Carbapenem-Resistant Enterobacteriaceae InfectionNCT06051513
Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection
A study testing treatment with or without colistin in people with Carbapenem-Resistant Enterobacteriaceae Infection, run by Southeast University, China at 15 sites in China.
Trial summary
Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae Infection
- What is being tested?
- treatment with or without colistin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 15 sitesChina
- Study dates
- 27 Nov 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who can provide written informed consent or their informed consent can be provided by legal guardian
- Patients who are hospitalized
- Adults ≥18 years and ≤85 years of age
- Patients suspected of or diagnosed with hospital-acquired pneumonia (HAP, in a patient hospitalised for more than 48 hours or developing within 7 days after discharge from a hospital) or bloodstream infection caused carbapenem-resistant enterobacteriaceae (CRE) based on the culture results of the sample collected 5 days before the randomization or rapid diagnostic detection.
- Rapid testing of respiratory or blood specimens should be used to enable early identification of CRE infection pneumonia. Patients can be randomized based on the results of the rapid test while awaiting results of cultures from the local laboratory. However, if the sample does not grow CRE in the local microbiology laboratory culture, these patients will be withdrawn from the study drug treatment.
- Patients with HAP should fulfil one of the following systemic signs: 1)Fever (temperature >38°C) or hypothermia (rectal/core temperature <35°C);2)White blood cell (WBC) count >10,000 cells/mm3, or WBC count <4500 cells/mm3, or >15% band forms and fulfil at least two of the following respiratory signs or symptoms:1)a new onset of cough (or worsening of cough);2)production of purulent sputum or endotracheal secretions;3)auscultatory findings consistent with pneumonia/pulmonary consolidation (e.g., rales, rhonchi, bronchial breath sounds, dullness to percussion, egophony);4)dyspnoea, tachypnoea or hypoxaemia (O2 saturation <90% or pO2 <60 mmHg while breathing room air).
Show all 9Show fewer
- Patients with bloodstream infection should fulfil one of the following criterion:1)fever(≥38 ℃);2)chills;3)hypotension(systolic <90 mmHg, requiring vasopressors to maintain mean arterial pressure ≥60 mmHg,decreased by 30mmHg from baseline) ,and isolation of CRE from at least two blood culture collected from two different sites.
- Respiratory or blood specimen obtained for culture within 5 days prior to randomization, and after the onset of signs and symptoms of HAP or bloodstream infection (ideally before receipt of any systemic antibiotics).
- Patients whose APACHE II score is between 10 and 30.
Who cannot join
- Patients who received polymyxin for more than 48 hours in the 72 hours prior to randomization.
- Patients who received antibiotics more than 24 hours in the 72 hours prior to randomization, and after treatment，conditions of patients improved.
- Patient with history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to Colistimethate Sodium for Injection or other ingredients of it.
- Evidence of active concurrent pneumonia requiring additional antimicrobials treatment caused by Streptococcus pneumoniae，Haemophilus influenzae，Methicillin-resistant staphylococcus aureus，Vancomycin-resistant enterococcus，Mycoplasma pneumonia，Legionella pneumophila, respiratory syncytial virus, influenza virus, parainfluenza virus, Middle East Respiratory Virus, Mycobacteria, Aspergillus, Mucormycosis, Candida,etc. If these organisms are identified but it is deemed by the Investigator that no treatment is warranted and their presence does not significantly change the prognosis of the patient, then the patient may be considered for this study.
- Patients who are diagnosed with primary lung cancer (including small cell lung cancer/non-small cell lung cancer patients) or other malignancy transferred to the lungs or other known post obstructive pneumonia. Patients who is known or suspected of active tuberculosis, cystic fibrosis, lung abscess, pyothorax or obstructive pneumonia.
- Patients with hematological malignancy such as leukemia, lymphoma and multiple myeloma.
Show all 14Show fewer
- Patients with lung/heart transplantation or stem cell transplantation.
- Patient was immunocompromised and at risk of infection by opportunistic pathogens including, but not limited to the following:1) HIV (AIDS or CD4 <200). 2) chemoradiotherapy within 3 months prior to randomisation. 3) Immunosuppressive therapy including maintenance corticosteroids (0.5 mg/kg prednisone per day or other equivalent glucocorticoid). 4) Absolute neutrophil count <500/mm3.
- Patients with chronic liver failure with portal hypertension, acute hepatic failure or acute decompensation of chronic hepatic failure.
