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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04328688

Enrollment

Registered

2020-03-31

Start date

2017-09-01

Completion date

2019-09-30

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumocystis Jirovecii Pneumonia, Solid Organ Transplantation

Keywords

TMP-SMX, clindamycin, oxygenation index, adverse reactions

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* PJP after solid organ transplantation.

Exclusion criteria

* renal failure,heart failure,tumor recurrence

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results