Caspofungin for Pneumocystis Pneumonia in PLWHIV. (NCT06691321) | Clinical Trial Compass
RecruitingNot Applicable
Caspofungin for Pneumocystis Pneumonia in PLWHIV.
Mexico60 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing caspofungin for treating Pneumocystis pneumonia — what is it being compared against, and how does my current treatment plan stack up against what's being tested here?
2Since this trial is listed as Phase NA and is measuring 30-day mortality as its main outcome, what does that tell you about how much safety and effectiveness data already exists for using caspofungin specifically for Pneumocystis pneumonia in people living with HIV?
3Would enrolling in this trial mean I might not receive the current standard-of-care treatment for Pneumocystis pneumonia, and could that affect my immediate health given how serious this infection can be?
4Given that this study is actively recruiting and tracking survival at 30 days, how confident are you that joining this trial wouldn't delay or interrupt the HIV and pneumonia treatments I need to start right away?
5Are there aspects of my specific HIV status, CD4 count, or overall health that would make standard treatment a safer or more appropriate path for me right now compared to participating in this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality by group at a 30-day follow up.
Timeframe: 30 days
Trial details
NCT IDNCT06691321
SponsorInstituto Nacional de Enfermedades Respiratorias