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

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.

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

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)

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.

respiratory dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score for respiratory system

the change of cytokines in bronchoalveolar lavage fluid (BALF) level between baseline and day7, day21

Inclusion Criteria: 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 Exclusion Criteria: 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 )