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Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record status
This record was last updated March 27, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Oct 30, 2024 to Aug 30, 2026
    • Study completion date: Oct 30, 2025 to Jul 30, 2027
    • Site details revised
    v8
  2. Notable Primary completion date: Dec 4, 2023 to Oct 30, 2024
    • Study completion date: Dec 2024 to Oct 30, 2025
    v7
  3. Notable Primary completion date: Dec 4, 2022 to Dec 4, 2023
    • Study completion date: Feb 2023 to Dec 2024
    v6
  4. Notable Primary completion date: Dec 4, 2021 to Dec 4, 2022
    • Study completion date: Feb 2022 to Feb 2023
    v5
  5. Minor Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  2. Minor Study title shortened, about 2 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03856229
Lead Sponsor Centro de Investigación en. Enfermedades Infecciosas, Mexico
Conditions
(from sponsor)
Pneumocystis, HIV/AIDS, Steroid
Related terms Acquired Immunodeficiency Syndrome, Pneumonia, Pneumocystis
Enrollment 196 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov