PneumocystisPhase 3LOW-DOSENCT04851015
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
A Phase 3 study testing trimethoprim-sulfamethoxazole in people with Pneumocystis and Pneumocystis Pneumonia, run by Todd C. Lee MD MPH FIDSA at 1 site in Canada.
Trial summary
Pneumocystis jirovecii pneumonia (PCP) is an opportunistic fungal infection of immunocompromised hosts which causes in significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of TMP, is associated with serious adverse events, including… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pneumocystis, Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
- What is being tested?
- trimethoprim-sulfamethoxazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2025to 31 Dec 2030
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Immunocompromised (including but not limited to HIV, solid organ transplant, solid tumors, hematological stem cell transplant and malignancies, systemic diseases, chemotherapy, long term corticosteroid use, and immunosuppressive therapies, as well as primary immunodeficiencies
- Presentation to a day hospital, emergency department, or admitted to hospital
- Proven or probable diagnosis of PCP using an adapted version of the 2021 EORTC/MSGERC criteria.
Who cannot join
- Previous severe adverse reaction to TMP-SMX, any sulfa drug, or any component of formulation
- Compliant with PCP prophylaxis for ≥4 weeks with TMP-SMX at enrollment
- More than 96 hours of any therapy for PCP
- Hepatic impairment marked by alanine aminotransferase levels ≥5 times the upper limit of normal
- Known G6PD deficiency
- Known diagnosis of porphyria
Show all 9Show fewer
- Known pregnancy or breastfeeding (as per Health Canada)
- Unable to provide informed consent and no available healthcare proxy (with ethics approval for deferred consent in cases of critical illness); refusal of consent; no reliable means of outpatient contact (telephone/email/text);
- Previously enrolled
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, 1 recruiting
- Recruiting
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, H4A3J1
Babykumari Chitramuthu, PhD, 514-934-1934 ext. 23730, babykumari.chitramuthu@muhc.mcgill.ca
Kristen Moran, 514-934-1934 ext. 23730, kristen.moran@mail.mcgill.ca
About this study
Pneumocystis jirovecii pneumonia (PCP) is an opportunistic fungal infection of immunocompromised hosts which causes in significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of TMP, is associated with serious adverse events, including hypersensitivity reactions, drug-induced liver injury, cytopenia, and renal failure occurring among 20-60% of patients. The frequency of adverse events increases in a dose dependent manner and commonly limits the use of TMP-SMX.
Reduced treatment doses of TMP-SMX for PCP reduced ADEs without mortality differences in a recent meta-analysis of observational studies. We therefore propose a Phase III randomized, placebo-controlled trial to directly compare the efficacy and safety of low dose (10 mg/kg/day of TMP) compared to the standard-of-care (15 mg/kg/day) among patients with PCP for the primary outcome of Win Ratio hierarchical composite of death, ECMO, invasive ventilation, grade 4 toxicity, non-invasive ventilation, change of therapy and length of stay.
Read the detailed description
Pneumocystis jirovecii pneumonia (PCP) is an opportunistic fungal infection primarily affecting immunocompromised patients. Adults with HIV (particularly CD4 ≤200 cells/µL), solid organ and allogeneic hematopoietic stem cell transplant recipients, as well as patients on certain chemotherapies, immunosuppressant drugs, and systemic corticosteroids are at a highest risk. Although routine primary prophylaxis has diminished its prevalence, PCP still results in significant morbidity and mortality worldwide. Retrospective cohort studies have reported mortality rates between 20-50% among non-HIV populations and 10-20% for patients with HIV.
Current guidelines from the National Institutes of Health (NIH), the HIV Medicine Association of the Infectious Diseases Society of America (IDSA), and the American Society of Transplantation (AST) all recommend weight-based trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of the trimethoprim component as the standard of care. Yet, higher doses of TMP-SMX are associated with serious adverse events, including hypersensitivity reactions, drug-induced liver injury, cytopenia, and renal failure with adverse drug events (ADEs) reported among 20-60% of patients on treatment.
To better inform the optimal dosing strategy for PCP therapy, we recently performed a systematic review and meta-analysis of reduced dose regimens of TMP-SMX in the treatment of PCP among immunocompromised adult patients with and without HIV. When comparing standard doses to reduced doses (≤10mg/kg/day of the TMP component), there was no statistically significant difference in mortality (absolute risk difference: -9% in favor of reduced dose, 95% CI: -27% to 8%) with a corresponding 18% (95% CI: -31% to -5%) absolute risk reduction of Grade III or higher adverse events. These data provide the best available evidence for treatment equipoise and highlight the need for a randomized controlled trial to directly compare dosing strategies.
