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Efficacy and safety of standard intravenous antibiotic regimens in patients with mechanically ventilated gram-negative bacterial pneumonia treated with aerosolized colistin sulfate: a randomized, double-blind, placebo-controlled clinical study

Efficacy and safety of standard intravenous antibiotic regimens in patients with mechanically ventilated gram-negative bacterial pneumonia treated with aerosolized colistin sulfate: a randomized, double-blind, placebo-controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036426
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical ventilation gram-negative bacterial pneumonia

Interventions

Case series:Combined with atomized colistin sulfate for ten days

Sponsors

Ruijin Hospital affiliated to Shanghai Jiao Tong University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 to 80 years; 2. Patients on mechanical ventilation (oral or nasal intubation or tracheotomy); 3. Diagnosis consistent with pneumonia (chest imaging confirmed new infiltrates in both lungs) and APACHEII score greater than 15; 4. Confirmed or suspected gram-negative pulmonary bacteria (from lower respiratory tract, alveolar lavage fluid or protective hair brush): smear or culture of lower respiratory tract specimens. Definition of MDR pathogenic bacteria: -lactams, including penicillins, cephalosporins, and monobatans; Carbapenems; Resistance to two or more quinolones and aminoglycosides; 5. The lower respiratory tract secretions have high risk factors of MDR gram-negative bacteria or at least two MDR Gram-negative bacteria infections. Risk factors for suspected infection include: (1) Antibiotic use within 2 weeks (2) Stay in hospital for 5 days or more (3) Patients in wards or communities with high drug resistance rates (> 10%) (4) Immunosuppressive diseases or treatments (5) HCAP risk factors: previous 90-day hospital stay of 2 days or more; From a nursing home or institution;Home care; Chronic dialysis within 30 days; Home wound care; Family members have MDR pathogenic bacteria; 6. Oxygenation index less than 300 within 48h; 7. APACHE II score is 12 or above; 8. CPIS score greater than or equal to 6 within 48 hours; 9. Sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. pregnancy; 2. Previous history of polymyxin-E hypersensitivity; 3. Patients with intravenous antibiotics longer than 48 hours may be enrolled if gram-negative bacteria are resistant to the antibiotics previously used; 4. No operation or other tumor metastasis or bronchial obstruction in primary lung cancer; 5. Serum creatinine level greater than 2 mg/dL (177 mol/L), except if the patient is treated with CVVH or CVVHDF; 6. Pulmonary active tuberculosis, cystic fibrosis, HIV infection with CD4 T cell count less than 200 cells /mm3, invasive pulmonary candida infection, or pulmonary abscess and empyema; 7. Staphylococcus aureus bacteremia; 8. Burn patients with body surface area greater than 40%; 9. Granulocytosis (absolute count of granulocytes & LT;Neutrophils 103 cells/mm3); 10. Mechanical ventilation over 28 days; 11. Expected death within 72 hours; 12. Stem cell transplantation; 13. Patients with Legionella infection; 14. Patients treated with ECMO.

Design outcomes

Primary

MeasureTime frame
Before the experiment, the infection indexes, etiology and viscera functions of the patients were examined.D3, 5 and D10 to examine the patient's chest CT, etiology and viscera function;Follow-up D28 day;

Countries

China

Contacts

Public ContactLiu Jiao

Ruijin Hospital affiliated to Shanghai Jiao Tong University Medical College

catherine015@163.com+86 18121266339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026