- Patients who participated in other clinical trials within three months.
- Patient was pregnant or breastfeeding. If either urine or serum β-hCG test was positive, the patient was excluded.
- Patient who have been previously enrolled in this study.
- Patients who have condionts that may affect the trial.
- Other conditions exist researchers thought are not suitable.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Anhui Provincial People's Hospital
Hefei, Anhui, 230000
Aijun, Pan, +8613866668786
- Recruiting
The First Hospital of Anhui Medical University
Hefei, Anhui, 230000
Min Shao, +8615656065677
- Recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu, 223000
Xiangcheng Zhang, +8615896169171
- Recruiting
Jinjiang Municipal Hospitall
Jinjiang, Fujian, 362200
Sen Lin, +8618065956302
- Recruiting
The First Hospital of Lianyungang
Lianyungang, Jiangsu, 222000
Suxia Liu, +8618961326708
- Recruiting
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, 210000
Yingzi Huang, +86-25-83262552, yz_huang@126.com
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
Hongsheng Zhao, +8613962918910
- Recruiting
Suzhou Municipal Hospitial
Suzhou, Jiangsu, 215000
Liu Jun
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Jun Jin, +8613806214010
- Recruiting
JiangsuTaizhou People's Hospital
Taizhou, Jiangsu, 225300
Jilu Ye, +8613852609309
- Recruiting
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 214000
Liang Luo, +8615961790376
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Jiaqiong Li, +8618952170393
- Recruiting
Yancheng No.1 People's Hospital
Yancheng, Jiangsu, 224000
Genghua Mu, +8613815584925
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
Ruiqiang Zheng, +8613952721411
- Recruiting
Yixing People's Hospital
Yixing, Jiangsu, 214000
Junjie Lu, +8613606157979
About this study
Official title: Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection：a Prospective, Open-label, Randomized Controlled, Multicenter Clinical Trial
Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin, however in another group, the patients accept treatment without colistin. The efficacy and safety of the treatment between the two groups are compared.
Read the detailed description
The study will be conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE from 14 centres in China will be recruited. All patients will be randomized to receive treatment with or without colistin in the ICU. The purpose of this study is to investigate the efficacy and safety of colistin when used to treat patients with CRE infection. The primary outcome is 14-day all cause mortality and the second outcomes include 14-day clinical cure rate, 14-day efficacy rate, ICU free days within 28 days after randomization，14-day microbiological cure rate，incidence of adverse events and severe adverse events in first 14 days, hospital mortality, 28-day all cause mortality, ICU mortality. Clopper-Pearson method is used to calculate the 95% confidence interval of mortality, Miettinen and Nurminen method is used to detect the difference between the two groups.
- Being tested
- treatment with or without colistin
- Keywords
- Colistimethate Sodium for Injection, Hospital-acquired pneumonia, Bloodstream infection, Carbapenem-resistant Enterobacteriaceae
- Medical subject headings
- Healthcare-Associated Pneumonia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with or without colistinDrug
For patients in this treatment group, colistin based therapy is used. Colistin combined with metroperan or imipenem（MIC≤8mg/L），or colistin combined with tigecycline, or colistin combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae. For patients in the control, best available treatment without colistin is uesed; Ceftazidime-avibactam, tigecycline combined with metroperan or imipenem（MIC≤8mg/L）, tigecycline combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae.
| Study group | Role | What they receive |
|---|---|---|
| colistin group | Experimental | For patients in this group, colistin based therapy is used. Colistin combined with metroperan or imipenem（MIC≤8mg/L），or colistin combined with tigecycline, or colistin combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae.
At the beginning of the intravenous use of Colistimethate Sodium for Injection，the load dose is 300mg CBA(about 9 million U)，and after 12-24 hours，the first maintenance dose should be given. The daily maintenance dose was 300-360mg CBA(9 million-10.9 million U), divided into two times (1/12h), for each time, 0.5-1 hour is needed to complete the infusion.
Drug: colistin, other name: Colistimethate Sodium for Injection Receives: Drug: treatment with or without colistin |
| control group | Active comparator | For patients in this group,best available treatment without colistin is used. Ceftazidime-avibactam, tigecycline combined with metroperan or imipenem（MIC≤8mg/L）, tigecycline combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae.Dose of other drugs are listed below: 1-2g meropenem should be given every 8 hours，1g Imipenem every 8 hours or 6 hours，0.8g Amikacin everyday，2.5g ceftazidime-avibactam every 8 hours. A load dose of 200mg tigecycline is needed, followed by 100mg every 12 hours. Receives: Drug: treatment with or without colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-day all cause mortality
the proportion of subjects who die within 14 days after randomization to the number of subjects in each group
Measured: from randomization to day 14
Secondary outcomes (8)
14-day clinical cure rate
the proportion of subjects who are thought as clinical effectiveness 14 days after randomization to the number of subjects in each group.
