Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP
- Conditions
- Pneumocystis Pneumonia
- Interventions
- Registration Number
- NCT03978559
- Lead Sponsor
- Bin Du
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 122
- 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
- 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 )
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAS with TMP/SMZ TMP/SMZ(trimethoprim/sulfisoxazole) - TMP/SMZ TMP/SMZ(trimethoprim/sulfisoxazole) - CAS with TMP/SMZ caspofungin - CAS with TMP/SMZ Methylprednisolone - TMP/SMZ Methylprednisolone -
- Primary Outcome Measures
Name Time Method mortality to day 28 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
- Secondary Outcome Measures
Name Time Method ICU Free Days to day 28 28 days after randomization 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)
ICU mortality through ICU discharge, an average of 14 days The percentage of death subjects at ICU discharge
hospital mortality through hospital discharge, an average of 28 days The percentage of death subjects at hospital discharge
SOFA day3, 7, 21 after randomization respiratory dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score for respiratory system
BALF cytokines level on day3, 7, 21 day3, 7, 21 after randomization the change of cytokines in bronchoalveolar lavage fluid (BALF) level between baseline and day7, day21
adverse events till 21 days after randomization incidence, duration and severity of adverse events
serious adverse events till 21 days after randomization incidence, duration and severity of serious adverse events
Mean Ventilator Free Days to day 28 28 days after randomization 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.
PO2/FiO2 on day 7, 21 day 7, 21 after randomization the change of PO2/FiO2 between baseline and day7, 21
serum (1,3)-β-D gluca level on day 3, 7, 21 day3, 7, 21 after randomization the change of (1,3)-β-D glucan level between baseline and day3, 7, 21
PCP-DNA negative conversion rate in alveolar lavage fluid on day 7 after randomization day 7 after randomization the percentage of PCP-DNA negative after 7days treatment
Trial Locations
- Locations (1)
MICU of Peking Union Medical College
🇨🇳Beijing, China