A Phase 2 interventional study of TQD3524 and Meropenem for injection in Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 27 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (part of Sino Biopharmaceutical Limited) · Phase 2, Interventional, and Treatment
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria.
153 studies on the registry are indexed under Pneumonia, Bacterial; 27 are open to participants now.
This study's planned enrollment of 48 is below the median of 132 across 107 interventional studies indexed under Pneumonia, Bacterial.
Browse Pneumonia, Bacterial studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 320 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TQD3524: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days
Drug: TQD3524 · Drug: Meropenem for injection
Colistimethate Sodium for Injection: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days
Drug: Meropenem for injection · Drug: Colistimethate Sodium for Injection
TQD3524: 3.75mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days
Drug: TQD3524 · Drug: Meropenem for injection
Colistimethate Sodium for Injection: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days
Drug: Meropenem for injection · Drug: Colistimethate Sodium for Injection
After entering the body, TQD3524 can be hydrolyzed into polymyxin E2 and its derivatives, exerting bactericidal effects .
Meropenem for injection is a β-lactam.
Colistimethate Sodium for Injection is a prodrug of polymyxin E. After entering the body, polymyxin E mesylate is hydrolyzed to polymyxin E (colistin), which exerts bactericidal activity.
The proportion of subjects who achieved clinical cure
The proportion of subjects who achieved clinical cure in the modified intention-to-treat (mITT) population at the treatment-end visit (TOC) based on clinical efficacy evaluation.
Time frame: Up to 28 days
The percentage difference in subjects achieving clinical cure between the experimental group and the control group
During the TOC visit, the percentage difference in subjects achieving clinical cure between the modified intention-to-treat (mITT) populations of the test group and the control group.
Time frame: Up to 28 days
The bacterial clearance rate
The bacterial clearance rate at the Time of Clinical Outcome (TOC) visit and the End of Treatment (EOT) visit in the microbiologically Improved Intent-to-Treat (micro-mITT) population and the Microbiologically Evaluable (ME) population.
Time frame: Up to 28 days
The proportion of subjects who achieved clinical cure
The proportion of subjects in the mITT population who achieved clinical cure in the clinical efficacy evaluation at the EOT visit.
Time frame: Up to 21 days
The proportion of subjects who achieved clinical cure
The proportion of subjects in the clinically evaluable (CE) population who achieved clinical cure in the clinical efficacy assessment at the EOT visit.
Time frame: Up to 21 days
The proportion of subjects who achieved clinical cure
The proportion of subjects in the CE population who achieve clinical cure in the clinical efficacy evaluation during the TOC visit
Time frame: Up to 28 days
All-cause mortality
All-cause mortality rate in the mITT population on Day 28 ± 2 after the first dose.
Time frame: Up to 28 days
Average duration of mechanical ventilation
The average duration of mechanical ventilation in the mITT population.
Time frame: Up to 28 days
Average length of hospital stay
The average length of hospital stay from the first dose to the end of the follow-up period in the mITT population.
Time frame: Up to 28 days
Change in APACHE II score
Changes in APACHE II scores before and after treatment in the mITT population. The higher the score, the more severe the condition.
Time frame: Up to 28 days
Change value of procalcitonin
Change in procalcitonin levels from baseline during TOC visits in the mITT population.
Time frame: Up to 28 days
The proportion of patients experiencing adverse reactions
The proportion of patients experiencing adverse reactions.
Time frame: Up to 28 days
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