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Mental Health IssuePhase 3NCT06198764

A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With Colistimethate Sodium for Injection

A Phase 3 study testing Colistimethate sodium for injection, Meropenem for Injection and Coly Mycin M Injectable Product in people with Mental Health Issue, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 32 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A clinical study to evaluate Colistimethate Sodium for Injection combination with Meropenem versus Coly-Mycin® M Parenteral combined with Meropenem in the treatment of Carbapenem resistant gram-negative bacteria infection. A total of 80 patients will be enrolled in the study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mental Health Issue
What is being tested?
Colistimethate sodium for injection, Meropenem for Injection and Coly Mycin M Injectable Product
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
32 sitesChina
Study dates
6 Jul 2023to Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old (based on the signing time of the informed consent form).
  • The subject (or their guardian) voluntarily signs an informed consent form.
  • Clinical diagnosis confirmed carbapenem resistant Gram negative bacterial infections, including hospital-acquired bacterial pneumonia (HAP) / ventilator-associated bacterial pneumonia (VAP), complicated urinary tract infection (cUTI) , complicated intra-abdominal infection (cIAI), and bloodstream infection (BSI) subjects (minimum disease criteria refer to each additional inclusion criteria)
  • Cultivate a Gram negative bacterium identified as carbapenem resistant within 5 days before or during the screening period (mainly including carbapenem resistant Enterobacteriaceae, carbapenem resistant Acinetobacter baumannii, and carbapenem resistant Pseudomonas aeruginosa), and the Gram negative bacteria showed drug resistance to carbapenems in vitro drug sensitive test. In this study, gram-negative bacteria resistant to carbapenems also included strains with bacterial drug sensitivity displayed as "intermediate", that is, resistant bacteria include strains that are intermediate and resistant to carbapenem antibiotics.
  • Within 72 hours before randomization, for those who have previously received empirical antimicrobial treatment, the duration of antimicrobial treatment (excluding polymyxin antibiotics) does not exceed 24 hours or the treatment exceed 48 hours but the infection symptoms/signs still exist or become worsen.
  • HAP/VAP subjects are required to meet:
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  • Patients with acute pulmonary parenchymal infection who have been hospitalized for more than 48 hours or discharged for less than 7 days, or have received mechanical ventilation through oral or nasal tracheal intubation for at least 48 hours;
  • Chest X-ray examination (or computed tomography) obtained within 72 hours before randomization shows new infiltrating lesions or progression of existing lesions;
  • Individuals with at least 2 of the following clinical symptoms/signs:
  • New occurrence cough；
  • Produce purulent sputum or tracheal secretions；
  • The auscultation results are accord with pneumonia/lung consolidation (such as wet rale, dry rale, bronchial breath sound, egophony, dull percussion note);
  • Difficulty in breathing, shortness of breath (respiratory rate>25 breaths/minute), or hypoxemia (oxygen saturation< 90% when breathing indoor air at standard atmospheric pressure or arterial blood oxygen partial pressure (PaO2) obtained through arterial blood gas (ABG)<60 mmHg);
  • The oxygenation index (arterial partial pressure of oxygen/percentage of inhaled oxygen concentration (PaO2/FiO2)) deteriorates, requiring urgent changes in ventilator support status or changes in positive end expiratory pressure ventilation volume.
  • Within 72 hours before the first dose of study drug, the subject is required to take appropriate respiratory specimens (such as sputum, respiratory secretions, culture samples, etc.)
