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

March 11, 2020 updated by: Hangyong He, Beijing Chao Yang Hospital
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℃.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100020
        • Recruiting
        • Beijing Chao Yang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 8, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingCYHRICU01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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