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Cilastatin

Cilastatin is a drug that has been the subject of several clinical trials, often used in combination with other antibiotics to treat various bacterial infections. This article explores the use of cilastatin in clinical trials, focusing on its efficacy, safety, and potential applications in treating conditions such as urinary tract infections, pneumonia, and other bacterial infections.

Table of Contents

What is Cilastatin?

Cilastatin is a medication that is typically used in combination with other antibiotics to treat various bacterial infections. It is not an antibiotic itself, but rather a supportive drug that helps other antibiotics work more effectively[1]. Cilastatin is often referred to by its generic name, but it may also be found as part of combination drugs such as imipenem/cilastatin (brand name: PRIMAXIN®)[2].

How Cilastatin Works

Cilastatin works by preventing the breakdown of certain antibiotics in the kidneys. This allows the antibiotic to remain active in the body for a longer period, increasing its effectiveness against bacterial infections. Specifically, cilastatin inhibits an enzyme in the kidneys called dehydropeptidase-I, which would otherwise break down antibiotics like imipenem[1].

Medical Uses of Cilastatin

Cilastatin is not used on its own to treat infections. Instead, it is combined with other antibiotics to treat various bacterial infections, including:

  • Complicated urinary tract infections (cUTIs): These are infections that affect the bladder, kidneys, or other parts of the urinary system and are more difficult to treat than simple UTIs[2].
  • Complicated intra-abdominal infections (cIAIs): These are infections that extend beyond the hollow organ of origin into the peritoneal space, causing either abscess formation or peritonitis[3].
  • Hospital-acquired bacterial pneumonia (HABP): This is a lung infection that develops during a hospital stay, typically 48 hours or more after admission[4].
  • Ventilator-associated bacterial pneumonia (VABP): This is a type of pneumonia that occurs in people who are on mechanical ventilation[4].

Combination Therapies with Cilastatin

Cilastatin is most commonly used in combination with other antibiotics. Some of the notable combinations include:

  • Imipenem/Cilastatin: This combination is used to treat a wide range of bacterial infections. Imipenem is a powerful antibiotic, and cilastatin helps to prevent its breakdown in the kidneys[2].
  • Imipenem/Cilastatin/Relebactam: This is a newer combination that includes relebactam, which helps to overcome certain types of antibiotic resistance. It’s used for complicated urinary tract infections and complicated intra-abdominal infections[5].

How Cilastatin is Administered

Cilastatin is typically administered intravenously (through a vein) in a hospital or clinical setting. The dosage and duration of treatment can vary depending on the specific infection being treated and the patient’s kidney function. For example:

  • In some studies, imipenem/cilastatin was given as 500mg/500mg every 6 hours[6].
  • In other cases, imipenem/cilastatin/relebactam was administered as 1.25g every 6 hours[3].

The exact dosage and schedule will be determined by your healthcare provider based on your individual needs and medical condition.

Current Clinical Trials

Several clinical trials are currently underway to further investigate the use of cilastatin in various combinations and for different conditions. Some of these include:

  • A study examining the pharmacokinetics (how the drug moves through the body) of imipenem/cilastatin/relebactam in patients receiving extracorporeal membrane oxygenation (ECMO), a life support machine for patients with severe heart and lung failure[7].
  • Research on a new combination therapy called imipenem/cilastatin/XNW4107 for treating hospital-acquired and ventilator-associated bacterial pneumonia[4].

Potential Side Effects

As with any medication, cilastatin and its combinations can cause side effects. Common side effects may include:

  • Nausea or vomiting
  • Diarrhea
  • Headache
  • Rash or itching
  • Changes in liver function tests

More serious side effects, though rare, can occur. These may include severe allergic reactions, seizures, or changes in mental status. It’s important to report any unusual symptoms to your healthcare provider immediately[2].