The primary objective of this trial is to determine whether treatment with reduced-dose TMP-SMX (10mg/kg/day) is superior to standard dose (15mg/kg/day) among immunocompromised HIV-infected and uninfected patients with PCP for the primary outcome of Win Ratio hierarchical composite of death, ECMO, invasive ventilation, grade 4 toxicity, non-invasive ventilation, change of therapy and length of stay, new mechanical ventilation, or change in treatment by Day 30.
- Conditions
- Pneumocystis, Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection, Pneumocystis Infections, Pneumocystis Carinii Infection, Pneumocystosis; Pneumonia (Etiology)
- Being tested
- trimethoprim-sulfamethoxazole
- Keywords
- Pneumocystis, PCP, PJP, immunosuppressed, HIV, TMP-SMX
- Medical subject headings
- Pneumonia, Pneumocystis, Pneumocystis Infections, Pneumonia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trimethoprim-sulfamethoxazoleDrug
Also called Reduced dose
10mg/kg/day of TMP component
trimethoprim-sulfamethoxazoleDrug
Also called Standard dose
15mg/kg/day of TMP component
| Study group | Role | What they receive |
|---|---|---|
| Reduced dose TMP-SMX | Experimental | Trimethoprim-Sulfamethoxazole at a total dose of 10mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as a dose of 10mg/kg/day open label with additional placebo tablets or intravenous placebo solution given to simulate 15mg/kg/day. All doses will be adjusted for obesity and renal function. Receives: Drug: trimethoprim-sulfamethoxazole |
| Standard dose TMP-SMX | Active comparator | Trimethoprim-Sulfamethoxazole at a total dose of 15mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as 10mg/kg/day open label plus an extra masked 5mg/kg/day of tablets or intravenous solution. All doses will be adjusted for obesity and renal function. Receives: Drug: trimethoprim-sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite outcome
Hierarchical composite of Win Ratio at day 30:
- death;
- new extracorporeal membrane oxygenation (ECMO),
- new invasive mechanical ventilation;
- severe (CTCAE grade 4) adverse drug event (dermatologic, nephrologic, hematologic, neurologic, and/or endocrinologic) considered at least probable (by Leape and Bates criteria);
- new non-invasive ventilation;
- change of therapy (i.e., dose or agent) due to presumed treatment failure or probable adverse drug reaction (by Leape and Bates criteria); and
- length of stay in hospital (amongst survivors)
Measured: Day 30
Secondary outcomes (7)
Proportion of patients that die (death)
All cause mortality
Measured: Day 30
Proportion of patients with a need for new extracorporeal membrane oxygenation (ECMO)
New initiation of extracorporeal membrane oxygenation during hospitalization following initiation of assigned PCP treatment strategy.
Measured: Day 30
Proportion of patients requiring new Invasive Mechanical Ventilation
Initiation of invasive mechanical ventilation via endotracheal intubation during hospitalization following initiation of the assigned PCP treatment strategy.
Measured: Day 30
. Proportion of patients with severe (CTCAE grade 4) adverse drug event
Proportion of patients with occurence of severe (CTCAE grade 4) adverse drug event (dermatologic, nephrologic, hematologic, neurologic, and/or endocrinologic) considered at least probable (by Leape and Bates criteria).
Measured: Day 30
Proportion of patients with need for new non-invasive ventilation
initiation of non-invasive ventilation (including continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP] during hospitalization following initiation of the assigned PCP treatment strategy.
Measured: Day 30
Proportion of patients requiring escalation or change of PCP -directed therapy
Proportion of patients with escalation or change of PCP -directed therapy due to inadequate clinical response, disease progression, or treatment-limiting toxicity during the treatment or follow-up period.
Measured: Day 30
Median length of stay in hospital amongst survivors
Length of hospital stay, measured in days from hospital admission to discharge among participants who survive to hospital discharge.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start28 Nov 2025
- Primary completion30 Sep 2030 (estimated)
- Study completion31 Dec 2030 (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 PneumocystisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Todd C. Lee MD MPH FIDSA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Todd C. Lee MD MPH FIDSA, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Emily G McDonald, MD MSc, Principal investigator, Research Institute of the McGill University Health CentreTodd C Lee, MD MPH FIDSA, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851015
- Sponsor's protocol ID
- 2021-7386
- Acronym
- LOW-DOSE
- Status last verified
- Feb 2026
- First submitted
- 12 Apr 2021
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A copy of a trial data required to replicate trial publication analyses will be shared within 3-6 months of publication. After study completion, a fully de-identified copy of the full trial dataset can be made available to other researchers subject to a data sharing agreement enacted under Quebec law.
Publications
Butler-Laporte G, Smyth E, Amar-Zifkin A, Cheng MP, McDonald EG, Lee TC. Low-Dose TMP-SMX in the Treatment of Pneumocystis jirovecii Pneumonia: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2020 Apr 2;7(5):ofaa112. doi: 10.1093/ofid/ofaa112. eCollection 2020 May.
