NCT03978559

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Bin Du · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumocystis Pneumonia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-14
• Primary completion: 2022-06-20
• Completion: 2022-07-08
• First posted: 2019-06-07
• Last updated: 2019-09-12

Locations

1 site across 1 country: China