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

Not Applicable

• Conditions: Pneumocystis Pneumonia
• Interventions: Drug: Sulfanilamides; Drug: caspofungin; Drug: corticosteroids

• Registration Number: NCT02603575
• Lead Sponsor: Beijing Chao Yang Hospital

Brief 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℃.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-08
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-13
• Status Verified: 2020-01
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-13
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Caspofungin and corticosteroids	corticosteroids	patients treat with caspofungin and corticosteroids on the base of sulfanilamide
no corticosteroids and no caspofungin	Sulfanilamides	patients treat with sulfanilamide only
corticosteroids and no caspofungin	corticosteroids	patients treat with corticosteroids on the base of sulfanilamide
Caspofungin and no corticosteroids	Sulfanilamides	patients treat with caspofungin on the base of sulfanilamide
corticosteroids and no caspofungin	Sulfanilamides	patients treat with corticosteroids on the base of sulfanilamide
Caspofungin and corticosteroids	Sulfanilamides	patients treat with caspofungin and corticosteroids on the base of sulfanilamide
Caspofungin and corticosteroids	caspofungin	patients treat with caspofungin and corticosteroids on the base of sulfanilamide
Caspofungin and no corticosteroids	caspofungin	patients treat with caspofungin on the base of sulfanilamide

Primary Outcome Measures

Name	Time	Method
mortality	28 days

Secondary Outcome Measures

Name	Time	Method
Time for release of fever	2 days	Time for body temperature less than 37.3℃ for 48 hours
Time for release of respiratory distress	2 days	Time for respiratory rate \<25 breathes per minute for 48 hours

Trial Locations

Locations (1)

Beijing Chao Yang Hospital; 🇨🇳 Beijing, China