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

Solid Organ Transplantation Clinical Trial

Official title:

Clindamycin - Trimethoprim/Sulfamethoxazole for Pneumocystis Jiroveci Pneumonia After Solid Organ Transplantation Population (CTSTOP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328688
• Other study ID #: CTSTOP
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2020
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• PJP after solid organ transplantation.

Exclusion Criteria:

• renal failure,heart failure,tumor recurrence

Related Conditions & MeSH terms

• Pneumocystis Jirovecii Pneumonia
• Pneumonia
• Pneumonia, Pneumocystis
• Solid Organ Transplantation

Locations

Country	Name	City	State
China	Ju Minjie	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation index	PaO2/FiO2	through study completion, an average of 20 days
Primary	length of ICU stay	Total length of stay in ICU	through study completion, an average of 20 days
Secondary	adverse reactions of drugs	Rash,Anorexia,Decreased white blood cell count,Anemia,Decreased platelet count,Increased TB,Increased creatinine,Hyperkalemia	through study completion, an average of 20 days