PneumocystisPhase 4SPIRIT-ALTNCT07357103
Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives)
A Phase 4 study testing Clindamycin + primaquine, Pentamidine and Atovaquone in people with Pneumocystis and Pneumocystis Infection, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
The usual first treatment for Pneumocystis jirovecii pneumonia (PCP) is an antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX). However, some patients cannot take this medication because of allergies, side effects, or lack of response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis, Pneumocystis Infection, Pneumocystis Carinii Infection
- What is being tested?
- Clindamycin + primaquine, Pentamidine and Atovaquone
- 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
- No sites listed yet
- Study dates
- Mar 2026to Sep 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
- Immunocompromised patients (including but not limited to HIV, solid organ transplant, solid tumors, hematological transplant and malignancies, systemic diseases, chemotherapy, long term corticosteroid use, and immunosuppressive therapies, as well as primary immunodeficiencies) in an emergency department, cliinic, or hospital
- Age ≥18 years
- Proven or probable Pneumocystis jirovecii pneumonia
- Inability to receive trimethoprim-sulfamethoxazole due to contraindication, intolerance, toxicity, or treatment failure
- Immunocompromised status
- Ability to provide informed consent (or per local regulations)
- While participants may be enrolled in multiple domains of the SPIRIT-PCP Platform over time (if they are eligible and a domain is active), they may only be enrolled to single question once (e.g., they can be part PCP Alternatives and an eventual secondary prophylaxis domain; however, if they have a recurrence, they cannot be included in PCP Alternatives again).
Who cannot join
- The Platform will exclude: patients where we are unable to obtain informed consent, where patients or their proxy have declined to consent, where the treating team has declined participation, where follow up cannot be reliably obtained (e.g., lack of means of communication, patient non-resident of jurisdiction), where treatment with antibiotics is not in keeping with a patient's advanced care directives, and where death is deemed imminent (<48h) as determined by the treating team and site investigator.
- Clinical:
- Previous severe adverse reaction or hypersensitivity to clindamycin, primaquine, or atovaquone (mild-moderate PCP) or to clindamycin, primaquine, or pentamidine (severe PCP);
- More than 7 calendar days of any therapy for PCP (no more than 4 can involve a study drug).
- Known pregnancy or breastfeeding (pregnancy test will be offered)
- Drug specific exclusion criteria:
Show all 21Show fewer
- For clindamycin-primaquine:
- Known G6PD deficiency OR family history of G6PD deficiency without excluding by testing*
- Known diagnosis of porphyria
- Concomitant use of methotrexate or cyclophosphamide which cannot be held *G6PD deficiency is an X-linked recessive genetic disease. Female patients without a family history are very unlikely to have this disease and so therapy can start while waiting for the test in the absence of a family history. Male patients should wait for test results prior to receiving primaquine even if they do not have a family history. For those without G6PD testing at diagnosis, it is a reasonable standard of care to order testing.
- For pentamidine:
- Absence of adequate intravenous access as determined by treating team and site investigator. In the event of loss of IV, up to 2 consecutive doses can be given intramuscularly if the patient is not systemically anticoagulated and does not have a coagulopathy.
- Hypotension defined as systolic blood pressure below 90mmHg without pharmacologic support
- Personal history of Torsade de Pointes or presence of a corrected QTc of greater than 490ms on ECG on date of enrollment
- For atovaquone:
- Receipt of PCP Prophylaxis (≥3 doses per week) for ≥ 4 weeks with atovaquone
- inability to tolerate atovaquone with a meal or enteral feeding (e.g., prolonged NPO status is an exclusion as atovaquone must be taken with food for proper absorption)
- Concurrent use of rifampin, rifabutin, or tetracycline (that cannot be stopped)
- Reduced gastric absorption (patient must not have a medical condition which the treating team and/or site investigator believes will interfere with atovaquone absorption, e.g., total gastrectomy)
- Administrative:
- 1. Trial site not participating in PCP Alternatives branch of the initial therapy domain
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives) [A Branch of the Initial Treatment Domain of the SPIRIT-PCP Platform]
The usual first treatment for Pneumocystis jirovecii pneumonia (PCP) is an antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX). However, some patients cannot take this medication because of allergies, side effects, or lack of response.
This study asks the question:
When TMP-SMX cannot be used, which alternative treatment for PCP provides the best balance of effectiveness and safety?
Read the detailed description
Pneumocystis jirovecii pneumonia (PCP) is a serious lung infection that affects people with weakened immune systems (e.g., patients with cancer, organ transplants, autoimmune diseases, or HIV). Without timely treatment, PCP can lead to respiratory failure and death.
TMP-SMX is the standard first-line treatment, but 20-30% of patients cannot receive the treatment or cannot tolerate it due to allergic reactions, kidney problems, low blood counts, drug interactions, or treatment failure. In these situations, doctors use alternative medications such as clindamycin with primaquine, pentamidine, or atovaquone.
Although these alternative treatments are widely used, there is limited modern research directly comparing them. As a result, treatment choices vary between hospitals and physicians.
The main objective of this study is to determine which alternative treatment works best for patients with PCP who cannot receive TMP-SMX. Eligible participants in the PCP alternatives therapy are enrolled and randomized centrally 1:1 in the MUHC Research Electronic Data Capture (REDCap) system. The primary outcome is a Hierarchical composite Win Ratio Outcome at day 30: death; new extracorporeal membrane oxygenation (ECMO), new invasive mechanical ventilation; severe (CTCAE grade 4) adverse drug event; and length of stay in hospital (amongst survivors). 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, Pneumocystis Infection, Pneumocystis Carinii Infection, Pneumocystis Carinii; Infection, Resulting From HIV Disease, Pneumocystis Jirovecii Pneumonia, Pneumocystis Jirovecii Infection
- Being tested
- Clindamycin + primaquine, Pentamidine, Atovaquone
- Keywords
- PCP, Pneumocystis jirovecii pneumonia, PCP Alternatives, Clindamycin, Pentamidine, Primaquine, Atovaquone, HIV, Non-HIV, Immunocompromised host, Randomized Control Trial
- 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.
Clindamycin + primaquineDrug
Participants randomized to this intervention will receive clindamycin in combination with primaquine as second-line therapy for the treatment of PCP.
This regimen may be used for participants with Severe PCP or mild to moderate PCP in acccordance with protocol-defined disease severity and standard clinical practice.
PentamidineDrug
Participants randomized to this intervention will receive pentamidine, administered intravenously, as second-line therapy for the treatment of PCP in patients with severe disease who are unable to tolerate or have contraindications to trimethoprim-sulfamethoxazole (TMP/SMX)
AtovaquoneDrug
Participants randomized to. this intervention will receive atovaquone, administered orally, as second-line therapy for the treatment of PCP in participants with mild to moderate disease who are unable to tolerate or have contraindications to trimethoprim-sulfamethozaxole (TMP/SMX).
| Study group | Role | What they receive |
|---|---|---|
| Severe PCP-Clindamycin+primaquine | Experimental | Participants with severe PCP will be randomized to receive clindamycin in combination with primaquine as second-line therapy due to intolerance of or contraindications to trimethoprim-sulfamethoxazole. Receives: Drug: Clindamycin + primaquine |
| Severe PCP-Intravenous Pentamidine | Experimental | Participants with severe PCP will be randomized to receive intravenous pentamidine as second-line therapy due to intolerance of or contraindications to trimethoprim-sulfamethoxazole. Receives: Drug: Pentamidine |
| Mild to Moderate PCP- Clindamycin+primaquine | Experimental | Participants with mild to moderate PCP will be randomized to receive clindamycin in combination with primaquine as second-line therapy due to intolerance of or contraindications to trimethoprim-sulfamethoxazole. Receives: Drug: Clindamycin + primaquine |
| Mild to moderate PCP- Atovaquone | Experimental | Participants with mild to moderate PCP will be randomized to receive atovaquone as second-line therapy due to intolerance of or contraindications to trimethoprim-sulfamethoxazole. Receives: Drug: Atovaquone |
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)
Mortality at day 30
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 posted21 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumocystisStudies 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
- Investigators
- Emily G McDonald, MD MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreTodd C Lee, MD MPH, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMatthew P Cheng, MD FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357103
- Sponsor's protocol ID
- 2026-12268
- Other IDs
- 527077
- Acronym
- SPIRIT-ALT
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymized patient data will be shared for one year, released one year following the publication of the primary PCP Alternatives Manuscript. Data will be accessible through reasonable request to Emily McDonald at emily.mcdonald@mcgill.ca and with an inter-institutional agreement in place.
Publications
Del Corpo O, Butler-Laporte G, Sheppard DC, Cheng MP, McDonald EG, Lee TC. Diagnostic accuracy of serum (1-3)-beta-D-glucan for Pneumocystis jirovecii pneumonia: a systematic review and meta-analysis. Clin Microbiol Infect. 2020 Sep;26(9):1137-1143. doi: 10.1016/j.cmi.2020.05.024. Epub 2020 May 30.
PubMed 32479781McDonald EG, Afshar A, Assiri B, Boyles T, Hsu JM, Khuong N, Prosty C, So M, Sohani ZN, Butler-Laporte G, Lee TC. Pneumocystis jirovecii pneumonia in people living with HIV: a review. Clin Microbiol Rev. 2024 Mar 14;37(1):e0010122. doi: 10.1128/cmr.00101-22. Epub 2024 Jan 18.
PubMed 38235979McDonald 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives) [A Branch of the Initial Treatment Domain of the SPIRIT-PCP Platform]
- ClinicalTrials.gov ID
- NCT07357103
- Acronym / sponsor ID
- SPIRIT-ALT / 2026-12268
- Conditions
- Pneumocystis, Pneumocystis Infection, Pneumocystis Carinii Infection, Pneumocystis Carinii; Infection, Resulting From HIV Disease, Pneumocystis Jirovecii Pneumonia, Pneumocystis Jirovecii Infection
- Keywords
- PCP, Pneumocystis jirovecii pneumonia, PCP Alternatives, Clindamycin, Pentamidine, Primaquine, Atovaquone, HIV
- 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
- Mar 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 21 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 usual first treatment for Pneumocystis jirovecii pneumonia (PCP) is an antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX). However, some patients cannot take this medication because of allergies, side effects, or lack of response.
This study asks the question:
When TMP-SMX cannot be used, which alternative treatment for PCP provides the best balance of effectiveness and safety?
Detailed description
Pneumocystis jirovecii pneumonia (PCP) is a serious lung infection that affects people with weakened immune systems (e.g., patients with cancer, organ transplants, autoimmune diseases, or HIV). Without timely treatment, PCP can lead to respiratory failure and death.
TMP-SMX is the standard first-line treatment, but 20-30% of patients cannot receive the treatment or cannot tolerate it due to allergic reactions, kidney problems, low blood counts, drug interactions, or treatment failure. In these situations, doctors use alternative medications such as clindamycin with primaquine, pentamidine, or atovaquone.
Although these alternative treatments are widely used, there is limited modern research directly comparing them. As a result, treatment choices vary between hospitals and physicians.
The main objective of this study is to determine which alternative treatment works best for patients with PCP who cannot receive TMP-SMX. Eligible participants in the PCP alternatives therapy are enrolled and randomized centrally 1:1 in the MUHC Research Electronic Data Capture (REDCap) system. The primary outcome is a Hierarchical composite Win Ratio Outcome at day 30: death; new extracorporeal membrane oxygenation (ECMO), new invasive mechanical ventilation; severe (CTCAE grade 4) adverse drug event; and length of stay in hospital (amongst survivors). 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe PCP-Clindamycin+primaquine | Experimental | Drug: Clindamycin + primaquineParticipants with severe PCP will be randomized to receive clindamycin in combination with primaquine as second-line therapy due to intolerance of or contraindications to trimethoprim-sulfamethoxazole. |
| Severe PCP-Intravenous Pentamidine | Experimental | Drug: PentamidineParticipants with severe PCP will be randomized to receive intravenous pentamidine as second-line therapy due to intolerance of or contraindications to trimethoprim-sulfamethoxazole. |
| Mild to Moderate PCP- Clindamycin+primaquine | Experimental | Drug: Clindamycin + primaquineParticipants with mild to moderate PCP will be randomized to receive clindamycin in combination with primaquine as second-line therapy due to intolerance of or contraindications to trimethoprim-sulfamethoxazole. |
| Mild to moderate PCP- Atovaquone | Experimental | Drug: AtovaquoneParticipants with mild to moderate PCP will be randomized to receive atovaquone as second-line therapy due to intolerance of or contraindications to trimethoprim-sulfamethoxazole. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Immunocompromised patients (including but not limited to HIV, solid organ transplant, solid tumors, hematological transplant and malignancies, systemic diseases, chemotherapy, long term corticosteroid use, and immunosuppressive therapies, as well as primary immunodeficiencies) in an emergency department, cliinic, or hospital
- While participants may be enrolled in multiple domains of the SPIRIT-PCP Platform over time (if they are eligible and a domain is active), they may only be enrolled to single question once (e.g., they can be part PCP Alternatives and an eventual secondary prophylaxis domain; however, if they have a recurrence, they cannot be included in PCP Alternatives again).
Key exclusion criteria (21 listed)
- The Platform will exclude: patients where we are unable to obtain informed consent, where patients or their proxy have declined to consent, where the treating team has declined participation, where follow up cannot be reliably obtained (e.g., lack of means of communication, patient non-resident of jurisdiction), where treatment with antibiotics is not in keeping with a patient's advanced care directives, and where death is deemed imminent (<48h) as determined by the treating team and site investigator.
- Previous severe adverse reaction or hypersensitivity to clindamycin, primaquine, or atovaquone (mild-moderate PCP) or to clindamycin, primaquine, or pentamidine (severe PCP);
- More than 7 calendar days of any therapy for PCP (no more than 4 can involve a study drug).
- Known pregnancy or breastfeeding (pregnancy test will be offered)
- For clindamycin-primaquine:
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 |
|---|---|---|
| Clindamycin + primaquineParticipants randomized to this intervention will receive clindamycin in combination with primaquine as second-line therapy for the treatment of PCP. This regimen may be used for participants with Severe PCP or mild to moderate PCP in acccordance with protocol-defined disease severity and standard clinical practice. | Drug | Mild to Moderate PCP- Clindamycin+primaquine, Severe PCP-Clindamycin+primaquine |
| PentamidineParticipants randomized to this intervention will receive pentamidine, administered intravenously, as second-line therapy for the treatment of PCP in patients with severe disease who are unable to tolerate or have contraindications to trimethoprim-sulfamethoxazole (TMP/SMX) | Drug | Severe PCP-Intravenous Pentamidine |
| AtovaquoneParticipants randomized to. this intervention will receive atovaquone, administered orally, as second-line therapy for the treatment of PCP in participants with mild to moderate disease who are unable to tolerate or have contraindications to trimethoprim-sulfamethozaxole (TMP/SMX). | Drug | Mild to moderate PCP- Atovaquone |
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 21 Jan 2026.
- Results publication: PubMed 32479781Del Corpo O, Butler-Laporte G, Sheppard DC, Cheng MP, McDonald EG, Lee TC. Diagnostic accuracy of serum (1-3)-beta-D-glucan for Pneumocystis jirovecii pneumonia: a systematic review and meta-analysis. Clin Microbiol Infect. 2020 Sep;26(9):1137-1143. doi: 10.1016/j.cmi.2020.05.024. Epub 2020 May 30.
- Results publication: PubMed 38235979McDonald EG, Afshar A, Assiri B, Boyles T, Hsu JM, Khuong N, Prosty C, So M, Sohani ZN, Butler-Laporte G, Lee TC. Pneumocystis jirovecii pneumonia in people living with HIV: a review. Clin Microbiol Rev. 2024 Mar 14;37(1):e0010122. doi: 10.1128/cmr.00101-22. Epub 2024 Jan 18.
- Results publication: 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. Individual anonymized patient data will be shared for one year, released one year following the publication of the primary PCP Alternatives Manuscript. Data will be accessible through reasonable request to Emily McDonald at emily.mcdonald@mcgill.ca and with an inter-institutional agreement in place.
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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.
Emily G McDonald, MD MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Todd C Lee, MD MPH principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Matthew P Cheng, MD FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clindamycin + primaquine, Pentamidine and Atovaquone in people with Pneumocystis and Pneumocystis Infection, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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 7 inclusion and 21 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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 NCT07357103, which also lists 3 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 21 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.