Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 5 for:    "Lung Disease" | "Caspofungin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603575
Recruitment Status : Unknown
Verified November 2015 by Hangyong He, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : November 13, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Hangyong He, Beijing Chao Yang Hospital

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℃.

Condition or disease Intervention/treatment Phase
Pneumocystis Pneumonia Drug: caspofungin Drug: corticosteroids Drug: Sulfanilamides Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : December 2017


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 Name: 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 Name: methylprednisolone

Drug: Sulfanilamides
1.92g q8h

Active Comparator: no corticosteroids and no caspofungin
patients treat with sulfanilamide only
Drug: Sulfanilamides
1.92g q8h




Primary Outcome Measures :
  1. mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Time for release of fever [ Time Frame: 2 days ]
    Time for body temperature less than 37.3℃ for 48 hours

  2. Time for release of respiratory distress [ Time Frame: 2 days ]
    Time for respiratory rate <25 breathes per minute for 48 hours



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603575


Contacts
Layout table for location contacts
Contact: Hangyong He, MM 861013693585722 yonghang2004@sina.com

Locations
Layout table for location information
China
Beijing Chao Yang Hospital Recruiting
Beijing, China, 100020
Contact: Hangyong He, MM    861085231543    cyh_birm@sina.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital

Layout table for additonal information
Responsible Party: Hangyong He, Doctor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02603575     History of Changes
Other Study ID Numbers: BeijingCYHRICU01
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by Hangyong He, Beijing Chao Yang Hospital:
Caspofungin
corticosteroids
Pneumocystis Pneumonia
Immunocompromised
Non-HIV
respiratory failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Fungal
Caspofungin
Pneumonia, Pneumocystis
Pneumonia
Respiratory Tract Diseases
Respiratory Tract Infections
Mycoses
Pneumocystis Infections
Sulfanilamide
Sulfanilamides
Methylprednisolone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents