NCT03856229Enrolling by invitation
Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS
Shortened Steroid Therapy in Patients With Moderate and Severe Pneumonia Due to P. Jirovecii Associated With HIV / AIDS
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 8 Feb 2019
- Start date
- 4 Mar 2019
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Diseases
- HIV
- NCT number
- NCT03856229
What you commit to
- Study type: Interventional
- Planned participants: 196
- From 4 Mar 2019 to the primary completion date, 30 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigacion en Enfermedades Infecciosas Coordinator of this site? Confirm its status | México | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.