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The pharmacokinetics of optimized-dose Caspofungin in the empirical treatment of septic shock patients with high-risk invasive candidiasis factors

The pharmacokinetics of optimized-dose Caspofungin in the empirical treatment of septic shock patients with high-risk invasive candidiasis factors

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026998
Enrollment
Unknown
Registered
2019-10-28
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-11-04

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

Conditions

Sepsis

Interventions

Experiment group:Caspofungin (inject) first dose 100mg QD, maintenance 70mg QD
Control group:Caspofungin (inject) first dose 70mg QD, maintenance 50mg QD

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Meet the diagnostic criteria of septic shock in sepsis 3.0; 3. Satisfy the 2 points above, and any condition in the following criteria of suspected invasive candidiasis: (1) Administrating broad spectrum antibiotics >= 4 days but no significant improvement of infection in the last 7 days; (2) Candida score >= 3 points; (3) Multiple Candida spp. colonization; (4) G-test >= 80pg/ml; (5) ICU length of stay >= 4 days, mechanical ventilation (1-3 days), central venous catheter indwelling (1-3 days) and any conditions in the followinga. a. TPN (1-3 days); b. major surgery (in 7 days); c. CRRT(1-3 days; d. SAP(in 7 days).

Exclusion criteria

Exclusion criteria: 1. Dying state patients who expect to die or discharge or terminate life support in 48 hours; 2. Administrating echinocandin >= 1 days or other antifungal drugs >= 48 hours 7 days before enrollment; 3. Proven allergic or intolerant to echinocandin, unable to receive the treatment; 4. Agranulocytosis (WBC < 0.5x10^9 /L); 5. Bone marrow or organ transplantation; 6. Chemotherapy in the last 3 months; 7. Receiving immunosuppressive treatment, apart from prednisone < 2mg/kg/d or equivalent steroids; 8. Severe live function abnormalities (Child class C); 9. AIDS; 10. Pregnant or lactating female; 11. Participating in other clinical trails 1 month before enrollment, or already enrolled in this trail before.

Design outcomes

Primary

MeasureTime frame
fAUC?Cmax?Cmin;28-day candidiasis-free survival;

Countries

China

Contacts

Public ContactLi lifen

The First Affiliated Hospital of Sun Yat-Sen University

lilifengz@163.com+86 13822281788

Outcome results

None listed

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