Back to results

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

Primary Purpose

Pneumocystis Pneumonia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

caspofungin

corticosteroids

Sulfanilamides

About this trial

This is an interventional treatment trial for Pneumocystis Pneumonia focused on measuring Caspofungin, corticosteroids, Pneumocystis Pneumonia, Immunocompromised, Non-HIV, respiratory failure

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Chao Yang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Caspofungin and corticosteroids

Caspofungin and no corticosteroids

corticosteroids and no caspofungin

no corticosteroids and no caspofungin

Arm Description

patients treat with caspofungin and corticosteroids on the base of sulfanilamide

patients treat with caspofungin on the base of sulfanilamide

patients treat with corticosteroids on the base of sulfanilamide

patients treat with sulfanilamide only

Outcomes

Primary Outcome Measures

mortality

Secondary Outcome Measures

Time for release of fever

Time for body temperature less than 37.3℃ for 48 hours

Time for release of respiratory distress

Time for respiratory rate <25 breathes per minute for 48 hours

Full Information

NCT ID

NCT02603575

First Posted

November 8, 2015

Last Updated

March 11, 2020

Sponsor

Beijing Chao Yang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02603575

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Chao Yang Hospital

4. Oversight

5. 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℃.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumocystis Pneumonia

Keywords

Caspofungin, corticosteroids, Pneumocystis Pneumonia, Immunocompromised, Non-HIV, respiratory failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Caspofungin and corticosteroids

Arm Type

Experimental

Arm Description

patients treat with caspofungin and corticosteroids on the base of sulfanilamide

Arm Title

Caspofungin and no corticosteroids

Arm Type

Active Comparator

Arm Description

patients treat with caspofungin on the base of sulfanilamide

Arm Title

corticosteroids and no caspofungin

Arm Type

Active Comparator

Arm Description

patients treat with corticosteroids on the base of sulfanilamide

Arm Title

no corticosteroids and no caspofungin

Arm Type

Active Comparator

Arm Description

patients treat with sulfanilamide only

Intervention Type

Drug

Intervention Name(s)

caspofungin

Intervention Description

70mg ivdrip the first day, then 50mg ivdrip qd

Intervention Type

Drug

Intervention Name(s)

corticosteroids

Other Intervention Name(s)

methylprednisolone

Intervention Description

40mg ivdrip q12h for 5 days 40mg ivdrip qd for 5 days 20mg po for 11 days

Intervention Type

Drug

Intervention Name(s)

Sulfanilamides

Intervention Description

1.92g q8h

Primary Outcome Measure Information:

Title

mortality

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Time for release of fever

Description

Time for body temperature less than 37.3℃ for 48 hours

Time Frame

2 days

Title

Time for release of respiratory distress

Description

Time for respiratory rate <25 breathes per minute for 48 hours

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hangyong He, MM

Phone

861013693585722

yonghang2004@sina.com

Facility Information:

Facility Name

Beijing Chao Yang Hospital

City

Beijing

ZIP/Postal Code

100020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hangyong He, MM

Phone

861085231543

cyh_birm@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs