Systemic Corticosteroids for Pneumocystis Pneumonia
(HOW LONG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the optimal duration for using corticosteroids (a type of anti-inflammatory medication) to treat severe Pneumocystis pneumonia in individuals with weakened immune systems. It compares stopping the medication after 10 days to the usual 21 days to determine if a shorter treatment reduces side effects without affecting recovery. Suitable participants have experienced severe Pneumocystis pneumonia, require extra oxygen, and have begun to recover enough to breathe unaided for at least six hours by the tenth day of corticosteroid treatment. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It mainly focuses on the use of corticosteroids for treating pneumonia.
What is the safety track record for systemic corticosteroids?
Research shows that systemic corticosteroids can safely treat severe Pneumocystis pneumonia (PCP), especially in individuals with weakened immune systems. Studies have found that these steroids do not increase side effects, such as additional infections, compared to other treatments.
The FDA has already approved systemic corticosteroids for other uses, and their widespread use confirms their safety. Research has demonstrated that these steroids can improve health outcomes in PCP patients, regardless of HIV status, and can even reduce the risk of death in the initial weeks of treatment.
Overall, the safety data for systemic corticosteroids is reassuring. They are generally well-tolerated and have been used successfully in similar situations.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the systemic corticosteroid treatments for Pneumocystis pneumonia because they offer a potentially more efficient way to manage the condition. Unlike the standard treatment, which extends corticosteroid use to a full 21 days, one of the trial approaches tests a shortened duration, stopping at 10 days or upon hospital discharge if recovery is confirmed. This shortened approach could reduce the time patients are on medication, potentially minimizing side effects and hospital stays while still ensuring effective treatment.
What evidence suggests that this trial's treatments could be effective for Pneumocystis pneumonia?
Research shows that corticosteroids can help people with severe Pneumocystis pneumonia (PCP) by reducing the risk of breathing problems and increasing survival chances. In this trial, participants will join different treatment arms to evaluate corticosteroids' effectiveness. One arm will receive a shortened-duration course, stopping systemic corticosteroids at day 10 of therapy or at hospital discharge, whichever comes first, after documented clinical recovery. The other arm will follow the standard 21-day duration of corticosteroids. Previous studies suggest that shorter courses might be as effective as the usual 21-day treatment, with about 60% of patients stopping steroids after 14 days without losing benefits. These findings indicate that corticosteroids are effective for PCP, and shorter courses might still provide strong results.678910
Are You a Good Fit for This Trial?
This trial is for immunocompromised adults with severe Pneumocystis jirovecii pneumonia (PCP) who show improvement by day 10 of steroid treatment. It's not specified who can't join, but typically those with conditions that could interfere with the study or risk their health would be excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adjunctive systemic corticosteroids, randomized to either discontinue at day 10 or continue for 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary outcomes assessed at day 60
Extended Follow-up
Long-term monitoring for quality of life and all-cause mortality through day 180
What Are the Treatments Tested in This Trial?
Interventions
- Systemic corticosteroids
Trial Overview
The trial tests if stopping steroids at day 10 when patients improve is as effective as continuing them for a total of 21 days. It aims to see if this reduces complications from long-term steroid use without affecting recovery from PCP.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Discontinue adjunctive systemic corticosteroids at day 10 of therapy or at hospital discharge (whichever occurs first), after documented clinical recovery (room air for ≥6 hours).
Continue adjunctive systemic corticosteroids to a total of 21 days (standard of care).
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Citations
Adjunctive corticosteroids may be associated with better ...
Our meta-analysis suggests that among non-HIV PCP patients with respiratory failure, CAT use may be associated with better clinical outcomes.
A 21-Day of Adjunctive Corticosteroid Use May Not Be ...
Shorter adjunctive corticosteroid therapy was clinically effective and adjunctive corticosteroid could be discontinued within 14 days in 60% of ...
Adjunctive corticosteroids in non-AIDS patients with severe ...
Adjunctive corticosteroids improve outcomes of P jirovecii pneumonia in HIV-positive patients. The aim of this trial was to assess the effects ...
4.
dovepress.com
dovepress.com/comparative-dosing-of-adjunctive-corticosteroids-therapy-for-pneumocys-peer-reviewed-fulltext-article-IDRComparative Dosing of Adjunctive Corticosteroids Therapy ...
Conclusion: The standard-dose steroid therapy significantly reduced 28-day and 60-day mortality without major complications in the non-HIV ...
Corticosteroids as Adjunctive Therapy for Severe ...
Early adjunctive corticosteroid therapy can improve survival and decrease the occurrence of respiratory failure in patients with AIDS and severe P. carinii ...
Adjunctive corticosteroids in non-AIDS patients with severe ...
There were no significant differences in safety outcomes between groups, especially for all secondary infections (38 [34·2%; 95% CI 25·4 to 43·1] ...
Adjunctive Corticosteroid Use and Clinical Outcomes in ...
Adjunctive corticosteroids improve outcomes in HIV-associated Pneumocystis jirovecii pneumonia (PCP), but their role in non-HIV-associated ...
Effects of adjunctive corticosteroids therapy in Non-HIV ...
During the initial two weeks of PJP treatment, patients receiving corticosteroids showed a trend toward decreased mortality. This early survival ...
9.
clinicalinfo.hiv.gov
clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/pneumocystisPneumocystis Pneumonia: Adult and Adolescent OIs | NIH
The benefits of starting steroids later are unclear, but most clinicians would administer them even after 72 hours for people with HIV who have ...
Pneumocystis jirovecii Pneumonia in HIV-Negative, Non ...
Mortality of PJP among HIV-negative patients is very high. Mortality ranges from 30 to 40%, higher compared to HIV-positive patients. Additional ...
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