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Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis in Patients with Chronic Obstructive Pulmonary Disease -- A prospective, open-label, single-arm, single-center clinical study

Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis in Patients with Chronic Obstructive Pulmonary Disease -- A prospective, open-label, single-arm, single-center clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079780
Enrollment
Unknown
Registered
2024-01-11
Start date
2012-03-08
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Invasive Pulmonary Aspergillosis

Interventions

Patients with COPD combined with IPA:A single 70mg loading dose of cappofungin acetate for injection was given on the first day, and then 50mg daily for the following 20 days. It takes about 1 hour to

Sponsors

the First Affiliated Hospital of Guangzhou Medical University/State Key Laboratory of Respiratory Disease
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Resident patients diagnosed or clinically diagnosed with COPD combined with IPA according to the EORTC-MSG criteria; 2. Male or female patients over 18 years old; 3. Inpatients; 4. The subject (or their legal representative) has signed the informed consent form; 5. If the female subject is a woman of childbearing age, the urine pregnancy test must be negative at screening and agree to take safe and effective contraceptive measures during the whole process; 6. Did not participate in other clinical drug studies within 14 days; 7. No empirical echinocandin antifungal treatment within 72 hours before enrollment; 8. No prophylactic intravenous antifungal therapy was used (except for fluconazole or oral antifungal agents) before enrollment. Concomitant treatment All non-study drugs (prescription or over-the-counter drugs, purchased from hospitals or from pharmacies), including topical antifungals, whether already used before the study or only after entering the trial, must be documented in the concomitant medication form of the CRF.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of allergy or intolerance of echinocandin antifungals; 2. Patients suspected of being allergic to the studied drugs or drug relief ingredients; 3. Pregnant or lactating women, and women eligible who did not take appropriate contraceptive measures during the study; 4. Those who have been treated with other antifungal drugs for this disease, or need to be combined with other antifungal drugs (except for local use of antifungal drugs); 5. The patients are currently diagnosed with: malignant tumor, active viral hepatitis, severe renal insufficiency (serum creatinine clearance <30 ml/min), severe liver dysfunction or severe liver insufficiency, HIV infection, fungal infection of the central nervous system, and uncontrolled bacterial infection; 6. Other serious systemic diseases, as judged by the investigator, will affect the evaluation of the results of the study.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy (within 3 weeks);

Secondary

MeasureTime frame
One week clinical efficacy;mortality;drug sensitivity;

Countries

China

Contacts

Public ContactFeng Ye

The First Affiliated Hospital of Guangzhou Medical University

yefeng@gird.cn+86 189 2886 8221

Outcome results

None listed

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