New hope against superbug pneumonia: Dual-Action antibiotic trial launches

NCT ID NCT07512596

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether a new antibiotic called polymyxin E2, given both through a vein and as a mist inhaled into the lungs, can safely cure hospital-acquired pneumonia caused by drug-resistant bacteria. About 48 adults with this serious lung infection will receive either the new treatment or a standard antibiotic. The goal is to see if the combination clears the infection better and helps patients recover.

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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 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years old (based on the date of signing the informed consent form); * The subject (or their guardian) voluntarily signed the informed consent form； * Acute pulmonary infection with hospitalization duration exceeding 48 hours or within 7 days after discharge; or acute pulmonary infection patients who have undergone mechanical ventilation via oral or nasal tracheal intubation for at least 48 hours; * Chest imaging examination (X-ray or CT) within 72 hours prior to randomization reveals characteristics of new or worsening pulmonary infiltration; * At least one of the following physical signs or laboratory abnormalities: ① fever (temperature ≥38℃); ② hypothermia (temperature ≤35℃); ③ elevated peripheral white blood cell count (WBC ≥10×10\^9/L); ④ decreased white blood cell count (WBC ≤4.5×10\^9/L); ⑤ more than 15% of immature neutrophils such as band forms in peripheral blood; * At least one of the following clinical symptoms is present: ① new or acute worsening of pulmonary symptoms or signs, such as cough, dyspnea, increased respiratory rate (respiratory rate \> 25 breaths per minute), expectoration, or the need for mechanical ventilation; ② hypoxemia (arterial blood gas oxygen partial pressure below 60 mmHg at standard atmospheric pressure, or a progressive decrease in the ratio of oxygen partial pressure to inspired oxygen concentration (PaO2/FiO2)); ③ deteriorating oxygenation requiring replacement of ventilation support system to improve oxygenation, or a change in the level of positive end-expiratory pressure support; ④ new respiratory secretions requiring suction; * A specific carbapenem-resistant Gram-negative bacterium was cultured from qualified lower respiratory tract specimens within the first five days/screening period, with in vitro susceptibility testing confirming resistance to carbapenems； * Female subjects without reproductive potential must meet at least one of the following criteria: a) cessation of regular menstruation for at least 12 consecutive months; b) having undergone hysterectomy and/or bilateral oophorectomy. Female subjects with reproductive potential must have a negative serum pregnancy test result at the screening visit and agree to use reliable contraception throughout the study period; * Male subjects must agree to adopt reliable contraceptive measures throughout the entire study period. Exclusion Criteria: * Those who currently suffer from epilepsy/myasthenia gravis or have a history of seizures (excluding febrile seizures in childhood)/myasthenia gravis; * Those who are undergoing hemodialysis or peritoneal dialysis; * Combined infections with other lung microbiota: viral pneumonia, fungal pneumonia, pulmonary tuberculosis, atypical pathogen infections, etc； * Current concurrent infection of other parts/organs; * Patients with concurrent refractory septic shock, who still exhibit persistent hypotension despite adequate fluid resuscitation or vasopressor therapy prior to randomization; * Individuals with immune deficiency or compromised immune function, including but not limited to: human immunodeficiency virus infection, hematological malignancies, bone marrow transplantation, immunosuppressive therapy, and systemic corticosteroid treatment (defined as a daily dose equivalent to prednisone ≥20mg and a treatment duration \>14 days); * During the screening period, any of the following laboratory abnormalities is present: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels are more than 5 times the upper limit of normal, or AST and/or ALT levels are more than 3 times the upper limit of normal and total bilirubin levels are more than 1.5 times the upper limit of normal, or neutrophil count \< 1.0×10\^9/L, or platelet count \< 60×10\^9/L; creatinine clearance rate (cLcr) ≤ 50 mL/min; * Suffering from lung diseases that can interfere with treatment response assessment; * Patients with lung abscess, empyema, and mechanical obstructive pneumonia; * New York Heart Association (NYHA) class III-IV heart failure; * Transplant patients； * Patients with an estimated survival time of less than 1 month according to the clinical judgment of the researchers; * Individuals with allergic reactions to polymyxins or carbapenems; * Sbjects requiring \>2 systemic antimicrobial drugs for the treatment of Gram-negative bacterial infections; * Patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 30; * Women who are pregnant or breastfeeding; * Use potentially effective antibiotics to treat carbapenem resistant gram-negative bacterial infections within 72 hours prior to randomization, and the treatment duration exceeds 24 hours； * When the culture results of samples from the first 5 days/screening period are available, it is found that the subject has Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia (HAP/VAP) caused by gram-negative bacteria that are expected to have no response to polymyxin drugs; * Subjects who have participated in other clinical trials within 30 days prior to the first dose of medication; * Other factors determined by the researcher that make the subject unsuitable for participating in this study.

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Conditions

The condition(s) this trial relates to.

nosocomial infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

27 sites. 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.

Open the record ↗
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

Beijing Tsinghua Changgung Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 102200, China
Chengdu Third People's Hospital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610031, China
First Affiliated Hospital of Gannan Medical University
NOT_YET_RECRUITING

Ganzhou, Jiangxi, 341000, China
Foshan Nanhai District People's Hospital
NOT_YET_RECRUITING

Foshan, Guangdong, 528200, China
Henan Provincial People's Hospital
NOT_YET_RECRUITING

Zhengzhou, Henan, 450003, China
Northern Jiangsu People's Hospital
NOT_YET_RECRUITING

Yangzhou, Jiangsu, 225000, China
Nuclear Industry 416 Hospital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610051, China
Peking University Shenzhen Hospital
NOT_YET_RECRUITING

Shenzhen, Guangdong, 518036, China
People's Hospital of Hunan Province
NOT_YET_RECRUITING

Changsha, Hunan, 410005, China
Shanghai General Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200080, China
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200433, China
Sichuan Provincial People's Hospital
RECRUITING

Chengdu, Sichuan, 610072, China
The Fifth Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING

Zhengzhou, Henan, 450052, China
The Fifth Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING

Zhuhai, Guangdong, 519000, China
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING

Bengbu, Anhui, 233000, China
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710000, China
The First Clinical College of Guangzhou Medical University
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510120, China
The Second Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING

Zhengzhou, Henan, 450052, China
The Second Hospital Of Hebei Medical University
NOT_YET_RECRUITING

Shijiazhuang, Hebei, 050000, China
The Third Hospital of Changsha
NOT_YET_RECRUITING

Changsha, Hunan, 410015, China
Tianjin First Central Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300191, China
Tianjin Medical University General Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300052, China
Xi'an Chest Hospital
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710100, China
Xiangya Hospital of Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410000, China
Yan'an University Xianyang Hospital
NOT_YET_RECRUITING

Xianyang, Shaanxi, 712000, China
Zhengzhou Central Hospital
NOT_YET_RECRUITING

Zhengzhou, Henan, 450007, China

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