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(1R,4S)-4-(5-((S)-2-Iminioimidazolidin-4-Yl)-1,3,4- Oxadiazol-2-Yl)-6-Oxo-5,7- Diazaspiro[Bicyclo[3.2.1]Octane-2,1′-Cyclopropan]-7-Yl Sulfate

This article discusses a clinical trial investigating the use of a new drug called XNW4107 (containing the active substance (1R,4S)-4-(5-((S)-2-Iminioimidazolidin-4-Yl)-1,3,4- Oxadiazol-2-Yl)-6-Oxo-5,7- Diazaspiro[Bicyclo[3.2.1]Octane-2,1′-Cyclopropan]-7-Yl Sulfate) in treating hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The study aims to compare the effectiveness and safety of XNW4107 with a standard treatment for these serious infections.

Table of Contents

What is XNW4107?

XNW4107 is a new antibiotic medication being developed to treat serious bacterial infections in hospitalized patients[1]. Its full chemical name is (1R,4S)-4-(5-((S)-2-IMINIOIMIDAZOLIDIN-4-YL)-1,3,4- OXADIAZOL-2-YL)-6-OXO-5,7- DIAZASPIRO[BICYCLO[3.2.1]OCTANE-2,1′-CYCLOPROPAN]-7-YL SULFATE[1]. This medication is currently being studied in clinical trials and is not yet approved for general use.

Medical Conditions Treated

XNW4107 is being developed to treat two specific types of pneumonia (lung infection) that occur in hospital settings[1]:

  • Hospital-acquired bacterial pneumonia (HABP): This is a lung infection that develops 48 hours or more after being admitted to the hospital. It can also occur within 7 days of being discharged from a healthcare facility.
  • Ventilator-associated bacterial pneumonia (VABP): This is a lung infection that develops in patients who have been on mechanical ventilation (breathing machine) for 48 hours or more.

Both of these conditions are specifically caused by Gram-negative bacteria, which are a particular type of bacteria that can be especially difficult to treat[1].

How XNW4107 Works

XNW4107 is designed to be used in combination with two other antibiotics: imipenem and cilastatin[1]. This combination is intended to enhance the effectiveness of the treatment against difficult-to-treat bacterial infections. The medication works by interfering with the ability of bacteria to build and maintain their cell walls, ultimately leading to the death of the bacteria[1].

Clinical Trial Information

XNW4107 is currently being studied in a Phase 3 clinical trial[1]. This is an advanced stage of research that aims to confirm the effectiveness and safety of the medication. Key points about the trial include:

  • It’s a multicenter study, meaning it’s being conducted at multiple hospitals or medical centers.
  • It’s randomized and double-blind, which means participants are randomly assigned to receive either XNW4107 or a comparison treatment, and neither the patients nor the doctors know which treatment each patient is receiving. This helps ensure unbiased results.
  • The study aims to enroll about 450 patients with HABP or VABP.
  • The main goal is to compare the death rate (from any cause) at 14 days after starting treatment between patients receiving XNW4107 and those receiving a different antibiotic combination.

Administration and Dosage

In the clinical trial, XNW4107 is being administered as follows[1]:

  • It’s given as an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein.
  • The infusion lasts for 30 minutes and is given every 6 hours.
  • The recommended treatment duration is 7 to 14 days, as determined by the doctor based on the patient’s condition.
  • The maximum daily dose being studied is 1 gram, with a maximum total dose of 14 grams over the course of treatment.

Potential Benefits

While the effectiveness of XNW4107 is still being studied, the researchers hope it will provide several benefits[1]:

  • Improved survival rates for patients with HABP and VABP
  • Better clinical outcomes, such as faster recovery from pneumonia symptoms
  • Effective treatment against antibiotic-resistant bacteria, which are becoming increasingly common and difficult to treat

Safety Considerations

As with any medication, XNW4107 may have potential side effects and safety considerations[1]. The clinical trial is designed to carefully monitor patients for any adverse effects. Some important safety points include:

  • The medication is not recommended for patients with severe kidney problems or those on dialysis.
  • It should not be used in patients with a history of seizures or severe liver disease.
  • Patients with known allergies to similar antibiotics (carbapenems or other beta-lactams) should not receive this medication.
  • The safety of this medication in pregnancy and breastfeeding has not been established.

