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临床试验/NCT06691321
NCT06691321招募中不适用

Efficacy of Caspofungin for Pneumocystis Jirovecii Pneumonia in People Living With HIV/AIDS.

Instituto Nacional de Enfermedades Respiratorias1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Mortality by group at a 30-day follow up.

研究概览

简要总结

Pneumocystis jirovecii pneumonia is a significant concern in peaple with HIV/AIDS, often severe and potentially fatal. While trimethoprim/sulfamethoxazole remains the primary treatment, safety concerns exist with alternative options. Research on Pneumocystis jirovecii's beta-D glucan composition has prompted investigations into echinocandins like caspofungin, showing promise in murine models and some positive results in human studies. Evaluating caspofungin's efficacy through observational studies is crucial due to safety advantages over current treatments and limited documented data.

详细描述

Pneumocystis jirovecii pneumonia (PCP) is a significant opportunistic disease in immunocompromised patients with HIV/AIDS, becoming increasingly prevalent. This condition can range in severity, at times being fatal and necessitating drastic measures. The standard first-line treatment, trimethoprim/sulfamethoxazole, has been unchanged for over three decades. While other drugs have been approved as second-line treatments, they come with safety concerns such as increased risk of hypersensitivity reactions and adverse effects.

Research on Pneumocystis jirovecii has faced challenges due to difficulties in cultivation, requiring in vivo models for study. Previous studies have found that the wall of Pneumocystis spp. contains beta-D glucans in one phase of its life cycle. This discovery has led to investigations into the effectiveness of echinocandins, specifically caspofungin, on Pneumocystis spp. Promising results have been observed in murine models; however, these studies were conducted on species that do not affect humans. Clinical observational studies in humans have shown positive response and safety, albeit using caspofungin in combination with other drugs rather than as monotherapy.

Considering the superior safety profile of echinocandins compared to first-line treatments for P. jirovecii, and the limited documented data in case reports or series, it is important to assess the efficacy of caspofungin in observational studies to address this gap.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of probable or proven PCP, according to its diagnostic classification (refer to classification at the end of this section).
  • Have clinical laboratory and virological diagnostic laboratory studies at the time of admission.
  • Classification criteria for Pneumonia by P. jirovecii according to Robert-Gangneux et al.:
  • Proven: Confirmation by pathology or microbiology. Possible: Presence of three out of four clinical or radiological criteria. Probable: Presence of one clinical or radiological criterion without another identified microorganism.

排除标准

  • With a treatment switch to caspofungin after day 7 of treatment initiation (applies only to group B).
  • Patients who have developed an additional opportunistic lung infection during their hospitalization, other than cytomegalovirus pneumonitis or SARS-CoV-2 pneumonia.

结局指标

主要结局

Mortality by group at a 30-day follow up.

时间窗: 30 days

Compare the efficacy of caspofungin-based treatment with trimethoprim/sulfamethoxazole on 30-day mortality in hospitalized patients with Pneumocystis jirovecii pneumonia.

次要结局

  • Mortality by group at a 90-day follow up.(90 days)
  • Length of hospital stay per group. Length of hospital stay per group. Length of hospital stay per group. Length of hospital stay per group.(90 days)
  • Requirement and duration of high-flow nasal cannula. Requirement and duration of high-flow nasal cannula between groups.(90 days)
  • Requirement and duration of invasive mechanical ventilation.(90 days)
  • Acute respiratory distress syndrome incidence.(90 days)
  • Adverse events.(90 days)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Santiago Avila-Rios

Head of the Center for Research in Infectious Diseases.

Instituto Nacional de Enfermedades Respiratorias

研究点 (1)

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