Pulmonary infections mediated by multidrug-resistant Gram-negative bacteria
Conditions
Interventions
Observation group of refractory pulmonary infection mediated by multidrug-resistant Gram-negative bacteria:None
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. The patient must be an inpatient, and the clinical physician has evaluated that the patient's pulmonary infection requires intravenous antimicrobial drug treatment; 3. In addition to confirming pneumonia (as shown by CT or chest X-ray with new or progressive pulmonary infiltrates, consistent with bacterial pneumonia), the patient's radiological examination should have at least one of the following clinical symptoms: a. New or aggravated cough; b. Fever, with oral or axillary temperature greater than 38? (rectal or tympanic temperature > 38.5?) or hypothermia (<= 35?); c. Bronchial consolidation signs and/or wet rales heard; d. White blood cell count greater than 10×10^9/L or less than 4×10^9/L, accompanied or not by nuclear left shift; e. Dyspnea, shortness of breath or hypoxemia (when the subject breathes indoor air under standard atmospheric pressure, oxygen saturation < 90% by arterial blood gas measurement < 60mmHg); 4. The patient needs to undergo Gram staining and culture of respiratory tract specimens, and it should be confirmed before enrollment that the specimen source is the lower respiratory tract, and the bacterial culture result indicates multi-drug resistant Gram-negative bacillus infection; 5. Known or as determined by the investigator, the infection is caused by microorganisms sensitive to colistin; 6. Pregnant women and women with a short duration of menopause (less than 2 years) must agree to take effective contraceptive measures during the study period and for the next six months after the study; 7. Intravenous administration of colistin for more than 5 doses; 8. Colistin TDM monitoring (blood sampling for detection at 0h before the next administration, 0.5h after administration, 2h, 4h, 8h, 24h after administration after 5 doses of administration)
Exclusion criteria
Exclusion criteria: 1. Those with a history of allergy to the experimental drug colistin, or who are known to be allergic to two or more drugs and foods; 2. Patients with pulmonary infiltration caused by non-infectious reasons (such as pulmonary embolism, inhalation chemical pneumonia, allergic pneumonia, congestive heart failure, etc.); 3. Those considered to be infected with Gram-positive or Gram-negative cocci based on the patient's clinical manifestations, physical signs, imaging examinations and laboratory tests; 4. Known or suspected atypical pathogen infections (such as Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella species, etc.); 5. Alanine aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal value, and total bilirubin > 2 times the upper limit of normal value; 6. Within the 12 weeks prior to enrollment, patients experienced congestive heart failure, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack; 7. Within the 12 weeks prior to enrollment, underwent major surgeries such as coronary artery revascularization, or planned to undergo major surgeries; 8. Have a history of organ transplantation; 9. Pregnant or lactating women; 10. Those who participated in other clinical trials and used the experimental drug within 3 months before randomization of this study; 11. Those who cannot discontinue succinylcholine muscle relaxants and other neurotoxic drugs during the administration period; 12. Those who cannot discontinue other drugs with nephrotoxicity during the administration period (such as bacitracin, streptomycin, neomycin, kanamycin, amikacin, gentamicin, tobramycin, cephalosporins, balanomycin, erythromycin and polymyxin B); 13. The duration of colistin treatment for the subject does not exceed 48 hours (intravenous colistin <= 4 times).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness evaluation (clinical outcomes, microbial clearance rate);Safety assessment (adverse reaction situation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic drug monitoring; | — |
Countries
China
Contacts
Public ContactJinfang Hu
The First Affiliated Hospital of Nanchang University
Outcome results
None listed