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

Study Overview
=================
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℃.

Conditions
-----------------
Pneumocystis Pneumonia

Intervention / Treatment
-----------------
* Drug: caspofungin
* Drug: corticosteroids
* Drug: Sulfanilamides


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for release of fever | Time for body temperature less than 37.3℃ for 48 hours | 2 days | 
| Time for release of respiratory distress | Time for respiratory rate <25 breathes per minute for 48 hours | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caspofungin, corticosteroids, Pneumocystis Pneumonia, Immunocompromised, Non-HIV, respiratory failure