  • With at least one of the following evidence of systemic inflammatory reactions:
  • Recorded fever (oral temperature ≥ 38 ℃ or axillary temperature ≥ 37.5 ℃) or hypothermia (rectal/core temperature ≤ 35 °C);
  • Peripheral blood leukocyte count ≥ 10000/mm ^3 or peripheral blood leukocyte count ≤ 4500/mm ^3 or peripheral blood rod-shaped granulocytes >15%.
  • CUTI subjects with/without pyelonephritis are required to meet:
  • Urinary routine examination shows pyuria, i.e. non centrifuge urine examination ≥ 10 WBC/µ l, centrifuge urine examination white blood cell count (WBC) >5/HPF, or urine routine WBC higher than the upper limit of normal values of each participating unit;
  • Individuals with at least 2 of the following clinical symptoms or signs:
  • Fever with or without chills or chills. Acute pyelonephritis must have signs of fever.
  • Lateral abdominal pain or pelvic pain;
  • Nausea or vomiting;
  • Difficulty of urinating, frequent urination, urgency or pain in urination;
  • There is tenderness or percussion pain in the costovertebral angle during physical examination.
  • The subject must have at least one of the following basic diseases or conditions with abnormal urinary tract structure or function(excluding acute pyelonephritis):
  • Urinary tract obstruction (renal stones, renal fibrosis);
  • Functional/anatomical abnormalities of the genitourinary tract (including anatomical abnormalities or neurogenic bladder) or residual urine volume after urination ≥ 100 mL;
  • Urinary retention, including those caused by benign prostatic hypertrophy;
  • Patients with renal diseases such as glomerulonephritis and nephrotic syndrome;
  • It is known that patients meet the requirements of 30 mg/g<urinary microalbumin/creatinine ratio ≤ 300 mg/g with diabetes nephropathy.
  • Within 72 hours before the first dose of study drug, subjects are required to take clean mid section urine, with a bacterial colony count in urine culture greater than 105 CFU/mL.
  • CIAI subjects are required to meet:
  • Subjects must arrange or have completed open surgery, laparoscopic surgery, or percutaneous drainage of abdominal abscesses for the diagnosis and treatment of cIAI within 24 hours of enrollment or within 24 hours of administering the first dose of antibiotics;
  • For subjects enrolled before surgery, study medication can only be administered when there is a high suspicion or diagnosis of intra-abdominal infection, and baseline intra-abdominal culture specimens from the infected site are planned to be obtained;
  • Appearance of one or more systemic symptoms or signs of cIAI, such as fever, hypotension, abdominal pain, nausea and vomiting, abdominal lumps found during physical examination, and changes in mental state.
  • With at least one of the following evidence of systemic inflammatory response:
  • Recorded fever (oral temperature ≥ 38 ℃ or axillary temperature ≥ 37.5 ℃) or hypothermia (rectal/core temperature ≤ 35 °C);
  • Peripheral blood leukocyte count ≥ 10000 /mm^3 or peripheral blood leukocyte count ≤ 4500 /mm^3 or peripheral blood rod-shaped granulocytes >15%.
  • BSI subjects are required to meet:
  • At least one of blood culture tests conducted was positive within 5 days prior to screening, indicating the presence of Gram negative bacteria. This research can include participants with multiple microbial(Including carbapenem resistant Gram negative bacteria) infections. (Note: This study plans to include patients with primary BSI, defined as pathogenic microorganisms with positive blood culture that are not associated with other infection sites.)
  • With at least one of the following evidence of systemic inflammatory response:
  • Recorded fever (oral temperature ≥ 38 ℃ or axillary temperature ≥ 37.5 ℃) or hypothermia (rectal/core temperature ≤ 35 °C)；
  • Peripheral blood leukocyte count ≥ 10000 /mm^3 or peripheral blood leukocyte count ≤ 4500 /mm^3 or peripheral blood rod-shaped granulocytes >15%.