PubMed 32391402Sohani ZN, Butler-Laporte G, Aw A, Belga S, Benedetti A, Carignan A, Cheng MP, Coburn B, Costiniuk CT, Ezer N, Gregson D, Johnson A, Khwaja K, Lawandi A, Leung V, Lother S, MacFadden D, McGuinty M, Parkes L, Qureshi S, Roy V, Rush B, Schwartz I, So M, Somayaji R, Tan D, Trinh E, Lee TC, McDonald EG. Low-dose trimethoprim-sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (LOW-TMP): protocol for a phase III randomised, placebo-controlled, dose-comparison trial. BMJ Open. 2022 Jul 21;12(7):e053039. doi: 10.1136/bmjopen-2021-053039.
PubMed 35863836
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
- ClinicalTrials.gov ID
- NCT04851015
- Acronym / sponsor ID
- LOW-DOSE / 2021-7386
- Conditions
- Pneumocystis, Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection, Pneumocystis Infections, Pneumocystis Carinii Infection, Pneumocystosis; Pneumonia (Etiology)
- Keywords
- Pneumocystis, PCP, PJP, immunosuppressed, HIV, TMP-SMX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Todd C. Lee MD MPH FIDSAUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Apr 2021 (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.
Pneumocystis jirovecii pneumonia (PCP) is an opportunistic fungal infection of immunocompromised hosts which causes in significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of TMP, is associated with serious adverse events, including hypersensitivity reactions, drug-induced liver injury, cytopenia, and renal failure occurring among 20-60% of patients. The frequency of adverse events increases in a dose dependent manner and commonly limits the use of TMP-SMX.
Reduced treatment doses of TMP-SMX for PCP reduced ADEs without mortality differences in a recent meta-analysis of observational studies. We therefore propose a Phase III randomized, placebo-controlled trial to directly compare the efficacy and safety of low dose (10 mg/kg/day of TMP) compared to the standard-of-care (15 mg/kg/day) among patients with PCP for the primary outcome of Win Ratio hierarchical composite of death, ECMO, invasive ventilation, grade 4 toxicity, non-invasive ventilation, change of therapy and length of stay.
Detailed description
Pneumocystis jirovecii pneumonia (PCP) is an opportunistic fungal infection primarily affecting immunocompromised patients. Adults with HIV (particularly CD4 ≤200 cells/µL), solid organ and allogeneic hematopoietic stem cell transplant recipients, as well as patients on certain chemotherapies, immunosuppressant drugs, and systemic corticosteroids are at a highest risk. Although routine primary prophylaxis has diminished its prevalence, PCP still results in significant morbidity and mortality worldwide. Retrospective cohort studies have reported mortality rates between 20-50% among non-HIV populations and 10-20% for patients with HIV.
Current guidelines from the National Institutes of Health (NIH), the HIV Medicine Association of the Infectious Diseases Society of America (IDSA), and the American Society of Transplantation (AST) all recommend weight-based trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of the trimethoprim component as the standard of care. Yet, higher doses of TMP-SMX are associated with serious adverse events, including hypersensitivity reactions, drug-induced liver injury, cytopenia, and renal failure with adverse drug events (ADEs) reported among 20-60% of patients on treatment.
To better inform the optimal dosing strategy for PCP therapy, we recently performed a systematic review and meta-analysis of reduced dose regimens of TMP-SMX in the treatment of PCP among immunocompromised adult patients with and without HIV. When comparing standard doses to reduced doses (≤10mg/kg/day of the TMP component), there was no statistically significant difference in mortality (absolute risk difference: -9% in favor of reduced dose, 95% CI: -27% to 8%) with a corresponding 18% (95% CI: -31% to -5%) absolute risk reduction of Grade III or higher adverse events. These data provide the best available evidence for treatment equipoise and highlight the need for a randomized controlled trial to directly compare dosing strategies.
The primary objective of this trial is to determine whether treatment with reduced-dose TMP-SMX (10mg/kg/day) is superior to standard dose (15mg/kg/day) among immunocompromised HIV-infected and uninfected patients with PCP for the primary outcome of Win Ratio hierarchical composite of death, ECMO, invasive ventilation, grade 4 toxicity, non-invasive ventilation, change of therapy and length of stay, new mechanical ventilation, or change in treatment by Day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced dose TMP-SMX | Experimental | Drug: trimethoprim-sulfamethoxazoleTrimethoprim-Sulfamethoxazole at a total dose of 10mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as a dose of 10mg/kg/day open label with additional placebo tablets or intravenous placebo solution given to simulate 15mg/kg/day. All doses will be adjusted for obesity and renal function. |
| Standard dose TMP-SMX | Active comparator | Drug: trimethoprim-sulfamethoxazoleTrimethoprim-Sulfamethoxazole at a total dose of 15mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as 10mg/kg/day open label plus an extra masked 5mg/kg/day of tablets or intravenous solution. All doses will be adjusted for obesity and renal function. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Immunocompromised (including but not limited to HIV, solid organ transplant, solid tumors, hematological stem cell transplant and malignancies, systemic diseases, chemotherapy, long term corticosteroid use, and immunosuppressive therapies, as well as primary immunodeficiencies
- Presentation to a day hospital, emergency department, or admitted to hospital
- Proven or probable diagnosis of PCP using an adapted version of the 2021 EORTC/MSGERC criteria.
Key exclusion criteria (9 listed)
- Previous severe adverse reaction to TMP-SMX, any sulfa drug, or any component of formulation
- Compliant with PCP prophylaxis for ≥4 weeks with TMP-SMX at enrollment
- More than 96 hours of any therapy for PCP
- Hepatic impairment marked by alanine aminotransferase levels ≥5 times the upper limit of normal
- Known G6PD deficiency
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 |
|---|---|---|
| trimethoprim-sulfamethoxazoleAlso: Reduced dose10mg/kg/day of TMP component | Drug | Reduced dose TMP-SMX |
| trimethoprim-sulfamethoxazoleAlso: Standard dose15mg/kg/day of TMP component | Drug | Standard dose TMP-SMX |
Primary outcome
Hierarchical composite outcome
Time frame: Day 30
Hierarchical composite of Win Ratio at day 30: * death; * new extracorporeal membrane oxygenation (ECMO), * new invasive mechanical ventilation; * severe (CTCAE grade 4) adverse drug event (dermatologic, nephrologic, hematologic, neurologic, and/or endocrinologic) considered at least probable (by Leape and Bates criteria); * new non-invasive ventilation; * change of therapy (i.e., dose or agent) due to presumed treatment failure or probable adverse drug reaction (by Leape and Bates criteria); and * length of stay in hospital (amongst survivors)
7 secondary outcomes
Proportion of patients that die (death)
Time frame: Day 30
Proportion of patients with a need for new extracorporeal membrane oxygenation (ECMO)
Time frame: Day 30
Proportion of patients requiring new Invasive Mechanical Ventilation
Time frame: Day 30
. Proportion of patients with severe (CTCAE grade 4) adverse drug event
Time frame: Day 30
Proportion of patients with need for new non-invasive ventilation
Time frame: Day 30
Proportion of patients requiring escalation or change of PCP -directed therapy
Time frame: Day 30
Median length of stay in hospital amongst survivors
Time frame: Day 30
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 20 Feb 2026.
- Background: PubMed 32391402Butler-Laporte G, Smyth E, Amar-Zifkin A, Cheng MP, McDonald EG, Lee TC. Low-Dose TMP-SMX in the Treatment of Pneumocystis jirovecii Pneumonia: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2020 Apr 2;7(5):ofaa112. doi: 10.1093/ofid/ofaa112. eCollection 2020 May.
- Derived from this study: PubMed 35863836Sohani ZN, Butler-Laporte G, Aw A, Belga S, Benedetti A, Carignan A, Cheng MP, Coburn B, Costiniuk CT, Ezer N, Gregson D, Johnson A, Khwaja K, Lawandi A, Leung V, Lother S, MacFadden D, McGuinty M, Parkes L, Qureshi S, Roy V, Rush B, Schwartz I, So M, Somayaji R, Tan D, Trinh E, Lee TC, McDonald EG. Low-dose trimethoprim-sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (LOW-TMP): protocol for a phase III randomised, placebo-controlled, dose-comparison trial. BMJ Open. 2022 Jul 21;12(7):e053039. doi: 10.1136/bmjopen-2021-053039.
- Individual participant dataSharing planned: Yes. A copy of a trial data required to replicate trial publication analyses will be shared within 3-6 months of publication. After study completion, a fully de-identified copy of the full trial dataset can be made available to other researchers subject to a data sharing agreement enacted under Quebec law.
Related trials for Pneumocystis
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
Active, not recruiting
Improving PCP Advance Care Planning for People With ADRD
Alzheimer Disease, Dementia
Not yet recruiting
Cascade Testing In Identifying At-risk Family Members Of Individuals With Familial Hypercholesterolemia (FH) In PCP
Familial Hypercholesterolemia
Not yet recruitingPhase 2/3
Intra Articular Injection of Peripheral Blood Mononuclear Cells for Knee Osteoarthritis
Knee Osteoarthritis
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.
Emily G McDonald, MD MSc principal investigator
Research Institute of the McGill University Health Centre
Todd C Lee, MD MPH FIDSA principal investigator
Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trimethoprim-sulfamethoxazole in people with Pneumocystis and Pneumocystis Pneumonia, run by Todd C. Lee MD MPH FIDSA 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (514-934-1934 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 outcome (time frame: Day 30). 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 NCT04851015, 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 20 Feb 2026.