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Tests treatment safety and results for Carbapenem-Resistant Enterobacteriaceae Infection
Official title Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection
ClinicalTrials.gov ID: NCT06051513
What this study is testing
What is treatment with or without colistin?
treatment with or without colistin is an investigational medicine, being studied as a potential treatment for carbapenem-resistant enterobacteriaceae infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Respiratory or blood specimen obtained for culture within 5 days prior to randomization, and after the onset of signs and symptoms of HAP or...
You likely can't join if
- 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...
- Evidence of active concurrent pneumonia requiring additional antimicrobials treatment caused by Streptococcus pneumoniae，Haemophilus...
- Patients who are diagnosed with primary lung cancer (including small cell lung cancer/non-small cell lung cancer patients) or other malignancy...
- Patients with hematological malignancy such as leukemia, lymphoma and multiple myeloma.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- Patients with hematological malignancy such as leukemia, lymphoma and multiple myeloma.
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Jinjiang, Fujian, China
- Huai'an, Jiangsu, China
- Lianyungang, Jiangsu, China
- Nanjing, Jiangsu, China
- Nantong, Jiangsu, China
- Suzhou, Jiangsu, China
- Taizhou, Jiangsu, China
- Wuxi, Jiangsu, China
- Xuzhou, Jiangsu, China
- Yancheng, Jiangsu, China
- Yangzhou, Jiangsu, China
- Yixing, Jiangsu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Jinjiang, Fujian, China; Huai'an, Jiangsu, China; Lianyungang, Jiangsu, China; Nanjing, Jiangsu, China; Nantong, Jiangsu, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.