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

NCT ID: NCT02603575

Last Updated: 2020-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Brief Summary

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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℃.

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Detailed Description

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Conditions

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Pneumocystis Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caspofungin and corticosteroids

patients treat with caspofungin and corticosteroids on the base of sulfanilamide

Group Type EXPERIMENTAL

caspofungin

Intervention Type DRUG

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

corticosteroids

Intervention Type DRUG

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

Sulfanilamides

Intervention Type DRUG

1.92g q8h

Caspofungin and no corticosteroids

patients treat with caspofungin on the base of sulfanilamide

Group Type ACTIVE_COMPARATOR

caspofungin

Intervention Type DRUG

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

Sulfanilamides

Intervention Type DRUG

1.92g q8h

corticosteroids and no caspofungin

patients treat with corticosteroids on the base of sulfanilamide

Group Type ACTIVE_COMPARATOR

corticosteroids

Intervention Type DRUG

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

Sulfanilamides

Intervention Type DRUG

1.92g q8h

no corticosteroids and no caspofungin

patients treat with sulfanilamide only

Group Type ACTIVE_COMPARATOR

Sulfanilamides

Intervention Type DRUG

1.92g q8h

Interventions

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caspofungin

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

Intervention Type DRUG

corticosteroids

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

Intervention Type DRUG

Sulfanilamides

1.92g q8h

Intervention Type DRUG

Other Intervention Names

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methylprednisolone

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hangyong He

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Chao Yang Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hangyong He, MM

Role: CONTACT

[email protected]
861013693585722

Facility Contacts

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Hangyong He, MM

Role: primary

[email protected]
861085231543

Other Identifiers

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BeijingCYHRICU01

Identifier Type: -

Identifier Source: org_study_id

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