Who cannot join

  • Individuals who currently have epilepsy/myasthenia gravis or have a history of seizures (excluding febrile seizures in childhood)/myasthenia gravis history.
  • Individuals undergoing hemodialysis or peritoneal dialysis.
  • Invasive aspergillosis, mucormycosis, or other invasive fungal diseases.
  • Current patients complicated with other infections, including endocarditis, osteomyelitis, central nervous system infection (such as meningitis, brain abscess, infection after cerebrospinal fluid shunt or shunt device infection), artificial joint infection, and active tuberculosis.
  • It is currently complicated with refractory septic shock, and there was still persistent hypotension after sufficient fluid resuscitation or pressure therapy before randomization.
  • Evidence of obvious liver disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy.
Show all 31Show fewer
  • Individuals with immunodeficiency or low immune function, including but not limited to: human immunodeficiency virus infection, hematological malignancies, bone marrow transplantation, immunosuppressive therapy, systemic corticosteroid therapy (defined as a daily dose equivalent to prednisone ≥ 20 mg and a course of treatment>14 days).
  • Individuals with any laboratory test abnormalities during the screening period: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) are 5 times higher than the upper limit of normal, or AST and/or ALT are 3 times higher than the upper limit of normal and total bilirubin is 1.5 times higher than the upper limit of normal, or neutrophil count is less than 1.0× 10^9/L or platelet count<60 ×10^9/L; Creatinine clearance rate ≤ 50 ml/min.
  • According to the clinical judgment of the researchers, the expected survival period is less than 1 month.
  • Individuals with allergic reactions to polymyxin or carbapenems.
  • Subjects who require more than 2 systemic antibiotics for the treatment of Gram negative bacterial infections.
  • Patients with acute physiology and chronic health (APACHE II) scores greater than 30.
  • HAP/VAP subjects need to exclude:
  • Patients with lung diseases that can interfere with treatment response evaluation, (such as cystic fibrosis, granulomatous diseases, pulmonary fungal infections, or recent pulmonary embolism);
  • Individuals with lung abscess, empyema, or obstructive pneumonia;
  • New York Heart Association (NYHA) Grade III-IV heart failure
  • Lung or heart transplant recipients.
  • CUTI subjects with/without pyelonephritis need to excluded:
  • Subjects suspected or confirmed to have prostatitis;
  • Renal transplant recipients;
  • Individuals with ileal loops;
  • Individuals who may continue to receive prophylactic treatment with antibiotics during clinical trials, such as those with bladder ureteral reflux;
  • Patients that the indwelling catheter cannot be replaced during the study;
  • Any unrecovered pelvic or urinary tract trauma;
  • Individuals with simple urinary tract infections.
  • cIAI subjects need to exclude:
  • Upper gastrointestinal perforation, unless there is clear evidence of secondary infection in the abdominal cavity;
  • Enrolled after surgery, but received over 1 dose of potentially effective systemic antibacterial medication before surgery.
  • BSI subjects need to exclude:
  • Subjects who only obtain positive blood culture through venous catheters (if both peripheral venous puncture blood culture and venous catheter blood culture show the same microbiological results, subjects can be selected);
  • Infection is caused by intravascular sources, such as endocarditis, infected vascular grafts, and permanent intravascular devices that cannot be removed during treatment.

Trial locations and contacts

32 sites in 1 country.

