Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAS with TMP/SMZ | Experimental |
| |
| TMP/SMZ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caspofungin | Drug | caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 28 days after randomization |
| Mean Ventilator Free Days to day 28 |
Not provided
Inclusion Criteria:
3) Not receiving anti-PCP treatment or anti-PCP treatment < 48 hours
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Du | Contact | 0086-10-69155036 | dubin98@gmail.com | |
| JINMIN PENG | Contact | 0086-10-69154040 | pjm731@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MICU of Peking Union Medical College | Recruiting | Beijing | 100730 | China |
Not provided
| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| D013444 | Sulfisoxazole |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TMP/SMZ(trimethoprim/sulfisoxazole) | Drug | TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days |
|
| Methylprednisolone | Drug | 40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days |
|
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.
| 28 days after randomization |
| ICU mortality | The percentage of death subjects at ICU discharge | through ICU discharge, an average of 14 days |
| hospital mortality | The percentage of death subjects at hospital discharge | through hospital discharge, an average of 28 days |
| PO2/FiO2 on day 7, 21 | the change of PO2/FiO2 between baseline and day7, 21 | 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 | 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 | day 7 after randomization |
| SOFA | respiratory dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score for respiratory system | 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 | day3, 7, 21 after randomization |
| adverse events | incidence, duration and severity of adverse events | till 21 days after randomization |
| serious adverse events | incidence, duration and severity of serious adverse events | till 21 days after randomization |
| D016720 |
| Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |