Pneumocystis PneumoniaNCT02603575
Effects and Safety of Caspofungin and Corticosteroids in Pneumocystis Pneumonia in Non-HIV Patients
A study testing caspofungin, corticosteroids and Sulfanilamides in people with Pneumocystis Pneumonia, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pneumocystis Pneumonia
- What is being tested?
- caspofungin, corticosteroids and Sulfanilamides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Immunocompromised Non-HIV Infected Patients
- Partial arterial O2 pressure(PaO2)/FiO2≤300mmHg
- Diagnosed as Pneumocystis Pneumonia
Who cannot join
- younger than 16 years old
- severe organ failure
- allergic to sulfanilamide, caspofungin or corticosteroid
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chao Yang Hospital
Beijing, 100020
Hangyong He, MM, 861085231543, cyh_birm@sina.com
About this study
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℃.
- Conditions
- Pneumocystis Pneumonia
- Being tested
- caspofungin, corticosteroids, Sulfanilamides
- Keywords
- Caspofungin, corticosteroids, Pneumocystis Pneumonia, Immunocompromised, Non-HIV, respiratory failure
- Medical subject headings
- Pneumonia, Pneumocystis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofunginDrug
70mg ivdrip the first day, then 50mg ivdrip qd
corticosteroidsDrug
Also called methylprednisolone
40mg ivdrip q12h for 5 days 40mg ivdrip qd for 5 days 20mg po for 11 days
SulfanilamidesDrug
1.92g q8h
| Study group | Role | What they receive |
|---|---|---|
| Caspofungin and corticosteroids | Experimental | patients treat with caspofungin and corticosteroids on the base of sulfanilamide Receives: Drug: caspofungin; Drug: corticosteroids; Drug: Sulfanilamides |
| Caspofungin and no corticosteroids | Active comparator | patients treat with caspofungin on the base of sulfanilamide Receives: Drug: caspofungin; Drug: Sulfanilamides |
| corticosteroids and no caspofungin | Active comparator | patients treat with corticosteroids on the base of sulfanilamide Receives: Drug: corticosteroids; Drug: Sulfanilamides |
| no corticosteroids and no caspofungin | Active comparator | patients treat with sulfanilamide only Receives: Drug: Sulfanilamides |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 28 days
Secondary outcomes (2)
Time for release of fever
Time for body temperature less than 37.3℃ for 48 hours
Measured: 2 days
Time for release of respiratory distress
Time for respiratory rate <25 breathes per minute for 48 hours
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumocystis PneumoniaStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hangyong He, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603575
- Sponsor's protocol ID
- BeijingCYHRICU01
- Status last verified
- Jan 2020
- First submitted
- 8 Nov 2015
- Last updated
- 13 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Safety of Caspofungin and Corticosteroids in Pneumocystis Pneumonia in Non-HIV Patients
- ClinicalTrials.gov ID
- NCT02603575
- Acronym / sponsor ID
- BeijingCYHRICU01
- Conditions
- Pneumocystis Pneumonia
- Keywords
- Caspofungin, corticosteroids, Pneumocystis Pneumonia, Immunocompromised, Non-HIV, respiratory failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2020 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caspofungin and corticosteroids | Experimental | Drug: caspofungin, Drug: corticosteroids, Drug: Sulfanilamidespatients treat with caspofungin and corticosteroids on the base of sulfanilamide |
| Caspofungin and no corticosteroids | Active comparator | Drug: caspofungin, Drug: Sulfanilamidespatients treat with caspofungin on the base of sulfanilamide |
| corticosteroids and no caspofungin | Active comparator | Drug: corticosteroids, Drug: Sulfanilamidespatients treat with corticosteroids on the base of sulfanilamide |
| no corticosteroids and no caspofungin | Active comparator | Drug: Sulfanilamidespatients treat with sulfanilamide only |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Immunocompromised Non-HIV Infected Patients
- Partial arterial O2 pressure(PaO2)/FiO2≤300mmHg
- Diagnosed as Pneumocystis Pneumonia
Key exclusion criteria (3 listed)
- younger than 16 years old
- severe organ failure
- allergic to sulfanilamide, caspofungin or corticosteroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caspofungin70mg ivdrip the first day, then 50mg ivdrip qd | Drug | Caspofungin and corticosteroids, Caspofungin and no corticosteroids |
| corticosteroidsAlso: methylprednisolone40mg ivdrip q12h for 5 days 40mg ivdrip qd for 5 days 20mg po for 11 days | Drug | Caspofungin and corticosteroids, corticosteroids and no caspofungin |
| Sulfanilamides1.92g q8h | Drug | Caspofungin and corticosteroids, Caspofungin and no corticosteroids, corticosteroids and no caspofungin, no corticosteroids and no caspofungin |
Primary outcome
mortality
Time frame: 28 days
2 secondary outcomes
Time for release of fever
Time frame: 2 days
Time for release of respiratory distress
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caspofungin, corticosteroids and Sulfanilamides in people with Pneumocystis Pneumonia, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hangyong He, MM (861013693585722, yonghang2004@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.