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

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.

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Key information

Conditions

Pneumocystis Jirovecii Pneumonia Bacterial Infections and Mycoses Infections Lung Diseases Lung Diseases, Fungal Mycoses Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis Respiratory Tract Diseases Respiratory Tract Infections Solid Organ Transplantation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ju Minjie

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

PJP after solid organ transplantation.

Exclusion criteria

renal failure,heart failure,tumor recurrence

Treatment and study plan

Primary outcomes

oxygenation index

Time frame: through study completion, an average of 20 days

PaO2/FiO2
length of ICU stay

Time frame: through study completion, an average of 20 days

Total length of stay in ICU

Secondary outcomes

adverse reactions of drugs

Time frame: through study completion, an average of 20 days

Rash，Anorexia，Decreased white blood cell count，Anemia，Decreased platelet count，Increased TB，Increased creatinine，Hyperkalemia

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Mar 31, 2020
Registry last updated: Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed