Refractory lung infection mediated by multi-drug resistant bacteria
Conditions
Interventions
case series:Nil
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. The patient must be an inpatient, and the pulmonary infection needs to be given intravenous antimicrobial treatment after the clinician has assessed; 3. In addition to confirming pneumonia (CT or chest radiograph showing new or progressive lung infiltration, consistent with bacterial pneumonia), the patient's radiological examination should have at least one of the following clinical symptoms: a. New or worsening cough; b. Fever, mouth temperature or axillary temperature greater than 38°C (rectal or tympanic membrane temperature> 38.5 degrees C) or hypothermia (<= 35 degrees C); c. Pulmonary consolidation signs and (or) smell of wet accents; d. The white blood cell count is greater than 10 x 10^9/L or < 4 x 10^9/L, with or without nucleus shifting to the left e. Difficulty breathing, shortness of breath or hypoxemia (when the subject breathes indoor air under standard atmospheric pressure, the oxygen saturation measured by arterial blood gas is < 90% or PO2 < 60mmHg); 4. The patient needs to perform Gram staining and culture of respiratory tract specimens, and the specimen source is confirmed to be the lower respiratory tract before entering the group, and the bacterial culture results indicate multi-drug resistant Gram-negative bacilli infection; 5. Known or researchers believe that the infection is caused by microorganisms that are sensitive to polymyxin B; 6. Females of childbearing age and female subjects whose menopause time is less than 2 years must agree to take effective contraceptive measures during the study period and within six months after the end of the study; 7. Volunteer to participate and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of allergy to the test drug polymyxin B, or are known to be allergic to more than two drugs or food; 2. The patient's lung infiltration is caused by non-infectious causes (such as pulmonary embolism, aspiration chemical pneumonia, allergic pneumonia, congestive heart failure, etc.); 3. Consider those infected with Gram-positive bacteria or Gram-negative cocci based on the patient's clinical manifestations, physical signs, imaging examinations and laboratory examinations; 4. Atypical pathogen infections known or suspected based on epidemiological evidence (Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella, etc.); 5. Alanine aminotransferase or aspartate transferase > 3 x upper limit of normal value, and total bilirubin > 2 x upper limit of normal value; 6. Congestive heart failure, myocardial infarction, unstable angina, stroke or transient ischemic attack occurred within 12 weeks before enrollment; 7. Performing major surgery such as coronary artery reconstruction within 12 weeks before enrollment, or planning major surgery; 8. Have a history of organ transplantation; 9. Pregnant or lactating women; 10. Participated in other clinical trials and used experimental drugs within 3 months before the randomization of this study; 11. During the administration period, the myostatin muscle relaxant and other neurotoxic drugs cannot be stopped; 12. During the administration period, other drugs with nephrotoxicity cannot be stopped (such as bacitracin, streptomycin, neomycin, kanamycin, amikacin, gentamicin, tobramycin, cephalosporin Colimycin, paromomycin, puromycin and colistin); 13. Subjects received polymyxin B treatment for no more than 48 hours (intravenous injection of polymyxin B <= 4 times); 14. Subjects who have received aerosol inhalation of polymyxin B treatment before entering the group and the drug withdrawal time is <= 48h; 15. Other situations that the researcher thinks should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration; | — |
Countries
China
Contacts
Public ContactZhang Hong
Nanchang University
Outcome results
None listed