ASK0912 Versus Polymyxin B for Injection in Adults With Hospital-Acquired or Ventilator-Associate… (NCT07759934) | Clinical Trial Compass
RecruitingPhase 2
ASK0912 Versus Polymyxin B for Injection in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
China60 participantsStarted 2026-03-25
Plain-language summary
This is a randomized, active-controlled, multicenter phase II clinical trial. The study aims to evaluate the efficacy, safety and tolerability of two different dosing regimens of ASK0912 for Injection compared with Polymyxin B Sulfate for Injection in adult patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by multidrug-resistant or carbapenem-resistant Gram-negative bacilli. Eligible subjects will be randomly assigned to one of three treatment groups: ASK0912 Regimen 1, ASK0912 Regimen 2, or Polymyxin B Sulfate active comparator group. Subjects will receive assigned intravenous study treatment for 7 to 14 days. The primary efficacy endpoints include clinical cure rate at the Test of Cure (TOC) visit and Day 28 all-cause mortality in the modified intent-to-treat (MITT) population. Safety assessments will be conducted throughout the study to monitor adverse events, laboratory parameters and other safety indicators.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Aged 18-75 years on the day of informed consent signature;
* 2\. Require intravenous antibiotic therapy for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
* 3\. At least one clinical sign or symptom of HABP/VABP.
* 4\. At least one laboratory abnormality of HABP/VABP.
* 5\. Chest imaging at screening demonstrating new or progressive infiltrates consistent with pneumonia.
* 6\. APACHE II score ≤ 30.
* 7\. Appropriate lower respiratory tract specimen obtained at screening for Gram stain and bacterial culture.
* 8\. Subjects receiving HABP/VABP-active antibiotics within 72h pre-enrollment may enroll if ≤24h therapy, or ≥48h with persistent/worsening HABP/VABP signs/symptoms at screening.
* 9\. Women of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment.
* 10\. Male subjects must use highly effective contraception throughout the study period.
Exclusion Criteria:
* 1\. Subjects with known allergy to polymyxins or carbapenems, regardless of the severity of the reaction; or subjects with a severe hypersensitivity reaction to any other β-lactam agent.
* 2\. Subjects who have received any investigational product within 3 months prior to enrollment, or subjects who have previously participated in this clinical study.
* 3\. Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only.
* 4\. Known or suspected pneumoni…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Achieving Clinical Cure at Test of Cure (TOC) Visit in the Modified Intent to Treat (MITT) Population
Timeframe: Up to approximately 28 days
2
Percentage of Participants With All-cause Mortality(ACM) Through Day 28 in the Modified Intent to Treat (MITT) Population