It’s important to note that as XNW4107 is still in the research phase, our understanding of its benefits and risks may change as more information becomes available from the clinical trial.

Aspect Details
Study Type Phase 3, multicenter, randomized, double-blind, comparative
Condition Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP)
Intervention Imipenem/cilastatin-XNW4107 vs. Imipenem/cilastatin/relebactam
Primary Outcome All-cause mortality rate at Day 14
Secondary Outcomes Mortality rates, clinical success, microbiological success, overall success
Participants Approximately 450 adults with HABP/VABP
Treatment Duration 7 to 14 days
Key Inclusion Criteria Age ≥18 years, HABP/VABP diagnosis, suspected Gram-negative infection
Key Exclusion Criteria Severe renal impairment, life expectancy <3 days, certain concomitant medications

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to evaluate the effectiveness and safety of a new drug combination called imipenem/cilastatin-XNW4107 compared to a standard treatment (imipenem/cilastatin/relebactam) in adults with hospital-acquired or ventilator-associated bacterial pneumonia.
  • Who can participate in this study? The study is open to adults (18 years or older) who have been diagnosed with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Gram-negative bacteria. Participants must meet specific criteria related to their condition and overall health status.
  • How long does the treatment last in this trial? The recommended treatment duration in this trial is 7 to 14 days, as determined by the investigator based on the patient's condition and response to treatment.
  • What are the main outcomes being measured in this study? The primary outcome is the all-cause mortality rate at Day 14 after starting treatment. Secondary outcomes include mortality rates at Day 28, clinical success rates, microbiological success rates, and overall success rates at various time points during and after treatment.
  • How is the safety of the new drug being evaluated? The study will assess the safety and tolerability of imipenem/cilastatin-XNW4107 by monitoring adverse events, laboratory test results, and other safety parameters throughout the treatment period and follow-up visits.

Ongoing Clinical Trials on (1R,4S)-4-(5-((S)-2-Iminioimidazolidin-4-Yl)-1,3,4- Oxadiazol-2-Yl)-6-Oxo-5,7- Diazaspiro[Bicyclo[3.2.1]Octane-2,1′-Cyclopropan]-7-Yl Sulfate

  • 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

  • Hospital-acquired bacterial pneumonia (HABP): A type of pneumonia that develops in patients at least 48 hours after being admitted to a hospital or within 7 days after being discharged from a healthcare facility.
  • Ventilator-associated bacterial pneumonia (VABP): A type of pneumonia that occurs in patients who have been on mechanical ventilation for at least 48 hours.
  • Gram-negative bacteria: A class of bacteria that do not retain crystal violet dye in the Gram staining protocol. They are a common cause of serious infections, especially in healthcare settings.
  • Imipenem/cilastatin: A combination antibiotic used to treat various bacterial infections. Imipenem is the active antibiotic, while cilastatin prevents the breakdown of imipenem in the kidneys.
  • XNW4107: The new drug being tested in this trial, which contains the active substance (1R,4S)-4-(5-((S)-2-Iminioimidazolidin-4-Yl)-1,3,4- Oxadiazol-2-Yl)-6-Oxo-5,7- Diazaspiro[Bicyclo[3.2.1]Octane-2,1'-Cyclopropan]-7-Yl Sulfate.
  • Relebactam: A beta-lactamase inhibitor that is combined with imipenem and cilastatin to enhance their effectiveness against certain antibiotic-resistant bacteria.
  • All-cause mortality rate: The proportion of participants who die from any cause during a specified period in the study.
  • Clinical success: The improvement or resolution of signs and symptoms of the infection, as evaluated by the investigator.
  • Microbiological success: The elimination or reduction of the bacteria causing the infection, as determined by laboratory tests.
  • APACHE II score: Acute Physiology and Chronic Health Evaluation II score, a system used to assess the severity of illness in critically ill patients.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-imipenem-cilastatin-and-xnw4107-for-adults-with-hospital-acquired-or-ventilator-associated-bacterial-pneumonia/