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

Pneumocystis Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978559
• Other study ID #: MICU-PCP
• Status: Recruiting
• Phase: Phase 4
• Start date: August 14, 2019
• Est. completion date: July 8, 2022

Study information

• Verified date: September 2019
• Source: Peking Union Medical College Hospital
• Contact: Bin Du
• Phone: 0086-10-69155036
• Email: dubin98[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: July 8, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Pneumocystis Pneumonia
• Pneumonia
• Pneumonia, Pneumocystis

Intervention

Drug:
• caspofungin
caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days
• TMP/SMZ(trimethoprim/sulfisoxazole)
TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days
• Methylprednisolone
40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days

Locations

Country	Name	City	State
China	MICU of Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Bin Du

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Mean Ventilator Free Days to day 28	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
Secondary	ICU mortality	The percentage of death subjects at ICU discharge	through ICU discharge, an average of 14 days
Secondary	hospital mortality	The percentage of death subjects at hospital discharge	through hospital discharge, an average of 28 days
Secondary	PO2/FiO2 on day 7, 21	the change of PO2/FiO2 between baseline and day7, 21	day 7, 21 after randomization
Secondary	serum (1,3)-ß-D gluca level on day 3, 7, 21	the change of (1,3)-ß-D glucan level between baseline and day3, 7, 21	day3, 7, 21 after randomization
Secondary	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
Secondary	SOFA	respiratory dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score for respiratory system	day3, 7, 21 after randomization
Secondary	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
Secondary	adverse events	incidence, duration and severity of adverse events	till 21 days after randomization
Secondary	serious adverse events	incidence, duration and severity of serious adverse events	till 21 days after randomization