety, and tolerability of cefepime-enmetazobactam in children from birth to under 18 years old who are hospitalized with complicated urinary tract infections (cUTI).
  • How is the medication administered in this study? The medication is administered intravenously (through a vein) over a two-hour period, every 8 hours. It's given as a fixed-dose combination of cefepime and enmetazobactam in a 4 to 1 ratio.
  • How long does the treatment last? The treatment duration is between 3 and 7 days, depending on how long it takes for the signs and symptoms of the infection to disappear.
  • What happens after the treatment ends? After the last dose, there's an end of treatment visit, followed by two follow-up visits at 7 and 14 days later. A final phone call or visit occurs 28 days after the end of treatment.
  • What are the main things the researchers are measuring? The researchers are primarily measuring how the drug behaves in the body (pharmacokinetics), including its concentration in the blood over time. They're also closely monitoring the safety and tolerability of the drug by tracking any side effects or adverse events.

Ongoing Clinical Trials on Enmetazobactam

  • Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Hungary Poland Slovakia Spain

Glossary

  • Complicated Urinary Tract Infection (cUTI): A urinary tract infection that is more serious than a simple infection, often involving the kidneys or occurring in patients with other health issues.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Intravenous (IV): A method of administering medication directly into a vein using a needle or tube.
  • Fixed Dose Combination (FDC): A combination of two or more active drugs in a single dosage form, given in a fixed ratio.
  • Cmax: The maximum concentration of a drug in the blood after it's been administered.
  • AUC (Area Under the Curve): A measure of the total exposure to a drug over time.
  • Half-life: The time it takes for the concentration of a drug in the body to decrease by half.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during the use of a medical treatment, whether or not it's caused by the treatment.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • Efficacy: The ability of a treatment to produce the desired beneficial effect.

References