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Cilastatin Sodium

This article examines the use of Cilastatin Sodium in clinical trials, focusing on its safety profile, efficacy when combined with other drugs, and pharmacokinetic properties. Cilastatin Sodium is often used in combination with antibiotics to treat various bacterial infections and is being studied in different patient populations, including those with renal impairment.

Table of Contents

What is Cilastatin Sodium?

Cilastatin Sodium is a medication that is typically used in combination with other antibiotics, particularly imipenem[1]. It is not an antibiotic itself, but rather a drug that helps enhance the effectiveness of certain antibiotics. Cilastatin Sodium is often referred to simply as “cilastatin” in medical contexts[2].

How Does Cilastatin Sodium Work?

Cilastatin Sodium works by inhibiting an enzyme in the kidneys called dehydropeptidase-I. This enzyme is responsible for breaking down certain antibiotics, particularly imipenem. By inhibiting this enzyme, cilastatin allows the antibiotic to remain active in the body for a longer period, increasing its effectiveness in fighting bacterial infections[1].

Medical Uses of Cilastatin Sodium

Cilastatin Sodium is primarily used in combination with other antibiotics to treat various types of bacterial infections. Some of the specific conditions it may be used to treat include:

  • Complicated Urinary Tract Infections (cUTI): These are urinary tract infections that are more difficult to treat, often due to structural abnormalities or other complicating factors[3].
  • Acute Pyelonephritis: This is a serious kidney infection that often requires hospitalization[3].
  • Hospital-Acquired Bacterial Pneumonia (HABP): This is a type of pneumonia that develops during a hospital stay[4].
  • Ventilator-Associated Bacterial Pneumonia (VABP): This is pneumonia that develops in patients who are on mechanical ventilation[4].
  • Complicated Intra-Abdominal Infections (cIAI): These are infections within the abdomen that are more severe and often require surgical intervention[4].

How is Cilastatin Sodium Administered?

Cilastatin Sodium is typically administered intravenously (IV), meaning it’s given directly into a vein. It’s usually given in combination with other antibiotics, most commonly imipenem. The dosage and duration of treatment can vary depending on the type and severity of the infection, as well as the patient’s kidney function[1].

In clinical trials, the medication has been administered in various ways:

  • As a 60-minute IV infusion, given every 6 hours[1].
  • As a 3-hour IV infusion[2].
  • In combination with imipenem, given every 6 hours for 5 to 21 days, depending on the type of infection being treated[4].

Current Clinical Trials

Several clinical trials are currently being conducted to further study the effectiveness and safety of Cilastatin Sodium in various combinations and for different conditions:

  • A study evaluating the pharmacokinetics (how the drug moves through the body) of Cilastatin in combination with XNW4107 and imipenem in subjects with various degrees of renal function[1].
  • A trial investigating the safety, tolerability, and pharmacokinetic profile of Cilastatin when administered alone in healthy volunteers[2].
  • A study comparing the efficacy and safety of imipenem+cilastatin/relebactam versus colistimethate sodium+imipenem+cilastatin in treating imipenem-resistant bacterial infections[4].

Potential Side Effects and Safety Considerations

As with any medication, Cilastatin Sodium can potentially cause side effects. In clinical trials, researchers closely monitor for adverse events (AEs) and serious adverse events (SAEs). Some potential side effects and safety considerations include:

  • Nephrotoxicity: This refers to toxic effects on the kidneys. Patients’ kidney function is closely monitored during treatment[4].
  • Liver function changes: Researchers monitor for changes in liver enzyme levels[4].
  • Infusion site reactions: As the medication is given intravenously, there may be reactions at the site where the IV is placed[2].
  • Changes in heart rate, blood pressure, and body temperature[2].

It’s important to note that not all patients will experience these side effects, and the benefits of treatment often outweigh the risks for patients with serious bacterial infections.

Use in Special Populations

The use of Cilastatin Sodium may need to be adjusted for certain groups of patients:

  • Patients with kidney problems: The dosage may need to be adjusted based on the patient’s level of kidney function. In clinical trials, different doses are used for patients with various degrees of renal insufficiency[1].
  • Patients on hemodialysis: Special considerations may be needed for patients with end-stage renal disease who are receiving hemodialysis[1].

