Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants with Bacterial Pneumonia (XNW4107-302, REITAB-2)

Launched by EVOPOINT BIOSCIENCES INC. · Jan 10, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two antibiotics for treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VAPB). The study is looking at whether a new combination of medications, Imipenem/Cilastatin-XNW4107 (IMI-XNW4107), works just as well as the standard treatment, which is Imipenem/Cilastatin/Relebactam (IMI/REL), in preventing death from these infections. The trial is currently recruiting participants aged 65 and older who meet specific criteria, such as showing symptoms of pneumonia after being in the hospital for more than two days or after starting mechanical ventilation.

If you or a loved one are considering joining this trial, participants will receive either of the two treatments through an intravenous (IV) line. To be eligible, individuals must have confirmed bacterial pneumonia and certain lab results, but should not have had previous effective antibiotic treatment for the infection. It's important to note that there are some exclusion criteria, such as having a severe allergy to certain antibiotics or being pregnant. Overall, this trial aims to find a safe and effective way to treat these serious lung infections, and participants will be closely monitored throughout the study.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Has HABP or VABP as defined below and requires treatment with IV antibiotic therapy. Fulfills clinical criteria, with onset of criteria occurring after more than 48 hours of hospitalization or within 7 days after discharge from a hospital (for HABP); or at least 48 hours after mechanical ventilation (for VABP)
• • 2. Fulfills clinical criteria with symptoms or signs of cough, expectorated sputum production, dyspnea, worsening oxygenation, increase in respiratory secretions, fever/ hypothermia..
• • 3. Fulfills laboratory test criteria with Leukocytosis/ Leukocytosis/ increase in immature neutrophils
• • 4. Fulfill radiograph criteria with presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia in X-ray/ Chest CT.
• • 5. Female subjects of childbearing potential, who are willing to birth control during the study and for at least 30 days following the last dose of study medication. Male subjects with female sexual partners of childbearing potential are eligible for inclusion if they agree to use birth control for 90 days following the last dose of study medication. Male subjects must agree not to donate sperm
• Exclusion Criteria:
• • 1. Gram stain from a respiratory sample shows only Gram-positive cocci.
• • 2. Have known or suspected community-acquired bacterial pneumonia, atypical pneumonia, viral pneumonia including Coronavirus disease, or chemical pneumonia.
• • 3. Have HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction.
• • 4. Have received effective antibacterial drug therapy for the index infection of HABP/VABP for more than 24 hours during the previous 72 hours .
• • 5. Have central nervous system infection.
• • 6. Documented presence of immunodeficiency or an immunocompromised condition
• • 7. Documented or severe hypersensitivity or previous severe adverse drug reaction, especially to any beta-lactam antibiotics, or any of the excipients used in the study drug formulations.
• • 8. History of a seizure disorder requiring ongoing treatment with anti-convulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years.
• • 9. eGFR \<15 mL/min/1.73㎡.
• • 10. Patient is receiving hemodialysis or peritoneal dialysis.
• • 11. Anticipated to be treated with any of Valproic acid or divalproex sodium, concomitant systemic Gram-negative antibacterial agents, or concomitant systemic antifungal or antiviral therapy for the index infection of HABP/VABP.
• • 12. Life expectancy is \<3 days.
• • 13. Patients in refractory septic shock
• • 14. Patients with 1 or more of laboratory abnormalities in baseline specimens.
• • 15. History of active liver disease or cirrhosis.
• • 16. APACHE II score of \>30.
• • 17. A female who is pregnant or breastfeeding or has a positive pregnancy test at Screening.