Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSoutheast University, China

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • treatment with or without colistin

Treatment groups

404 Participants
are divided into 2 treatment groups

Sponsors and collaborators