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NCT Number: NCT07328984

How Long Should we Give Steroids for Patients With Severe PCP

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.

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Key information

Conditions

Pneumocystis Pneumonia Bacterial Infections and Mycoses Infections Lung Diseases Lung Diseases, Fungal Mycoses Pneumocystis Pneumocystis Carinii; Infection, Resulting From HIV Disease Pneumocystis Infections Pneumocystis Jiroveci Pneumonia Pneumocystis Jirovecii Infection Pneumocystosis Associated With AIDS Pneumocystosis; Pneumonia (Etiology) Pneumonia Pneumonia, Pneumocystis Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Montreal, Quebec, H4A 3J1, Canada

Location contact

Babykumari Chitramuthu, PhD

CONTACT

[email protected]

5149341934 ext. 23730

Emily G McDonald, MD MSc

PRINCIPAL_INVESTIGATOR

Matthew P Cheng, MDCM, FRCPC, FACP, DABMM

PRINCIPAL_INVESTIGATOR

Todd C Lee, MD MPH FIDSA

PRINCIPAL_INVESTIGATOR

About this study

Adjunctive systemic corticosteroids are routinely used in severe PCP to reduce pulmonary inflammation and improve survival, but the recommended 21-day duration is based on limited historical evidence. Prolonged corticosteroid exposure may increase risks including secondary infections, hyperglycemia, gastrointestinal bleeding, and other adverse effects. The HOW LONG trial tests whether stopping corticosteroids earlier, after clinical recovery, improves net clinical outcomes.

Eligible adults with proven or probable severe PCP who have recovered to room air (no need for supplemental oxygen) for at least 6 hours by day 10 of corticosteroid therapy are enrolled and randomized centrally 1:1 in the MUHC Research Electronic Data Capture (REDCap) system to (1) discontinuation of corticosteroids at day 10 or hospital discharge or (2) continuation of corticosteroids to a total of 21 days. All participants receive standard antimicrobial therapy for PCP per treating clinicians. Follow-up occurs to day 180.

The primary endpoint is a hierarchical composite outcome assessed at day 60, incorporating mortality, relapse of PCP-related hypoxemia, secondary infections, severe metabolic or gastrointestinal complications, and length of hospital stay. Secondary endpoints include individual components of the composite outcome, and tertiary endpoints include quality of life and longer-term outcomes through day 180.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Systemic corticosteroids

Drug

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

Primary outcomes

  1. Hierarchical composite clinical outcome

    Time frame: Day 60

    The primary outcome at day 60 will be the hierarchical composite of:

    • death,
    • 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
    • The development of secondary infections requiring systemic antibiotic therapy
    • The development of severe diabetic complications (ketoacidosis, hyperosmolar coma, new initiation of insulin which is continued at discharge)
    • The development of severe GI bleeding (e.g., necessitating unplanned transfusion and/or endoscopy) and;
    • inpatient length of stay (censored at day 60; deaths assigned 60 days).

Secondary outcomes

  1. Death

    Time frame: Day 60

    Mortality at day 60

  2. relapse of PCP-related hypoxemia

    Time frame: Day 60

    (Relapse of PCP-related hypoxemia that is 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. Secondary infections requiring systemic antibiotic therapy

    Time frame: Day 60

    The development of secondary infections requiring systemic antibiotic therapy

  4. The development of severe diabetic complications

    Time frame: Day 60

    Severe complications of diabetes include: ketoacidosis, hyperosmolar coma, new initiation of insulin which is continued at discharge

  5. The development of severe GI bleeding (

    Time frame: Day 60

    Gastrointestinal bleeding necessitating unplanned transfusion and/or endoscopy

  6. inpatient length of stay (censored at day 60; deaths assigned 60 days).

    Time frame: Day 60

    inpatient length of stay censored at day 60; deaths assigned 60 days.

Other outcomes

  1. Quality of life (EQ-5D-5L)

    Time frame: Day 30

    Higher score indicates better quality of life

  2. Quality of life (EQ-5D-5L)

    Time frame: Day 180

    Higher score indicates better quality of life

  3. All-cause mortality

    Time frame: Day 180

    all cause mortality

  4. PCP recurrence

    Time frame: Day 180

    recurrence of PCP infection following the initial infection

Study contacts

Contact information is provided by the study sponsor or research team.

Babykumari Chitramuthu, PhD

CONTACT

[email protected]

15149341934 ext. 23730

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

How Long Should we Give Steroids for Patients With Severe PCP (HOW LONG)

Acronym: HOW LONG

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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