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

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02603575

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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℃.

Condition or Disease	Intervention/Treatment	Phase
Pneumocystis Pneumonia	Drug: caspofungin Drug: corticosteroids Drug: Sulfanilamides	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Caspofungin and corticosteroids patients treat with caspofungin and corticosteroids on the base of sulfanilamide	Drug: caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd Drug: corticosteroids 40mg ivdrip q12h for 5 days 40mg ivdrip qd for 5 days 20mg po for 11 days Other Names: methylprednisolone Drug: Sulfanilamides 1.92g q8h
Active Comparator: Caspofungin and no corticosteroids patients treat with caspofungin on the base of sulfanilamide	Drug: caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd Drug: Sulfanilamides 1.92g q8h
Active Comparator: corticosteroids and no caspofungin patients treat with corticosteroids on the base of sulfanilamide	Drug: corticosteroids 40mg ivdrip q12h for 5 days 40mg ivdrip qd for 5 days 20mg po for 11 days Other Names: methylprednisolone Drug: Sulfanilamides 1.92g q8h
Active Comparator: no corticosteroids and no caspofungin patients treat with sulfanilamide only	Drug: Sulfanilamides 1.92g q8h

Outcome Measures

Primary Outcome Measures

mortality [28 days]

Secondary Outcome Measures

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