What side effects are associated with this type of intervention?

Common treatments for bacterial pneumonia, particularly broad-spectrum beta-lactam antibiotics like imipenem, often cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. Allergic reactions, including rashes and anaphylaxis, are also possible. Neurotoxic effects, such as seizures, can occur, especially in patients with renal impairment. Cilastatin, used to prevent renal degradation of imipenem, is generally well-tolerated but can contribute to the overall side effect profile.

What prior FDA approvals exist?

The FDA has approved several treatments for bacterial pneumonia that are similar to the Imipenem/Cilastatin-XNW4107 combination. Imipenem/Cilastatin (Primaxin) itself is an approved treatment for severe bacterial infections, including pneumonia. Another related drug is Imipenem/Cilastatin/Relebactam (Recarbrio), which includes a beta-lactamase inhibitor to enhance efficacy against resistant bacteria. These combinations leverage the broad-spectrum activity of Imipenem, the protective effect of Cilastatin on the kidneys, and the addition of beta-lactamase inhibitors to combat resistant strains.

What other types of research exist?

Promising alternatives to Imipenem/Cilastatin-XNW4107 for bacterial pneumonia treatment include Ceftazidime-Avibactam and Ceftolozane-Tazobactam. Both combinations have shown efficacy against a broad spectrum of Gram-negative bacteria, including resistant strains. Additionally, Daptomycin has been effective in treating Gram-positive infections, including those caused by Staphylococcus aureus. These alternatives offer robust options for managing bacterial pneumonia, especially in cases involving resistant pathogens.

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Other

Drug Combinations for Bacterial Pneumonia (REITAB-2 Trial)

Phase 3

Recruiting

Research Sponsored by Sinovent Pty Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fulfills clinical criteria with symptoms or signs of cough, expectorated sputum production, dyspnea, worsening oxygenation, increase in respiratory secretions, fever/ hypothermia

Be older than 18 years old

Must not have

Have HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction

Patients in refractory septic shock

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at late follow-up (lfu), up to 31 days

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

Summary

This trial is testing two antibiotic combinations to treat severe lung infections acquired in hospitals or through ventilators. The antibiotics work by breaking down the bacteria's protective walls, helping to clear the infection.

Who is the study for?

This trial is for adults with hospital-acquired or ventilator-associated bacterial pneumonia who need IV antibiotics. They must have symptoms like cough, fever, and changes on chest X-rays suggestive of pneumonia. Women of childbearing age and men with partners must agree to use birth control during the study.

What is being tested?

The study compares two antibiotic treatments for bacterial pneumonia: Imipenem/Cilastatin combined with XNW4107 versus Imipenem/Cilastatin/Relebactam. The goal is to see if the first combination is just as effective in reducing death rates as the second.

What are the potential side effects?

Possible side effects include allergic reactions, gastrointestinal issues (like diarrhea), blood abnormalities, potential kidney or liver problems, and seizures in those at risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have symptoms like coughing, difficulty breathing, or fever.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung infection due to blockage, possibly from lung cancer.

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I am in a severe, unresponsive state of septic shock.

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My kidney function is very low.

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I am currently on dialysis.

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I am not pregnant, breastfeeding, or have a positive pregnancy test.

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I have an infection in my brain or spinal cord.

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I am expected to be treated with specific medications for a lung infection.

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I have a history of liver disease or cirrhosis.

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I have or might have pneumonia, including from COVID-19 or chemicals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at late follow-up (lfu), up to 31 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at late follow-up (lfu), up to 31 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at late follow-up (lfu), up to 31 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Day 14 all-cause mortality rate

Secondary study objectives

Day 28 all-cause mortality rate

The proportion of subjects with clinical success at Day 4

The proportion of subjects with clinical success at EOT

+5 more

Other study objectives

Number of days in intensive care unit (ICU)

Number of days on a ventilator and ventilator free days

Total number of days in hospital

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Imipenem/Cilastatin/XNW4107Experimental Treatment1 Intervention

Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg, Q6h (0.5h Infusion)

Group II: Imipenem/Cilastatin/RelebactamActive Control1 Intervention

Imipenem/Cilastatin/Relebactam 1.25g Q6h (0.5h Infusion)

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bacterial pneumonia, such as the combination of imipenem, cilastatin, and potentially a beta-lactamase inhibitor like XNW4107, work by targeting bacterial cell wall synthesis and protecting the antibiotic from degradation. Imipenem inhibits cell wall synthesis, leading to bacterial death, while cilastatin prevents its breakdown in the kidneys, enhancing its efficacy. A beta-lactamase inhibitor would further protect imipenem from bacterial enzymes that confer resistance. This multi-faceted approach is essential for effectively treating bacterial pneumonia, especially in the presence of resistant bacterial strains.

[Clinical evaluation of imipenem/cilastatin sodium in the internal medicine].Successful management of multidrug-resistant Pseudomonas aeruginosa pneumonia after kidney transplantation in a dog.