Measured: from randomization to day 14
14-day efficacy rate
the proportion of subjects of who are thought as recovery 14 days after randomization to the number of subjects in each group.
Measured: from randomization to day 14
ICU free days within 28 days after randomization
days that patients are not treated in ICU within 28 days after randomization of each patient in each group. If the patient die within 28 days, it will be zero.
Measured: from randomization to day 28
14-day microbiological cure rate
the proportion of subjects of microbiological cure to the number of subjects in each group 14 days after randomization.
Measured: from randomization to day 14
incidence of adverse events and severe adverse events within first 28 days
the proportion of patients who experience adverse events and severe adverse events within 14 days after randomization to the number of subjects in each group wihtin first 14 days
Measured: from randomization to day 28
hospital mortality
the proportion of subjects who die when treated in hospital to the number of subjects in each group
Measured: to be evaluated up to 90 days post randomization
28-day all cause mortality
the proportion of subjects who die within 28 days after randomization to the number of subjects in each group
Measured: from randomization to day 28
ICU mortality
the proportion of subjects who die in ICU to the number of subjects in each group
Measured: to be evaluated up to 90 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start27 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carbapenem-Resistant Enterobacteriaceae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Yingzi Huang, MD, Study chair, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051513
- Sponsor's protocol ID
- COUNT-CRE
- Status last verified
- May 2025
- First submitted
- 7 Sep 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Zhang C, Li J, Chen T, Xie J, Huang Y. Multicentre open-label randomised controlled trial comparing the efficacy and safety of colistin-based combination therapy with the best available therapy for treating hospital-acquired pneumonia or bloodstream infections caused by carbapenem-resistant Enterobacteriaceae (COUNT-CRE): a study protocol. BMJ Open. 2025 Jul 16;15(7):e092157. doi: 10.1136/bmjopen-2024-092157.
PubMed 40669898
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection：a Prospective, Open-label, Randomized Controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT06051513
- Acronym / sponsor ID
- COUNT-CRE
- Keywords
- Colistimethate Sodium for Injection, Hospital-acquired pneumonia, Bloodstream infection, Carbapenem-resistant Enterobacteriaceae
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin, however in another group, the patients accept treatment without colistin. The efficacy and safety of the treatment between the two groups are compared.
Detailed description
The study will be conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE from 14 centres in China will be recruited. All patients will be randomized to receive treatment with or without colistin in the ICU. The purpose of this study is to investigate the efficacy and safety of colistin when used to treat patients with CRE infection. The primary outcome is 14-day all cause mortality and the second outcomes include 14-day clinical cure rate, 14-day efficacy rate, ICU free days within 28 days after randomization，14-day microbiological cure rate，incidence of adverse events and severe adverse events in first 14 days, hospital mortality, 28-day all cause mortality, ICU mortality. Clopper-Pearson method is used to calculate the 95% confidence interval of mortality, Miettinen and Nurminen method is used to detect the difference between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colistin group | Experimental | Drug: treatment with or without colistinFor patients in this group, colistin based therapy is used. Colistin combined with metroperan or imipenem（MIC≤8mg/L），or colistin combined with tigecycline, or colistin combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae. At the beginning of the intravenous use of Colistimethate Sodium for Injection，the load dose is 300mg CBA(about 9 million U)，and after 12-24 hours，the first maintenance dose should be given. The daily maintenance dose was 300-360mg CBA(9 million-10.9 million U), divided into two times (1/12h), for each time, 0.5-1 hour is needed to complete the infusion. Drug: colistin, other name: Colistimethate Sodium for Injection |
| control group | Active comparator | Drug: treatment with or without colistinFor patients in this group,best available treatment without colistin is used. Ceftazidime-avibactam, tigecycline combined with metroperan or imipenem（MIC≤8mg/L）, tigecycline combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae.Dose of other drugs are listed below: 1-2g meropenem should be given every 8 hours，1g Imipenem every 8 hours or 6 hours，0.8g Amikacin everyday，2.5g ceftazidime-avibactam every 8 hours. A load dose of 200mg tigecycline is needed, followed by 100mg every 12 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who can provide written informed consent or their informed consent can be provided by legal guardian
- Patients who are hospitalized
- Adults ≥18 years and ≤85 years of age
- Patients suspected of or diagnosed with hospital-acquired pneumonia (HAP, in a patient hospitalised for more than 48 hours or developing within 7 days after discharge from a hospital) or bloodstream infection caused carbapenem-resistant enterobacteriaceae (CRE) based on the culture results of the sample collected 5 days before the randomization or rapid diagnostic detection.
