Caspofungin for Pneumocystis Pneumonia in PLWHIV.
- Conditions
- HIV-1-infectionPneumocystis Pneumonia
- Registration Number
- NCT06691321
- Lead Sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality by group at a 30-day follow up. 30 days Compare the efficacy of caspofungin-based treatment with trimethoprim/sulfamethoxazole on 30-day mortality in hospitalized patients with Pneumocystis jirovecii pneumonia.
- Secondary Outcome Measures
Name Time Method Adverse events. 90 days Determine the incidence of adverse reactions to the different regimens used as treatment for PCP.
Mortality by group at a 90-day follow up. 90 days Compare the efficacy of caspofungin-based treatment with trimethoprim/sulfamethoxazole on 90-day mortality in hospitalized patients with Pneumocystis jirovecii pneumonia.
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 Compare the length of hospital stay between the groups.
Requirement and duration of high-flow nasal cannula. Requirement and duration of high-flow nasal cannula between groups. 90 days Compare the requirement and duration of high-flow nasal cannula between the groups.
Requirement and duration of invasive mechanical ventilation. 90 days Compare the requirement and duration of invasive mechanical ventilation between the groups.
Acute respiratory distress syndrome incidence. 90 days Compare the incidence of acute respiratory distress syndrome during hospitalization.
Trial Locations
- Locations (1)
Center for Research in Infectious Diseases (CIENI)
🇲🇽Mexico City, Tlalpan, Mexico