Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS (NCT03856229) | Clinical Trial Compass
By InvitationNot Applicable
Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS
Mexico196 participantsStarted 2019-03-04
Plain-language summary
The treatment guidelines for Pneumocystis pneumonia (PCP) suggest adding 40mg of prednisone (or its equivalent in methylprednisolone) twice per day on days 1 through 5, 40 mg days 6 through 10, and 20 mg daily on days 11 through 21 in subjects with moderate and serious PCP. Steroids have shown to improve clinical outcome and reduction in mortality in HIV-infected patients the effectiveness of adjuvant steroid treatment for PCP has been observed if it starts within the first 24 to 48 hours. Possibly, there is a long-term benefit with their use in the recovery of function and limitation of chronic pulmonary complications; recently, benefits have been observed in decreasing the incidence of Inflammatory Immune Reconstitution Syndrome (IRIS) due to Mycobacterium tuberculosis. On the other hand, steroids could increase the morbidity related to adverse reactions as well as paradoxical worsening of associated herpes virus infection, which are attributed to IRIS or as a result of immunosuppression generated by their use. Recently, it has been shown that gradually steroids withdrawal is not necessary in patients who have received less than 21 days of treatment.
This non-inferiority work aims to confirm the null hypothesis that a reduced steroid scheme in patients with moderate PCP (8 days) and severe pneumonia (14 days) is sufficient to limit long-term ventilatory complications and acute postinflammatory syndrome, compared to the conventional 21-day scheme. It also has been hypothesized that it could be associated with fewer cases of IRIS due to herpes virus type 1,2,3 and 8.
Who can participate
Age range
18 Years – 80 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:
* Older than 18 years
* To have a gasometry at the admission that confirms moderate or severe PCP.
* Patients receiving trimethoprim / sulfamethoxazole in doses of 15 to 20 mg / kg per day from the first 24 hours after admission.
* Patients who have begun adjuvant treatment with steroids in the first 48 hours after admission.
* No history of chronic pulmonary disease.
* APACHE at hospitalization less than 20 points.
Exclusion Criteria:
* Allergic to TMP/SMX, who have not tolerated desensitization.
* History of inflammatory, infectious, autoimmune or neoplastic diseases except Kaposi's sarcoma, which merit the chronic use of steroids.
* Pleural or pericardial effusion and meningitis from any cause.
* Septic shock not related to PCP.
* Subjects who during the hospitalization have been diagnosed with any neoplasia (except Kaposi´s sarcoma)
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 specifically studying short-term steroid therapy for Pneumocystis pneumonia in people with HIV/AIDS — does my current situation match what they're looking for, and would steroids even be appropriate given my condition right now?
2The trial is measuring mortality at 30 days as its main outcome — what does that tell us about how serious my case of Pneumocystis pneumonia is, and how does the steroid treatment being studied compare to what I'd receive with standard care?
3Since this trial is 'enrolling by invitation only,' how would I even get considered for it, and is there a reason my care team might or might not refer me?
4The trial is listed as 'Phase NA,' which means it may not follow the typical drug-trial safety testing phases — what does that mean for what's already known about the risks and benefits of this steroid approach?
5If I'm not able to join this trial, are there established guidelines for using short-term steroids in Pneumocystis pneumonia that my team would follow instead, and how would that differ from what's being studied here?
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
Cumulative incidence of Mortality at 30 days
Timeframe: 30 days
Trial details
NCT IDNCT03856229
SponsorCentro de Investigación en. Enfermedades Infecciosas, Mexico