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Status unknownNCT02603575Updated Mar 13, 2020

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

An interventional study of caspofungin and corticosteroids in Pneumocystis Pneumonia, sponsored by Beijing Chao Yang Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-03-13.

Sponsored by Beijing Chao Yang Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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℃.

02

Conditions studied

  • Pneumocystis Pneumonia

Keywords

  • Caspofungin
  • corticosteroids
  • Pneumocystis Pneumonia
  • Immunocompromised
  • Non-HIV
  • respiratory failure
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 60 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Beijing Chao Yang Hospital is the lead sponsor of 135 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Immunocompromised Non-HIV Infected Patients
  • Partial arterial O2 pressure(PaO2)/FiO2≤300mmHg
  • Diagnosed as Pneumocystis Pneumonia

Exclusion criteria

Exclusion Criteria:

  • younger than 16 years old
  • severe organ failure
  • allergic to sulfanilamide, caspofungin or corticosteroid
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Caspofungin and corticosteroids

    patients treat with caspofungin and corticosteroids on the base of sulfanilamide

    Drug: caspofungin · Drug: corticosteroids · Drug: Sulfanilamides

  • Active comparator
    Caspofungin and no corticosteroids

    patients treat with caspofungin on the base of sulfanilamide

    Drug: caspofungin · Drug: Sulfanilamides

  • Active comparator
    corticosteroids and no caspofungin

    patients treat with corticosteroids on the base of sulfanilamide

    Drug: corticosteroids · Drug: Sulfanilamides

  • Active comparator
    no corticosteroids and no caspofungin

    patients treat with sulfanilamide only

    Drug: Sulfanilamides

Interventions

  • Drugcaspofungin

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

  • Drugcorticosteroids

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

    Also known as: methylprednisolone

  • DrugSulfanilamides

    1.92g q8h

06

What researchers measure

Primary outcomes

  1. mortality

    Time frame: 28 days

Secondary outcomes

  1. Time for release of fever

    Time for body temperature less than 37.3℃ for 48 hours

    Time frame: 2 days

  2. Time for release of respiratory distress

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

    Time frame: 2 days

07

Study locations

1 of 1 sites recruiting
  • Beijing Chao Yang Hospital
    Beijing, 100020, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02603575
Lead sponsor
Beijing Chao Yang Hospital
Responsible party
Hangyong He (Doctor, Beijing Chao Yang Hospital) — Principal investigator
First posted
Nov 13, 2015
Start date
Nov 2015
Primary completion
Dec 2020 (estimated)
Last update
Mar 13, 2020

Study contacts

Hangyong He, MM
Contact
yonghang2004@sina.com
861013693585722
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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