Yingyuan Zhang, Bachelor of Medicine contact

13917467481

yyzhang39@hotmail.com

Haihui Huang, Doctor contact

13916685836

Huanghaihui@fudan.edu.cn

32 sites in 1 country

China32 sites, 31 recruiting

  • Beijing You'an Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100069

    Yulin Zhang, 18600958901, yulinzhang@ccmu.edu.cn

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099

    Shibing Zhao, Doctor, 13855212871, zhaoshibing523@163.com

    Recruiting

  • The Second Norman Bethune Hospital of Jilin University

    Changchun, Jilin, 130041

    Jie Zhang, Doctor, 13504326312, doctorzhangj@163.com

    Recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130061

    Liping Peng, 13756661263, plp640317@163.com

    Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410002

    Jianmin Li, 13787087700

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

    Yuanyuan Li, doctor, Leeround@163.com

    Recruiting

  • Changsha Central Hospital

    Changsha, Hunan, 410028

    Hongzhong Yang, Doctor, 13707312398, hzhy82@sina.com

    Recruiting

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046099

    Xianping Zhao, 13453503966, z13453503966@163.com

    Yadong Cheng, 13593282841, 13593282841@139.com

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610044

    Yanbin Liu, Doctor, 18980601983, dr_liuyanbin@foxmail.com

    Recruiting

  • The People's Hospital of Chizhou

    Chizhou, Anhui, 247099

    Xuehong Jiang, Master, 15339668667, jxhabc@sohu.com

    Recruiting

  • People's Hospital of Chongqing Banan District

    Chongqing, Chongqing Municipality, 401320

    Wei Sun, 1898345252, 285446833@qq.com

    Recruiting

  • Chongqing University Jiangjin Hospital

    Chongqing, Chongqing Municipality, 402260

    Jun Yang, 15923575625, 30840575@qq.com

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510260

    Zhanguo Liu, Doctor, 18520711669, zhguoliu@163.com

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Qingwei Zhao, 13588066886, zyct79@163.com

    Hongliu Cai, 13505811696, caiicu@163.com

    Recruiting

  • Huai'an Second People's Hospital

    Huaian, Jiangsu, 223022

    Yufeng Wan, 15805230282, wyflcx@sina.com

    Recruiting

  • Luoyang Central Hospital

    Luoyang, Henan, 471099

    Lihong Han, Master, 13938817645, Hlh120@sina.com

    Recruiting

  • General Hospital of the Eastern Theater Command

    Nanjing, Jiangsu, 210002

    Yong Song, Doctor, 13851761392, song_yong6310@126.com

    Recruiting

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472099

    Jinying Tian, Bachelor, 15036498592, caixiaohan98@126.com

    Recruiting

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200000

    Yingyuan Zhang, Bachelor of Medicine, 13917467481, yyzhang39@hotmail.com

    Recruiting

  • Huadong Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

    Huili Zhu, 13701802382, zhuhuili001@126.com

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Jinfu Xu, Doctor, 13321922898, jfxucn@163.com

    Recruiting

  • Shanghai Jiading District Central Hospital

    Shanghai, Shanghai Municipality, 201899

    Liou Cao, Doctor, 13764667784, wwclo@126.com

    Recruiting

  • The First Affiliated Hospital of Shantou University School of Medicine

    Shantou, Guangdong, 515041

    Yongru Chen, Master, 13411969797, yongruchen@126.com

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

    Xiaochun Ma, Doctor, 13840192939, Mxc2972@163.com

    Recruiting

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110031

    Zhuang Ma, Doctor, 13309889964, ma-tianyi@163.com

    Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Xiaodong Liu, Master, 13333518307, lxdhami@126.com

    Recruiting

  • Taizhou Hospital of TCM

    Taizhou, Jiangsu, 225399

    Guohua He, 13337789628, 2572217420@qq.com

    Yuanhua Ding, 18961000589, tzdd2002@163.com

    Recruiting

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300222

    Active, not recruiting

  • The First Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region, 830054

    Xiangyou Yu, Master, 13009681003, yu2796@163.com

    Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

    Huiqing Zeng, Master, 13606080893, 13606080893@139.com

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

    Xiansheng Zeng, Doctor, 15172603728, 310355055@qq.com

    Recruiting

  • Jiangsu Subei People's Hospital

    Yangzhou, Jiangsu, 225003

    Xingxiang Xu, Doctor, 18051062315, Xuxx63@sina.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open, Parallel Controlled Clinical Study to Evaluate the Efficacy and Safety of Colistimethate Sodium for Injection in the Treatment of Carbapenem Resistant Gram-negative Infections in Chinese Adults.

A clinical study to evaluate Colistimethate Sodium for Injection combination with Meropenem versus Coly-Mycin® M Parenteral combined with Meropenem in the treatment of Carbapenem resistant gram-negative bacteria infection. A total of 80 patients will be enrolled in the study.

Being tested
Colistimethate sodium for injection, Meropenem for Injection, Coly Mycin M Injectable Product

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colistimethate sodium for injectionDrug

    Colistimethate Sodium for Injection is the Prodrug of Polymyxin E, which is hydrolyzed into Polymyxin E after entering the human body to play a bactericidal role.Polymyxin selectively acts on gram-negative aerobic bacteria with hydrophobic outer membrane, leading to cell death by destroying the cell membrane.

  • Meropenem for InjectionDrug

    Meropenem is a broad-spectrum carbapenem antibiotic that inhibits the synthesis of bacterial cell walls by penetrating the cell wall and reaching its target, the penicillin-binding protein, to ultimately produce antibacterial effects.

  • Coly Mycin M Injectable ProductDrug

    Coly Mycin M is the originally marketed colistimethate sodium for injection.

Study groups in NCT06198764
Study groupRoleWhat they receive
Colistimethate sodium for Injection + MeropenemExperimentalIntravenous infusion of colistimethate sodium for injection for 7-14 days. Meropenem intravenous infusion once every 8 hours or 12 hours.
Receives: Drug: Colistimethate sodium for injection; Drug: Meropenem for Injection
Coly-Mycin® M Parenteral + MeropenemActive comparatorIntravenous infusion of Coly-Mycin® M Parenteral for 7-14 days. Meropenem intravenous infusion once every 8 hours or 12 hours.
Receives: Drug: Meropenem for Injection; Drug: Coly Mycin M Injectable Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical cure rate (mITT)

    The proportion of patients in the modified intention to treat (mITT) population who achieved clinical cure at test of cure (TOC).

    Measured: At TOC visit, which is 7-14 days after the end of treatment.

Secondary outcomes (6)

  1. Bacterial clearance rate

    Bacterial clearance rate of micro-MITT population at TOC visit

    Measured: At TOC visit, which is 7-14 days after the end of treatment.

  2. Clinical cure rate

    The proportion of subjects with clinical evaluation of clinical cure at the TOC visit. Clinical cure refers to the following: The symptoms, signs, and laboratory test abnormalities of the subjects who were infected after the end of treatment have all returned to normal or pre-infection status, and no new symptoms, signs, or laboratory test abnormalities have occurred, nor have complications occurred.

    Measured: At TOC visit, which is 7-14 days after the end of treatment.

  3. Microbiological efficacy

    The proportion of subjects with effective microbial efficacy evaluation (microbial clearance or presumed clearance, including bacterial population alternation, which is also classified as clearance) according to subject evaluation and pathogen evaluation during the TOC visit.

    Measured: At TOC visit, which is 7-14 days after the end of treatment.

  4. All-cause mortality rate

    The all-cause mortality rate at 28±2 days in the mITT population

    Measured: 28±2 days after randomization.

  5. Peak concentration (Cmax)

    Maximum plasma drug concentration

    Measured: 72 hours before the first dose; 30 minutes before the first dose, at the end and 2, 4, 6, 8 hours after dose on day 4; 30 minutes before the second dose; 30 minutes before the first dose on day 10.

  6. Peak time (Tmax)

    Time to reach maximum plasma drug concentration

    Measured: 72 hours before the first dose; 30 minutes before the first dose, at the end and 2, 4, 6, 8 hours after dose on day 4; 30 minutes before the second dose; 30 minutes before the first dose on day 10.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start6 Jul 2023
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06198764
Sponsor's protocol ID
TQD3519-CS-01
Status last verified
Dec 2023
First submitted
27 Dec 2023
Last updated
10 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colistimethate sodium for injection, Meropenem for Injection and Coly Mycin M Injectable Product in people with Mental Health Issue, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 32 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yingyuan Zhang, Bachelor of Medicine (13917467481, yyzhang39@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical cure rate (mITT) (time frame: At TOC visit, which is 7-14 days after the end of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06198764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.

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