Can a new antibiotic outmatch an old one against Drug-Resistant pneumonia?
NCT ID NCT07759934
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial is testing an experimental antibiotic called ASK0912 against an older drug, polymyxin B, in adults with hospital-acquired or ventilator-associated pneumonia caused by multidrug-resistant bacteria. Participants will receive one of two dosing schedules of ASK0912 or the standard polymyxin B treatment for 7 to 14 days. The study will compare how well each treatment clears the infection and whether it reduces deaths within 28 days, while also monitoring safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ASK0912 for injection
- What this could lead to
- If successful, this could provide a new treatment option for serious hospital-acquired pneumonia caused by drug-resistant bacteria, potentially with a better safety profile than current antibiotics.
- What could go wrong
- This is an early-phase trial with a small number of patients, so results may not hold up in larger studies. The drug may not be more effective or safer than the existing treatment, and side effects are still being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 pneumonia caused by Mycoplasma, Chlamydia, Legionella, fungi, parasites, viruses, or chemical etiologies (including gastric aspiration, inhalation injury).Additionally, subjects with confirmed or suspected community-acquired bacterial pneumonia (CABP) are excluded. * 5\. Presence of underlying pulmonary conditions that may interfere with efficacy assessment, such as pulmonary tuberculosis, lung abscess, empyema, obstructive pneumonia, granulomatous disease, recent pulmonary embolism, moderate-to-severe bronchiectasis, severe chronic obstructive pulmonary disease, bronchial obstruction, idiopathic interstitial pneumonia, etc. * 6\. Presence of other active infections that may interfere with efficacy assessment, or bacterial infectious foci requiring concomitant treatment with antibacterial agents prohibited by the study protocol, such as invasive fungal infection, endocarditis, central nervous system infection (e.g., meningitis, brain abscess, post-shunt infection), septic arthritis requiring vancomycin, etc. * 7\. Severe cardiac disorders, including severe arrhythmia, significant myocardial ischemia, congestive heart failure classified as NYHA Class III-IV. * 8\. Subjects with liver cirrhosis classified as Child-Pugh Class C. * 9\. Subjects with documented immunodeficiency or impaired immune function, including HIV infection, hematological malignancies, bone marrow transplantation, etc.; or subjects receiving immunosuppressive therapy, including immunosuppressants, chemotherapeutic agents, drugs for prevention of transplant rejection, and corticosteroids (prednisone ≥ 20 mg/day for more than 14 days). * 10\. Presence of any one of the following abnormalities: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 5 × upper limit of normal (ULN); AST and/or ALT \> 3 × ULN accompanied by total bilirubin \> 1.5 × ULN; creatinine clearance \< 80 mL/min (calculated using the Cockcroft-Gault formula); absolute neutrophil count \< 1 × 10⁹/L; platelet count \< 60 × 10⁹/L. * 11\. Subjects with a history or evidence of severe renal disease, or receiving hemodialysis or peritoneal dialysis. * 12\. Subjects presenting with shock. * 13\. Subjects scheduled to undergo major surgery during the study period. * 14\. Subjects with a known history of epilepsy or neuromuscular junction disorders such as myasthenia gravis. * 15\. Subjects with any past or current disease, treatment, laboratory abnormality, or other condition that, in the investigator's opinion, may compromise the quality of study data or increase treatment risks during the study, e.g., subjects requiring valproic acid therapy during the study. * 16\. Subjects with any psychiatric or psychological disorder judged by the investigator to potentially increase trial risks, impair protocol compliance, or hinder study completion, such as recent (within the past 12 months) or active suicidal ideation/behavior. * 17\. Subjects judged by the investigator on clinical assessment to be at risk of death within the 7-14-day treatment phase despite adequate antibiotic therapy for pneumonia. * 18\. Female subjects who are breastfeeding or plan to breastfeed prior to the end of the study. * 19\. Any other conditions rendering the subject unsuitable for participation in this study as determined by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hospital-acquired bacterial pneumonia (HABP) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Jiangsu AOSAIKANG Pharm
RECRUITINGNanjing, Jiangsu, 210000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.