Clindamycin-trimethoprim/Sulfamethoxazole for PCP After Solid Organ Transplantation Population.

Completed

• Conditions: Pneumocystis Jirovecii Pneumonia; Solid Organ Transplantation

• Registration Number: NCT04328688
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

PCP is one of the common opportunistic infections in patients with HIV and non-HIV-associated immunodeficiency.With the increasing number of solid organ transplantation, how to effectively treat severe PCP after solid organ transplantation has become an urgent problem to be solved.In general, Atovaquone, Dapsone, and Clindamycin-primaquine can be used as second-line alternatives when TMP-SMX fails to treat HIV-PCP. Therefore, the objective of this study is to preliminarily investigate the safety and efficacy of low-dose TMP-SMX combined with clindamycin (CT regimen) for the treatment of severe PCP after solid organ transplantation.

Detailed Description

PCP is one of the common opportunistic infections in patients with HIV and non-HIV-associated immunodeficiency.With the increasing number of solid organ transplantation, how to effectively treat severe PCP after solid organ transplantation has become an urgent problem to be solved.In general, Atovaquone, Dapsone, and Clindamycin-primaquine can be used as second-line alternatives when TMP-SMX fails to treat HIV-PCP. More and more studies suggest that clindamycin-based alternatives play an increasingly important role in treating of PCP. Therefore, the objective of this study is to preliminarily investigate the safety and efficacy of low-dose TMP-SMX combined with clindamycin (CT regimen) for the treatment of severe PCP after solid organ transplantation.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-30
• Study First Submitted: 2020-01-02
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-28
• Last Update Submitted: 2020-03-28
• Study First Posted: 2020-03-31
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• PJP after solid organ transplantation.

Exclusion Criteria

• renal failure,heart failure,tumor recurrence

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oxygenation index	through study completion, an average of 20 days	PaO2/FiO2
length of ICU stay	through study completion, an average of 20 days	Total length of stay in ICU

Secondary Outcome Measures

Name	Time	Method
adverse reactions of drugs	through study completion, an average of 20 days	Rash，Anorexia，Decreased white blood cell count，Anemia，Decreased platelet count，Increased TB，Increased creatinine，Hyperkalemia

Trial Locations

Locations (1)

Ju Minjie; 🇨🇳 Shanghai, Shanghai, China