Special Considerations

There are some important factors to consider when using cilastatin:

  • Kidney function: Since cilastatin affects kidney function, dosage adjustments may be necessary for patients with kidney problems[6].
  • Allergies: Patients with a history of allergic reactions to beta-lactam antibiotics (like penicillins or cephalosporins) should use cilastatin combinations with caution.
  • Pregnancy and breastfeeding: The safety of cilastatin during pregnancy and breastfeeding has not been fully established. Discuss the risks and benefits with your healthcare provider if you are pregnant or breastfeeding.
Aspect Details
Main Uses Cilastatin is primarily used in combination with other antibiotics, especially imipenem, to treat various bacterial infections
Infections Studied Complicated urinary tract infections, hospital-acquired pneumonia, ventilator-associated pneumonia, intra-abdominal infections
Administration Typically administered intravenously in clinical trials
Dosage Varies depending on the specific infection and patient condition
Treatment Duration Ranges from 5 to 14 days in most studies
Safety Monitoring Adverse events, laboratory values, vital signs, and other safety parameters are closely monitored
Potential Benefits May enhance antibiotic effectiveness by preventing kidney breakdown, potentially improving treatment of serious bacterial infections
Ongoing Research Studies are exploring cilastatin’s efficacy, safety, and pharmacokinetics in various patient populations and infection types

FAQ

  • What is cilastatin and how does it work? Cilastatin is a drug often used in combination with other antibiotics, particularly imipenem. It works by inhibiting an enzyme in the kidneys that breaks down imipenem, allowing more of the antibiotic to reach the infection site. This combination is effective against a wide range of bacterial infections.
  • What types of infections are being studied with cilastatin in clinical trials? Clinical trials are investigating the use of cilastatin in combination with other drugs for various infections, including complicated urinary tract infections, hospital-acquired pneumonia, ventilator-associated pneumonia, and intra-abdominal infections.
  • Is cilastatin safe to use? The safety of cilastatin is being evaluated in clinical trials. Most studies monitor for adverse events, changes in laboratory values, and other safety parameters. While generally well-tolerated, like all medications, it may have side effects that are being carefully studied.
  • How is cilastatin administered in clinical trials? In most clinical trials, cilastatin is administered intravenously (through a vein) in combination with other antibiotics. The dosage and duration of treatment vary depending on the specific infection being treated and the patient's condition.
  • What are some potential benefits of using cilastatin in antibiotic treatments? Cilastatin may help enhance the effectiveness of certain antibiotics, particularly imipenem, by preventing their breakdown in the kidneys. This could potentially lead to more effective treatments for serious bacterial infections, including those caused by drug-resistant bacteria.

Ongoing Clinical Trials on Cilastatin

  • Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Greece Hungary Spain

  • Study on the Effectiveness of Clofazimine and Drug Combination for Treating Mycobacterium abscessus Lung Disease in Adult Patients

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study comparing 3-week versus 6-week antibiotic treatment for patients with drained pyogenic liver abscess

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    France

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

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Croatia Czechia France Greece Latvia Slovakia +1

  • Title: Comparison of oral tebipenem pivoxil versus intravenous imipenem-cilastatin in adults with complicated urinary tract infection or acute pyelonephritis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Estonia Greece Hungary Latvia +3

  • Study on the Effectiveness and Safety of Imipenem, Cilastatin, and XNW4107 for Adults with Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

Glossary

  • Cilastatin: A drug used in combination with certain antibiotics to prevent their breakdown in the kidneys, allowing more of the antibiotic to reach the infection site.
  • Imipenem: An antibiotic often used in combination with cilastatin to treat various bacterial infections.
  • Intravenous (IV): A method of administering medication directly into a vein.
  • Complicated Urinary Tract Infection (cUTI): A urinary tract infection that is more difficult to treat, often due to structural abnormalities or other factors that increase the risk of treatment failure.
  • Ventilator-Associated Pneumonia (VAP): A type of lung infection that occurs in people who are on mechanical ventilation breathing machines in hospitals.
  • Hospital-Acquired Bacterial Pneumonia (HABP): Pneumonia that develops during a hospital stay, typically 48 hours or more after admission.
  • Intra-Abdominal Infection: An infection that occurs within the abdomen, which can include infections of the stomach, intestines, or other abdominal organs.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Efficacy: The ability of a drug or treatment to produce the desired effect.

References

  1. https://clinicaltrials.gov/study/NCT03595189
  2. https://clinicaltrials.gov/study/NCT02321800
  3. https://clinicaltrials.gov/study/NCT03293485
  4. https://clinicaltrials.gov/study/NCT05204563
  5. https://clinicaltrials.gov/study/NCT05561764
  6. https://clinicaltrials.gov/study/NCT04787562
  7. https://clinicaltrials.gov/study/NCT04493151