Pneumocystis PneumoniaPhase 4NCT03978559
Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP
A Phase 4 study testing caspofungin, TMP/SMZ(trimethoprim/sulfisoxazole) and Methylprednisolone in people with Pneumocystis Pneumonia, run by Bin Du at 1 site in China.
Trial summary
This is a prospective, randomized clinical trial. During the study, non-HIV patients who are admitted to ICU due to Pneumocystic pneumonia (PCP) and have not received anti-PCP therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumocystis Pneumonia
- What is being tested?
- caspofungin, TMP/SMZ(trimethoprim/sulfisoxazole) and Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2019to 8 Jul 2022
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Non-HIV immunosuppressed patients admitted to the ICU
- confirmed or suspect PCP
- 3) Not receiving anti-PCP treatment or anti-PCP treatment < 48 hours
Who cannot join
- Age less than 18 years old
- Known pregnancy
- allergy to TMP/SMZ or caspofungin
- Decision to withhold life-sustaining treatment
- Patients with advanced pulmonary fibrosis
- severe liver dysfunction(Child-Pugh C )
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
MICU of Peking Union Medical College
Beijing, 100730
Bin Du, Dr, (8610)69155036, dubin98@gmail.com
About this study
Official title: A Prospective Randomized Controlled Study to Compare Efficacy of Caspofungin Combined With Trimethoprim-sulfamethoxazole Versus Trimethoprim/Sulfamethoxazole as First-line Therapy in Non-HIV Patients With Severe Pneumocystis Pneumonia
This is a prospective, randomized clinical trial. During the study, non-HIV patients who are admitted to ICU due to Pneumocystic pneumonia (PCP) and have not received anti-PCP therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole or trimethoprim-sulfamethoxazole alone.
The aim of this study is to compare the effectiveness of caspofungin combined with trimethoprim-sulfamethoxazole with that of conventional therapy (trimethoprim-sulfamethoxazole alone) as first-line therapy in the treatment of severe Pneumocystis pneumonia (PCP) in non-HIV patients.
- Conditions
- Pneumocystis Pneumonia
- Being tested
- caspofungin, TMP/SMZ(trimethoprim/sulfisoxazole), Methylprednisolone
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofunginDrug
caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days
TMP/SMZ(trimethoprim/sulfisoxazole)Drug
TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days
40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days
| Study group | Role | What they receive |
|---|---|---|
| CAS with TMP/SMZ | Experimental | Not described Receives: Drug: caspofungin; Drug: TMP/SMZ(trimethoprim/sulfisoxazole); Drug: Methylprednisolone |
| TMP/SMZ | Active comparator | Not described Receives: Drug: TMP/SMZ(trimethoprim/sulfisoxazole); Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality to day 28
The percentage of subjects death at study day 28. Those subjects discharged from ICU prior to day 28 were counted as alive at day 28
Measured: 28 days after randomization
Secondary outcomes (11)
ICU Free Days to day 28
defined as the number of days between randomization and day 28 in which the patient is not in the ICU (for any part of a day)
Measured: 28 days after randomization
Mean Ventilator Free Days to day 28
Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.