- Rapid testing of respiratory or blood specimens should be used to enable early identification of CRE infection pneumonia. Patients can be randomized based on the results of the rapid test while awaiting results of cultures from the local laboratory. However, if the sample does not grow CRE in the local microbiology laboratory culture, these patients will be withdrawn from the study drug treatment.
Key exclusion criteria (14 listed)
- Patients who received polymyxin for more than 48 hours in the 72 hours prior to randomization.
- Patients who received antibiotics more than 24 hours in the 72 hours prior to randomization, and after treatment，conditions of patients improved.
- Patient with history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to Colistimethate Sodium for Injection or other ingredients of it.
- Evidence of active concurrent pneumonia requiring additional antimicrobials treatment caused by Streptococcus pneumoniae，Haemophilus influenzae，Methicillin-resistant staphylococcus aureus，Vancomycin-resistant enterococcus，Mycoplasma pneumonia，Legionella pneumophila, respiratory syncytial virus, influenza virus, parainfluenza virus, Middle East Respiratory Virus, Mycobacteria, Aspergillus, Mucormycosis, Candida,etc. If these organisms are identified but it is deemed by the Investigator that no treatment is warranted and their presence does not significantly change the prognosis of the patient, then the patient may be considered for this study.
- Patients who are diagnosed with primary lung cancer (including small cell lung cancer/non-small cell lung cancer patients) or other malignancy transferred to the lungs or other known post obstructive pneumonia. Patients who is known or suspected of active tuberculosis, cystic fibrosis, lung abscess, pyothorax or obstructive pneumonia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment with or without colistinFor patients in this treatment group, colistin based therapy is used. Colistin combined with metroperan or imipenem（MIC≤8mg/L），or colistin combined with tigecycline, or colistin combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae. For patients in the control, best available treatment without colistin is uesed; Ceftazidime-avibactam, tigecycline combined with metroperan or imipenem（MIC≤8mg/L）, tigecycline combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae. | Drug | colistin group, control group |
Primary outcome
14-day all cause mortality
Time frame: from randomization to day 14
the proportion of subjects who die within 14 days after randomization to the number of subjects in each group
8 secondary outcomes
14-day clinical cure rate
Time frame: from randomization to day 14
14-day efficacy rate
Time frame: from randomization to day 14
ICU free days within 28 days after randomization
Time frame: from randomization to day 28
14-day microbiological cure rate
Time frame: from randomization to day 14
incidence of adverse events and severe adverse events within first 28 days
Time frame: from randomization to day 28
hospital mortality
Time frame: to be evaluated up to 90 days post randomization
28-day all cause mortality
Time frame: from randomization to day 28
ICU mortality
Time frame: to be evaluated up to 90 days post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 40669898Li X, Zhang C, Li J, Chen T, Xie J, Huang Y. Multicentre open-label randomised controlled trial comparing the efficacy and safety of colistin-based combination therapy with the best available therapy for treating hospital-acquired pneumonia or bloodstream infections caused by carbapenem-resistant Enterobacteriaceae (COUNT-CRE): a study protocol. BMJ Open. 2025 Jul 16;15(7):e092157. doi: 10.1136/bmjopen-2024-092157.
- Individual participant dataSharing planned: No
Related trials for Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingObservational study
Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae
Hemato-oncologic Patients, Colonization
Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
Active, not recruiting
Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales
Enterobacteriaceae Infections, Carrier State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yingzi Huang, MD study chair
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment with or without colistin in people with Carbapenem-Resistant Enterobacteriaceae Infection, run by Southeast University, China at 15 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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingzi Huang, MD (+86-025-83262552, yz_huang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-day all cause mortality (time frame: from randomization to day 14). 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 NCT06051513, which also lists 1 linked publication.
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 18 May 2025.