How Long Should we Give Steroids for Patients With Severe PCP

NCT07328984 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: 2026-12265527077
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

Brief Summary

The HOW LONG trial is an international, multicenter, Phase IV randomized clinical trial evaluating the optimal duration of adjunctive systemic corticosteroids in immunocompromised adults with severe Pneumocystis jirovecii pneumonia (PCP) who demonstrate early clinical recovery. Participants who no longer require supplemental oxygen by day 10 of corticosteroid therapy are randomized to discontinue corticosteroids at day 10 (or hospital discharge, if earlier) versus continue corticosteroids for a total of 21 days. The trial assesses whether earlier discontinuation reduces steroid-related complications while maintaining clinical outcomes.

Conditions

Pneumocystis Pneumonia; Pneumocystis; Pneumocystis Jirovecii Infection; Pneumocystis Jiroveci Pneumonia; Pneumocystis Carinii; Infection, Resulting From HIV Disease; Pneumocystosis Associated With AIDS; Pneumocystosis; Pneumonia (Etiology)

Keywords

PCP; Systemic Corticosteroids; De-escalation of Therapy; Randomized Control Trial; Immunocompromised host; HIV; Non-HIV; Pneumocystis jirovecii pneumonia

Outcome Measures

Primary Outcomes (1)

• Hierarchical composite clinical outcome

  The primary outcome at day 60 will be the hierarchical composite of: 1. death, 2. relapse of PCP-related hypoxemia (e.g., not due to another obviously identified cause like pulmonary embolism, aspiration event, etc.) requiring more than 12 hours of use of ≥2L of oxygen in accordance with guidelines 3. The development of secondary infections requiring systemic antibiotic therapy 4. The development of severe diabetic complications (ketoacidosis, hyperosmolar coma, new initiation of insulin which is continued at discharge) 5. The development of severe GI bleeding (e.g., necessitating unplanned transfusion and/or endoscopy) and; 6. inpatient length of stay (censored at day 60; deaths assigned 60 days).

  Day 60

Secondary Outcomes (6)

• Death

  Day 60

• relapse of PCP-related hypoxemia

  Day 60

• Secondary infections requiring systemic antibiotic therapy

  Day 60

• The development of severe diabetic complications

  Day 60

• The development of severe GI bleeding (

  Day 60

Other Outcomes (4)

• Quality of life (EQ-5D-5L)

  Day 30

• Quality of life (EQ-5D-5L)

  Day 180

• All-cause mortality

  Day 180

Study Arms (2)

Shortened-Duration Corticosteroids

EXPERIMENTAL

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).

Drug: Systemic corticosteroids

Standard duration of Corticosteroids

ACTIVE COMPARATOR

Continue adjunctive systemic corticosteroids to a total of 21 days (standard of care).

Drug: Systemic corticosteroids

Interventions

Systemic corticosteroids DRUG

Adjunctive systemiccorticosteroid therapy administered as part of standard treatment for pneumocystis Pneumonia, with duration varying by study arm.

Shortened-Duration Corticosteroids; Standard duration of Corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Proven or probable Pneumocystis jirovecii pneumonia
• Severe PCP requiring supplemental oxygen (e.g., ≥4 L/min or ≥35% FiO₂ to maintain SpO₂ ≥94%)
• Planned or receiving adjunctive systemic corticosteroid therapy for severe PCP
• Clinical recovery by day 10 of steroid therapy: breathing room air for ≥6 hours
• Able to provide informed consent (or per local requirements)

You may not qualify if:

• Persistent hypoxemia or ongoing oxygen requirement at day 10
• Clinical deterioration prior to randomization
• Treating clinician determines steroids must be continued or stopped immediately for medical reasons
• Anticipated death within 48 hours
• Inability or unwillingness to complete follow-up through day 180

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill university Health Centre (Royal victoria Hospital and Montreal General Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (2)

• Senecal J, Smyth E, Del Corpo O, Hsu JM, Amar-Zifkin A, Bergeron A, Cheng MP, Butler-Laporte G, McDonald EG, Lee TC. Non-invasive diagnosis of Pneumocystis jirovecii pneumonia: a systematic review and meta-analysis. Clin Microbiol Infect. 2022 Jan;28(1):23-30. doi: 10.1016/j.cmi.2021.08.017. Epub 2021 Aug 28.

  PMID: 34464734 BACKGROUND

• McDonald EG, Butler-Laporte G, Del Corpo O, Hsu JM, Lawandi A, Senecal J, Sohani ZN, Cheng MP, Lee TC. On the Treatment of Pneumocystis jirovecii Pneumonia: Current Practice Based on Outdated Evidence. Open Forum Infect Dis. 2021 Oct 29;8(12):ofab545. doi: 10.1093/ofid/ofab545. eCollection 2021 Dec.

  PMID: 34988242 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; Pneumocystis Infections; Infections; Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Babykumari Chitramuthu, PhD

CONTACT

15149341934; babykumari.chitramuthu@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of medicine

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 9, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year following main publication for a period of 2 years
• Access Criteria: investigators wishing to pursue secondary questions related to the data can contact emily.mcdonald@mcgill.ca for access to the data via a data sharing agreement.

Locations

CA (1)