BridgeMD
Tests treatment safety and results for Hospital-acquired Bacterial Pneumonia and...
Official title A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
ClinicalTrials.gov ID: NCT07327619
What this study is testing
What is Meropenem and Pralurbactam?
Meropenem and Pralurbactam is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and Avibactam Sodium for Injection.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 1\. Male or female participants ≥18 and ≤80 years of age
- 2\. have a diagnosis of HAP/VAP.
- 3\. have systemic signs and respiratory signs or symptoms of HAP/VAP.
- 4\. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.
- 5\. The estimated survival time is at lest 28 days.
You likely can't join if
- 1\. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.
- 2\. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.
- 3\. Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30.
- 4\. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase...
- 5\. Those who have a history of drug abuse or drug abuse within 6 months before screening.
- 6\. Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.
The study team makes the final eligibility decision.
Where it's taking place
- Huaihua, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huaihua, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.