Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP
NCT ID: NCT03978559
Last Updated: 2019-09-12
Study Results
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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UNKNOWN
PHASE4
122 participants
INTERVENTIONAL
2019-08-14
2022-07-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CAS with TMP/SMZ
caspofungin
caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days
TMP/SMZ(trimethoprim/sulfisoxazole)
TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days
Methylprednisolone
40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days
TMP/SMZ
TMP/SMZ(trimethoprim/sulfisoxazole)
TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days
Methylprednisolone
40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days
Interventions
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caspofungin
caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days
TMP/SMZ(trimethoprim/sulfisoxazole)
TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days
Methylprednisolone
40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days
Eligibility Criteria
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Inclusion Criteria
2. Non-HIV immunosuppressed patients admitted to the ICU
3. confirmed or suspect PCP
3\) Not receiving anti-PCP treatment or anti-PCP treatment \< 48 hours
Exclusion Criteria
2. Known pregnancy
3. allergy to TMP/SMZ or caspofungin
4. Decision to withhold life-sustaining treatment
5. Patients with advanced pulmonary fibrosis
6. severe liver dysfunction(Child-Pugh C )
18 Years
80 Years
ALL
No
Sponsors
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Bin Du
OTHER
Responsible Party
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Bin Du
Director
Locations
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MICU of Peking Union Medical College
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MICU-PCP
Identifier Type: -
Identifier Source: org_study_id
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