Measured: 28 days after randomization
ICU mortality
The percentage of death subjects at ICU discharge
Measured: through ICU discharge, an average of 14 days
hospital mortality
The percentage of death subjects at hospital discharge
Measured: through hospital discharge, an average of 28 days
PO2/FiO2 on day 7, 21
the change of PO2/FiO2 between baseline and day7, 21
Measured: day 7, 21 after randomization
serum (1,3)-β-D gluca level on day 3, 7, 21
the change of (1,3)-β-D glucan level between baseline and day3, 7, 21
Measured: day3, 7, 21 after randomization
PCP-DNA negative conversion rate in alveolar lavage fluid on day 7 after randomization
the percentage of PCP-DNA negative after 7days treatment
Measured: day 7 after randomization
SOFA
respiratory dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score for respiratory system
Measured: day3, 7, 21 after randomization
BALF cytokines level on day3, 7, 21
the change of cytokines in bronchoalveolar lavage fluid (BALF) level between baseline and day7, day21
Measured: day3, 7, 21 after randomization
adverse events
incidence, duration and severity of adverse events
Measured: till 21 days after randomization
serious adverse events
incidence, duration and severity of serious adverse events
Measured: till 21 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start14 Aug 2019
- Primary completion20 Jun 2022 (estimated)
- Study completion8 Jul 2022 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Du
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Du, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978559
- Sponsor's protocol ID
- MICU-PCP
- Status last verified
- Sep 2019
- First submitted
- 5 Jun 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study to Compare Efficacy of Caspofungin Combined With Trimethoprim-sulfamethoxazole Versus Trimethoprim/Sulfamethoxazole as First-line Therapy in Non-HIV Patients With Severe Pneumocystis Pneumonia
- ClinicalTrials.gov ID
- NCT03978559
- Acronym / sponsor ID
- MICU-PCP
- Conditions
- Pneumocystis Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Bin DuUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 8 Jul 2022 (estimated)
- First posted
- 7 Jun 2019 (actual)
- 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.
This is a prospective, randomized clinical trial. During the study, non-HIV patients who are admitted to ICU due to Pneumocystic pneumonia (PCP) and have not received anti-PCP therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole or trimethoprim-sulfamethoxazole alone.
The aim of this study is to compare the effectiveness of caspofungin combined with trimethoprim-sulfamethoxazole with that of conventional therapy (trimethoprim-sulfamethoxazole alone) as first-line therapy in the treatment of severe Pneumocystis pneumonia (PCP) in non-HIV patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAS with TMP/SMZ | Experimental | Drug: caspofungin, Drug: TMP/SMZ(trimethoprim/sulfisoxazole), Drug: Methylprednisolone |
| TMP/SMZ | Active comparator | Drug: TMP/SMZ(trimethoprim/sulfisoxazole), Drug: Methylprednisolone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Non-HIV immunosuppressed patients admitted to the ICU
- confirmed or suspect PCP
- 3) Not receiving anti-PCP treatment or anti-PCP treatment < 48 hours
Key exclusion criteria (6 listed)
- Age less than 18 years old
- Known pregnancy
- allergy to TMP/SMZ or caspofungin
- Decision to withhold life-sustaining treatment
- Patients with advanced pulmonary fibrosis
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 |
|---|---|---|
| caspofungincaspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days | Drug | CAS with TMP/SMZ |
| TMP/SMZ(trimethoprim/sulfisoxazole)TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days | Drug | CAS with TMP/SMZ, TMP/SMZ |
| Methylprednisolone40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days | Drug | CAS with TMP/SMZ, TMP/SMZ |
Primary outcome
mortality to day 28
Time frame: 28 days after randomization
The percentage of subjects death at study day 28. Those subjects discharged from ICU prior to day 28 were counted as alive at day 28
11 secondary outcomes
ICU Free Days to day 28
Time frame: 28 days after randomization
Mean Ventilator Free Days to day 28
Time frame: 28 days after randomization
ICU mortality
Time frame: through ICU discharge, an average of 14 days
hospital mortality
Time frame: through hospital discharge, an average of 28 days
PO2/FiO2 on day 7, 21
Time frame: day 7, 21 after randomization
serum (1,3)-β-D gluca level on day 3, 7, 21
Time frame: day3, 7, 21 after randomization
PCP-DNA negative conversion rate in alveolar lavage fluid on day 7 after randomization
Time frame: day 7 after randomization
SOFA
Time frame: day3, 7, 21 after randomization
BALF cytokines level on day3, 7, 21
Time frame: day3, 7, 21 after randomization
adverse events
Time frame: till 21 days after randomization
serious adverse events
Time frame: till 21 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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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 Phase 4 study testing caspofungin, TMP/SMZ(trimethoprim/sulfisoxazole) and Methylprednisolone in people with Pneumocystis Pneumonia, run by Bin Du 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 4 inclusion and 6 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 12 Sep 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bin Du (0086-10-69155036, dubin98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality to day 28 (time frame: 28 days after randomization). 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 12 Sep 2019.