NCT02603575

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℃.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

March 13, 2020

Status Verified

January 1, 2020

Enrollment Period

5.1 years

First QC Date

November 8, 2015

Last Update Submit

March 11, 2020

Conditions

Pneumocystis Pneumonia

Keywords

CaspofungincorticosteroidsPneumocystis PneumoniaImmunocompromisedNon-HIVrespiratory failure

Outcome Measures

Primary Outcomes (1)

  • mortality

    28 days

Secondary Outcomes (2)

  • Time for release of fever

    2 days

  • Time for release of respiratory distress

    2 days

Study Arms (4)

Caspofungin and corticosteroids

EXPERIMENTAL

patients treat with caspofungin and corticosteroids on the base of sulfanilamide

Drug: caspofunginDrug: corticosteroidsDrug: Sulfanilamides

Caspofungin and no corticosteroids

ACTIVE COMPARATOR

patients treat with caspofungin on the base of sulfanilamide

Drug: caspofunginDrug: Sulfanilamides

corticosteroids and no caspofungin

ACTIVE COMPARATOR

patients treat with corticosteroids on the base of sulfanilamide

Drug: corticosteroidsDrug: Sulfanilamides

no corticosteroids and no caspofungin

ACTIVE COMPARATOR

patients treat with sulfanilamide only

Drug: Sulfanilamides

Interventions

caspofunginDRUG

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

Caspofungin and corticosteroidsCaspofungin and no corticosteroids
corticosteroidsDRUG

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

Also known as: methylprednisolone
Caspofungin and corticosteroidscorticosteroids and no caspofungin
SulfanilamidesDRUG

1.92g q8h

Caspofungin and corticosteroidsCaspofungin and no corticosteroidscorticosteroids and no caspofunginno corticosteroids and no caspofungin

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, 100020, China

RECRUITING

MeSH Terms

Conditions

Pneumonia, PneumocystisRespiratory Insufficiency

Interventions

CaspofunginAdrenal Cortex HormonesMethylprednisoloneSulfanilamides

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, CyclicHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Central Study Contacts

Hangyong He, MM

CONTACT

861013693585722yonghang2004@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 8, 2015

First Posted

November 13, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2020

Last Updated

March 13, 2020

Record last verified: 2020-01

Locations

CN(1)