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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
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)
Fulfills clinical criteria with symptoms or signs of cough, expectorated sputum production, dyspnea, worsening oxygenation, increase in respiratory secretions, fever/ hypothermia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at late follow-up (lfu), up to 31 days
Awards & highlights

REITAB-2 Trial Summary

This trialwill compare two drugs to treat hospital- or ventilator-acquired pneumonia in adults.

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.Check my eligibility
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.See study design
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.

REITAB-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a lung infection needing IV antibiotics, starting after hospital stay or ventilation.
Select...
I have symptoms like coughing, difficulty breathing, or fever.
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I am willing to use birth control during and after the study.

REITAB-2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Day 14 all-cause mortality rate
Secondary outcome measures
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 outcome measures
Number of days in intensive care unit (ICU)
Number of days on a ventilator and ventilator free days
Total number of days in hospital

REITAB-2 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)

Find a Location

Who is running the clinical trial?

Sinovent Pty Ltd.Lead Sponsor
7 Previous Clinical Trials
1,037 Total Patients Enrolled
Evopoint Biosciences Inc.Lead Sponsor
8 Previous Clinical Trials
1,241 Total Patients Enrolled
Jason LeStudy ChairEvopoint Biosciences USA, Inc.)
4 Previous Clinical Trials
952 Total Patients Enrolled

Media Library

Cilastatin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05204563 — Phase 3
Bacterial Pneumonia Research Study Groups: Imipenem/Cilastatin/Relebactam, Imipenem/Cilastatin/XNW4107
Bacterial Pneumonia Clinical Trial 2023: Cilastatin Highlights & Side Effects. Trial Name: NCT05204563 — Phase 3
Cilastatin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204563 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are partaking in this clinical experiment?

"This medical trial requires 450 eligible individuals to enroll, and multiple sites have opened for enrollment such as Jackson Memorial Hospital (JMH) - Ryder Trauma Center in Miami, Florida and USF-TGH in Tampa, Maryland."

Answered by AI

Has the Imipenem/Cilastatin/XNW4107 combination been given regulatory clearance by the FDA?

"Our analysts at Power assign a safety score of 3 to Imipenem/Cilastatin/XNW4107 due to the Phase 3 trial process, wherein there exists evidence for efficacy and multiple instances of data corroborating its security."

Answered by AI

How widely is this experiment being implemented?

"The current roster of clinical sites active in this trial includes Jackson Memorial Hospital (JMH) - Ryder Trauma Center in Miami, USF-TGH in Tampa, and University of Maryland Medical Center in Baltimore; 6 other locations are also participating."

Answered by AI

Does this research endeavor currently seek participants?

"Affirmative. The clinicaltrials.gov database states that this medical trial, originally launched on July 31st 2022, is currently recruiting for participants. It seeks 450 individuals to be enrolled across 9 different sites."

Answered by AI
~169 spots leftby Apr 2025