Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP

• Sponsor: Bin Du (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03978559
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.8
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumocystis Pneumonia	Drug: caspofungin; Drug: TMP/SMZ(trimethoprim/sulfisoxazole); Drug: Methylprednisolone	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Aug 14, 2019
• Anticipated Primary Completion Date: Jun 20, 2022
• Anticipated Study Completion Date: Jul 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAS with TMP/SMZ	Drug: caspofungin; caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days; Drug: TMP/SMZ(trimethoprim/sulfisoxazole); TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days; Drug: Methylprednisolone; 40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days
Active Comparator: TMP/SMZ	Drug: TMP/SMZ(trimethoprim/sulfisoxazole); TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days; Drug: Methylprednisolone; 40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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.

3. ICU mortality [through ICU discharge, an average of 14 days]

   The percentage of death subjects at ICU discharge

4. hospital mortality [through hospital discharge, an average of 28 days]

   The percentage of death subjects at hospital discharge

5. PO2/FiO2 on day 7, 21 [day 7, 21 after randomization]

   the change of PO2/FiO2 between baseline and day7, 21

6. 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

7. 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

8. SOFA [day3, 7, 21 after randomization]

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

9. 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

10. adverse events [till 21 days after randomization]

    incidence, duration and severity of adverse events

11. serious adverse events [till 21 days after randomization]

    incidence, duration and severity of serious adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥ 18 years old

2. Non-HIV immunosuppressed patients admitted to the ICU

3. confirmed or suspect PCP

1. 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 )

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MICU of Peking Union Medical College	Beijing		China	100730

Sponsors and Collaborators

• Bin Du

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bin Du, Director, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03978559
• Other Study ID Numbers: MICU-PCP
• First Posted: Jun 7, 2019
• Last Update Posted: Sep 12, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Pneumocystis; Trimethoprim; Caspofungin; Sulfisoxazole; Methylprednisolone

Study Results

No Results Posted as of Sep 12, 2019