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A prospective, multicenter, randomized controlled, open clinical study on the efficacy and safety of aerosolized amphotericin B inhalation in the removal of airway candida in adult patients with severe mechanical ventilation

A prospective, multicenter, randomized controlled, open clinical study on the efficacy and safety of aerosolized amphotericin B inhalation in the removal of airway candida in adult patients with severe mechanical ventilation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073862
Enrollment
Unknown
Registered
2023-07-24
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Ventilator-associated Pneumonia (VAP)

Interventions

Rreatment group:Inhaled atomized amphotericin B
Control group:Inhalated sterilizing water for injection

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form (for those without the ability to sign, the entrusted party shall sign on behalf of them) and promise to follow the research procedures and cooperate in the implementation of the entire process of research 2. Age = 18 and = 85 3. Adult patients with mechanical ventilation = 72h 4. For patients with candida detected in the airway twice in a row (the inspection interval is more than 1 day), the inspection method is microscopic inspection or culture, and spores or mycelium detected can be considered as colonization 5.The time interval between enrollment and intervention treatment shall not exceed 24 hours

Exclusion criteria

Exclusion criteria: 1.Unable to obtain the informed consent of the subject, family members or authorized agents; 2.Patients with mechanical ventilation1 mg/kg) steroid drugs or use of other immunosuppressive drugs; 6.Suffer from ventilator associated pneumonia (VAP) recently (within 2 weeks); 7.Have received intravenous amphotericin B or nebulization (NAB) treatment within one month; 8.Patients receiving systemic antifungal treatment or more than 72h antifungal treatment within one week; 9.Subjects suffered from severe granulocytopenia (white blood cell count less than 500/mm3); 10.HIV infection; 11.BMI less than 15kg/m2; 12.Subjects are undergoing other clinical studies; 13.Pregnancy or breastfeeding; 14.Serious lung disease requires ECMO support; 15.Estimated survival time of ICU < 48h;

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
Incidence of VAP within 28 days;Mechanical ventilation time;The proportion and time of candida decolonized within 28 days; Organ function scores improved during follow-up (SOFA and APACHEII scores);Successful rate of ventilator weaning (28 days);ICU mortality;length of ICU stay;Incidence of candidiemia at 28 days;90-day all-cause mortality rate;

Countries

China

Contacts

Public ContactDechang Chen

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

18918520002@189.cn+86 189 1852 0002

Outcome results

None listed

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