Pneumocystis PneumoniaPhase 4HOW LONGNCT07328984
How Long Should we Give Steroids for Patients With Severe PCP
A Phase 4 study testing Systemic corticosteroids in people with Pneumocystis Pneumonia and Pneumocystis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis Pneumonia, Pneumocystis, Pneumocystis Jirovecii Infection
- What is being tested?
- Systemic corticosteroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2026to Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McGill university Health Centre (Royal victoria Hospital and Montreal General Hospital
Montreal, Quebec, H4A 3J1
Babykumari Chitramuthu, PhD, 5149341934 ext. 23730, babykumari.chitramuthu@muhc.mcgill.ca
Emily G McDonald, MD MSc
About this study
Official title: How Long Should we Give Steroids for Patients With Severe PCP (HOW LONG)
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.
Read the detailed description
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.
- Conditions
- Pneumocystis Pneumonia, Pneumocystis, Pneumocystis Jirovecii Infection, Pneumocystis Jiroveci Pneumonia, Pneumocystis Carinii; Infection, Resulting From HIV Disease, Pneumocystosis Associated With AIDS
- Being tested
- Systemic corticosteroids
- Keywords
- PCP, Systemic Corticosteroids, De-escalation of Therapy, Randomized Control Trial, Immunocompromised host, HIV, Non-HIV, Pneumocystis jirovecii pneumonia
- Medical subject headings
- Pneumonia, Pneumocystis, Pneumocystis Infections, Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic corticosteroidsDrug
Adjunctive systemiccorticosteroid therapy administered as part of standard treatment for pneumocystis Pneumonia, with duration varying by study arm.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Systemic corticosteroids |
| Standard duration of Corticosteroids | Active comparator | Continue adjunctive systemic corticosteroids to a total of 21 days (standard of care). Receives: Drug: Systemic corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite clinical outcome
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).
Measured: Day 60
Secondary outcomes (6)
Death
Mortality at day 60
Measured: Day 60
relapse of PCP-related hypoxemia
(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
Measured: Day 60
Secondary infections requiring systemic antibiotic therapy
The development of secondary infections requiring systemic antibiotic therapy
Measured: Day 60
The development of severe diabetic complications
Severe complications of diabetes include: ketoacidosis, hyperosmolar coma, new initiation of insulin which is continued at discharge
Measured: Day 60
The development of severe GI bleeding (
Gastrointestinal bleeding necessitating unplanned transfusion and/or endoscopy
Measured: Day 60
inpatient length of stay (censored at day 60; deaths assigned 60 days).
inpatient length of stay censored at day 60; deaths assigned 60 days.
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumocystis PneumoniaStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328984
- Sponsor's protocol ID
- 2026-12265
- Other IDs
- 527077
- Acronym
- HOW LONG
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be made available upon reasonable request to the principal investigator by email (emily.mcdonald@mcgill.ca) subject to discussion surrounding the necessity of an interinstitutional data sharing agreement, commencing one year following the publication of the main trial results, for a period of 2 years.
Publications
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.
PubMed 34464734McDonald 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.
PubMed 34988242
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Long Should we Give Steroids for Patients With Severe PCP (HOW LONG)
- ClinicalTrials.gov ID
- NCT07328984
- Acronym / sponsor ID
- HOW LONG / 2026-12265
- Conditions
- Pneumocystis Pneumonia, Pneumocystis, Pneumocystis Jirovecii Infection, Pneumocystis Jiroveci Pneumonia, Pneumocystis Carinii; Infection, Resulting From HIV Disease, Pneumocystosis Associated With AIDS
- Keywords
- PCP, Systemic Corticosteroids, De-escalation of Therapy, Randomized Control Trial, Immunocompromised host, HIV, Non-HIV, Pneumocystis jirovecii pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shortened-Duration Corticosteroids | Experimental | Drug: Systemic corticosteroidsDiscontinue adjunctive systemic corticosteroids at day 10 of therapy or at hospital discharge (whichever occurs first), after documented clinical recovery (room air for ≥6 hours). |
| Standard duration of Corticosteroids | Active comparator | Drug: Systemic corticosteroidsContinue adjunctive systemic corticosteroids to a total of 21 days (standard of care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic corticosteroidsAdjunctive systemiccorticosteroid therapy administered as part of standard treatment for pneumocystis Pneumonia, with duration varying by study arm. | Drug | Shortened-Duration Corticosteroids, Standard duration of Corticosteroids |
Primary outcome
Hierarchical composite clinical outcome
Time frame: Day 60
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).
6 secondary outcomes
Death
Time frame: Day 60
relapse of PCP-related hypoxemia
Time frame: Day 60
Secondary infections requiring systemic antibiotic therapy
Time frame: Day 60
The development of severe diabetic complications
Time frame: Day 60
The development of severe GI bleeding (
Time frame: Day 60
inpatient length of stay (censored at day 60; deaths assigned 60 days).
Time frame: Day 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 34464734Senecal 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.
- Background: PubMed 34988242McDonald 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be made available upon reasonable request to the principal investigator by email (emily.mcdonald@mcgill.ca) subject to discussion surrounding the necessity of an interinstitutional data sharing agreement, commencing one year following the publication of the main trial results, for a period of 2 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Systemic corticosteroids in people with Pneumocystis Pneumonia and Pneumocystis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Babykumari Chitramuthu, PhD (15149341934 ext. 23730, babykumari.chitramuthu@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite clinical outcome (time frame: Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07328984, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.