Clinical trial NCT04328688: Clindamycin-trimethoprim/Sulfamethoxazole for PCP After Solid Organ Transplantation Population.
Official title: Clindamycin - Trimethoprim/Sulfamethoxazole for Pneumocystis Jiroveci Pneumonia After Solid Organ Transplantation Population (CTSTOP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumocystis Jirovecii Pneumonia
Solid Organ Transplantation
Keywords: TMP-SMX
clindamycin
oxygenation index
adverse reactions
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A. the clinical manifestations are fever, shortness of breath, dry cough ,respiratory distress B. Chest CT showed manifested by fine, bilateral, perihilar, diffuse infiltrates , an interstitial alveolar butterfly pattern C. Bronchoalveolar lavage was sent for next generation sequencing (NGS)

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.

Eligibility criteria: Inclusion Criteria:

* PJP after solid organ transplantation.

Exclusion Criteria:

* renal failure,heart failure,tumor recurrence

Primary outcomes:
measure: oxygenation index
timeFrame: through study completion, an average of 20 days
measure: length of ICU stay
timeFrame: through study completion, an average of 20 days
Secondary outcomes:
measure: adverse reactions of drugs
timeFrame: through study completion, an average of 20 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ju Minjie
state: Shanghai
Study officials:
References:
citation: Gu ZY, Liu WJ, Huang DL, Liu YJ, He HY, Yang C, Liu YM, Xu M, Rong RM, Zhu DM, Luo Z, Ju MJ. Preliminary Study on the Combination Effect of Clindamycin and Low Dose Trimethoprim-Sulfamethoxazole on Severe Pneumocystis Pneumonia After Renal Transplantation. Front Med (Lausanne). 2022 May 6;9:827850. doi: 10.3389/fmed.2022.827850. eCollection 2022.