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A multicenter, prospective, randomized, controlled clinical study of the decolonization effect of aerosol inhalation of colistin combined with intravenous tanreqing in artificial airway patients with Pseudomonas aeruginosa colonization in lower respiratory tract

A multicenter, prospective, randomized, controlled clinical study of the decolonization effect of aerosol inhalation of colistin combined with intravenous tanreqing in artificial airway patients with Pseudomonas aeruginosa colonization in lower respiratory tract

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059512
Enrollment
Unknown
Registered
2022-05-03
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

None listed

Interventions

Colistin combined with Tanreqing group:Colistin and Tanreqing
Colistin group:Aerosol inhalation of colistin
Tanreqing group: Intravenous Tanreqing

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 2 consecutive positive isolation of drug-resistant Pseudomonas aeruginosa in lower respiratory tract specimens(bronchial suction or bronchoscopy sampling) (drug resistance is defined as at least three kinds of antimicrobial resistance for the following drugs: cephalosporin, carbapenems, beta-lactamase inhibitor, fluoroquinolone, aminoglycoside), and clinically diagnosed as multidrug-resistant Pseudomonas aeruginosa colonization; 2. Patients with an artificial airway; 3. Patients requiring bronchoalveolar lavage for diagnosis and treatment; 4. patients with recent lung imaging and blood inflammation index examination results; 5. Informed consent signed by the patient himself or his legal guardian; 6. Patients aged >=18 years and <75 years.

Exclusion criteria

Exclusion criteria: 1. The presence of a lung infection (All the following manifestations are met: (1) New or progressive pulmonary infiltration, consolidation, or ground glass on chest X-ray or CT; (2) Meeting at least two of the following clinical characteristics: body temperature > 38?, peripheral white blood cells > 10x10^9/L or 2 times the upper limit of normal; 6. Using neurotoxic drugs; 7. Severe cor pulmonale with heart failure; 8. TCM syndrome differentiation belongs to the surface cold syndrome; 9. A history of intravenous or atomized inhalation of colistin sulfate within 3 days; 10. Patients requiring systematic treatment with antibacterial agents against Pseudomonas aeruginosa; 11. Patients who are concomitant or expected to use nephrotoxic drugs (e.g. vancomycin and aminoglycosides) during the study period; 12. Extubation is expected within 7 days; 13. Patients who cannot cooperate with atomizing inhalation therapy; 14. Patients who cannot receive bronchoalveolar lavage; 15. Any serious medical condition or mental disorder which, in the opinion of the investigator, may endanger the safety of the patient or interfere with the completion of treatment under this protocol; 16. Pregnant or lactating patients or patients of childbearing age who are trying to conceive.

Design outcomes

Primary

MeasureTime frame
Proportion of Pseudomonas aeruginosa load in lower respiratory tract specimens cultured within 24 h of the end of last treatment compared to baseline;

Countries

China

Contacts

Public ContactZhang Jing
zhangj_fudan@aliyun.com+86 21 52888190

Outcome results

None listed

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