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NCT02603575 Clinical Trial

Effects and Safety of Caspofungin and Corticosteroids in Pneumocystis Pneumonia in Non-HIV Patients

Pneumocystis Pneumonia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02603575
Other study ID # BeijingCYHRICU01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2015

Study information
Verified date January 2020
Source Beijing Chao Yang Hospital
Contact Hangyong He, MM
Phone 861013693585722
Email yonghang2004@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pneumocystis Pneumonia is increasing in Immunocompromised Non-HIV Infected Patients. The effects and safety of caspofungin and corticosteroids is not certain in this population. All Immunocompromised Non-HIV patients with respiratory failure were randomized into caspofungin and non-caspofungin group and corticosteroids and non-steroids group. The major outcome is 28 day mortality, the second outcome are time of respiratory rate decreases to less than 25 breath per minute, body temperature lower than 37.3℃.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Immunocompromised Non-HIV Infected Patients

- Partial arterial O2 pressure(PaO2)/FiO2=300mmHg

- Diagnosed as Pneumocystis Pneumonia

Exclusion Criteria:

- younger than 16 years old

- severe organ failure

- allergic to sulfanilamide, caspofungin or corticosteroid

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• caspofungin
70mg ivdrip the first day, then 50mg ivdrip qd
• corticosteroids
40mg ivdrip q12h for 5 days 40mg ivdrip qd for 5 days 20mg po for 11 days
• Sulfanilamides
1.92g q8h

Locations
Country Name City State
China Beijing Chao Yang Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality 28 days
Secondary Time for release of fever Time for body temperature less than 37.3? for 48 hours 2 days
Secondary Time for release of respiratory distress Time for respiratory rate <25 breathes per minute for 48 hours 2 days
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