Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP
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
1 other identifier
interventional
122
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2019
Typical duration for phase_4
1 active site
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
First Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
August 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2022
CompletedSeptember 12, 2019
September 1, 2019
2.9 years
June 5, 2019
September 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
28 days after randomization
Secondary Outcomes (11)
ICU Free Days to day 28
28 days after randomization
Mean Ventilator Free Days to day 28
28 days after randomization
ICU mortality
through ICU discharge, an average of 14 days
hospital mortality
through hospital discharge, an average of 28 days
PO2/FiO2 on day 7, 21
day 7, 21 after randomization
- +6 more secondary outcomes
Study Arms (2)
CAS with TMP/SMZ
EXPERIMENTALTMP/SMZ
ACTIVE COMPARATORInterventions
caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days
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
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old
- Non-HIV immunosuppressed patients admitted to the ICU
- confirmed or suspect PCP
- \) Not receiving anti-PCP treatment or anti-PCP treatment \< 48 hours
You may not qualify if:
- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bin Dulead
Study Sites (1)
MICU of Peking Union Medical College
Beijing, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 7, 2019
Study Start
August 14, 2019
Primary Completion
June 20, 2022
Study Completion
July 8, 2022
Last Updated
September 12, 2019
Record last verified: 2019-09