Always inform your healthcare provider about any medical conditions you have and all medications you’re taking to ensure safe and effective treatment.

Aspect Details
Study Types Phase 1 and Phase 3 clinical trials
Drug Combinations Cilastatin Sodium with Imipenem, XNW4107, Relebactam
Patient Populations Healthy volunteers, patients with various degrees of renal function, patients with bacterial infections
Administration Intravenous infusion, typically over 60 minutes
Primary Outcomes Safety, tolerability, pharmacokinetics, efficacy against bacterial infections
Secondary Outcomes Microbiological response, clinical response, mortality rates
Safety Assessments Adverse events, laboratory tests, vital signs, ECG parameters
Pharmacokinetic Measures AUC, maximum concentration, clearance, volume of distribution, half-life

FAQ

  • What is Cilastatin Sodium used for in clinical trials? Cilastatin Sodium is primarily used in combination with antibiotics like imipenem to treat bacterial infections. It helps prevent the breakdown of imipenem in the kidneys, allowing for more effective treatment of infections such as complicated urinary tract infections and pneumonia.
  • How is Cilastatin Sodium administered in these trials? In the clinical trials, Cilastatin Sodium is typically administered intravenously (IV) in combination with other drugs. The dosage and frequency can vary, but it's often given as an infusion over 60 minutes, with doses adjusted based on the patient's renal function.
  • What are the main safety concerns being studied for Cilastatin Sodium? The trials are assessing various safety aspects, including adverse events, changes in vital signs, laboratory values, and electrocardiogram (ECG) parameters. Special attention is given to potential effects on kidney function and any infusion site reactions.
  • Are there any specific patient groups being studied with Cilastatin Sodium? Yes, several trials are focusing on patients with different degrees of renal function, from normal kidney function to end-stage renal disease. This helps determine how the drug behaves and should be dosed in patients with kidney problems.
  • What are pharmacokinetic studies of Cilastatin Sodium looking at? Pharmacokinetic studies are examining how Cilastatin Sodium is processed in the body. They measure factors like the drug's concentration in plasma and lungs, how quickly it's cleared from the body, and how long it stays active. This information helps determine optimal dosing strategies.

Ongoing Clinical Trials on Cilastatin Sodium

  • Study of pivmecillinam compared to standard antibiotics for treating Escherichia coli urinary tract infection with fever

    Recruiting

    1 1 1
    Investigated drugs:
    Norway Sweden

  • 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 Comparing Cilastatin and Sodium Thiosulfate for Kidney Protection in Patients Undergoing Surgery with Chemotherapy Using Cisplatin

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of antibiotic treatment effectiveness in critically ill patients receiving drug combination therapy

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Bulgaria Czechia Estonia Latvia Lithuania Slovakia

Glossary

  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Intravenous (IV): Administration of a substance directly into a vein.
  • Renal Function: The ability of the kidneys to filter blood and remove waste products.
  • Complicated Urinary Tract Infection (cUTI): A urinary tract infection that has additional factors making it more difficult to treat, such as structural abnormalities or catheterization.
  • Hospital-Acquired Bacterial Pneumonia (HABP): Pneumonia that develops 48 hours or more after hospital admission.
  • Ventilator-Associated Bacterial Pneumonia (VABP): Pneumonia that develops 48 hours or more after endotracheal intubation.
  • Estimated Glomerular Filtration Rate (eGFR): A measure of how well the kidneys are filtering waste from the blood.
  • End-Stage Renal Disease (ESRD): The last stage of chronic kidney disease where the kidneys no longer function well enough to meet the needs of daily life.
  • Area Under the Curve (AUC): A measure of the total exposure to a drug over time.

References

  1. https://clinicaltrials.gov/study/NCT04787562
  2. https://clinicaltrials.gov/study/NCT03595189
  3. https://clinicaltrials.gov/study/NCT06569056
  4. https://clinicaltrials.gov/study/NCT02452047