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NCT Number: NCT06691321

Caspofungin for Pneumocystis Pneumonia in PLWHIV.

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Research in Infectious Diseases (CIENI)

Mexico City, Tlalpan, 14080, Mexico

Location status: Recruiting

Location contact

Xavier Flores, MD

CONTACT

[email protected]

(+52 55) 5940 2110

Xavier Flores, MD

CONTACT

[email protected]

(+52 55) 5666 7985 ext. 164

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Mortality by group at a 30-day follow up.

    Time frame: 30 days

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

Secondary outcomes

  1. Mortality by group at a 90-day follow up.

    Time frame: 90 days

    Compare the efficacy of caspofungin-based treatment with trimethoprim/sulfamethoxazole on 90-day mortality in hospitalized patients with Pneumocystis jirovecii pneumonia.

  2. Length of hospital stay per group. Length of hospital stay per group. Length of hospital stay per group. Length of hospital stay per group.

    Time frame: 90 days

    Compare the length of hospital stay between the groups.

  3. Requirement and duration of high-flow nasal cannula. Requirement and duration of high-flow nasal cannula between groups.

    Time frame: 90 days

    Compare the requirement and duration of high-flow nasal cannula between the groups.

  4. Requirement and duration of invasive mechanical ventilation.

    Time frame: 90 days

    Compare the requirement and duration of invasive mechanical ventilation between the groups.

  5. Acute respiratory distress syndrome incidence.

    Time frame: 90 days

    Compare the incidence of acute respiratory distress syndrome during hospitalization.

  6. Adverse events.

    Time frame: 90 days

    Determine the incidence of adverse reactions to the different regimens used as treatment for PCP.

Study contacts

Contact information is provided by the study sponsor or research team.

Xavier Flores, MD

CONTACT

[email protected]

(+52 55) 5940 2110

Xavier Flores, MD

CONTACT

[email protected]

(+52 55) 5666 7985 ext. 164

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Enfermedades Respiratorias

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2024
Registry last updated
Nov 19, 2024

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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