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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
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
MICU of Peking Union Medical College
Beijing, China
RECRUITINGmortality 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
Time frame: 28 days after randomization
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)
Time frame: 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.
Time frame: 28 days after randomization
ICU mortality
The percentage of death subjects at ICU discharge
Time frame: through ICU discharge, an average of 14 days
hospital mortality
The percentage of death subjects at hospital discharge
Time frame: through hospital discharge, an average of 28 days
PO2/FiO2 on day 7, 21
the change of PO2/FiO2 between baseline and day7, 21
Time frame: 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
Time frame: 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
Time frame: day 7 after randomization
SOFA
respiratory dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score for respiratory system
Time frame: 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
Time frame: day3, 7, 21 after randomization
adverse events
incidence, duration and severity of adverse events
Time frame: till 21 days after randomization
serious adverse events
incidence, duration and severity of serious adverse events
Time frame: till 21 days after randomization
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