Caspofungin for Pneumocystis Pneumonia in PLWHIV.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorInstituto Nacional de Enfermedades Respiratorias
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study will be conducted with data extracted from the clinical records of patients with human immunodeficiency virus (HIV), hospitalized for Pneumocystis jirovecii pneumonia (PCP) from January 2015 to December 2023.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: TMP/SMZ (Control)
Group B: Caspo (Study)
Trial outcomes
Primary outcomes
1
Mortality by group at a 30-day follow up.
Compare the efficacy of caspofungin-based treatment with trimethoprim/sulfamethoxazole on 30-day mortality in hospitalized patients with Pneumocystis jirovecii pneumonia.
Time frame
30 daysSecondary outcomes
1
Mortality by group at a 90-day follow up.
Compare the efficacy of caspofungin-based treatment with trimethoprim/sulfamethoxazole on 90-day mortality in hospitalized patients with Pneumocystis jirovecii pneumonia.
Time frame
90 days2
Length of hospital stay per group. Length of hospital stay per group. Length of hospital stay per group. Length of hospital stay per group.
Compare the length of hospital stay between the groups.
Time frame
90 days3
Requirement and duration of high-flow nasal cannula. Requirement and duration of high-flow nasal cannula between groups.
Compare the requirement and duration of high-flow nasal cannula between the groups.
Time frame
90 days4
Requirement and duration of invasive mechanical ventilation.
Compare the requirement and duration of invasive mechanical ventilation between the groups.
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov