Pneumocystis Pneumonia
Conditions
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.
Interventions
DRUGcaspofungin
caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days
DRUGTMP/SMZ(trimethoprim/sulfisoxazole)
TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days
DRUGMethylprednisolone
40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days
Sponsors
Bin Du
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 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
1. Age less than 18 years old 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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactBin Du
Backup ContactJINMIN PENG
Outcome results
None listed