Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS
Status:
Enrolling by invitation
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Centro de Investigación en. Enfermedades Infecciosas, Mexico