Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives)

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

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

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

About this trial

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?

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

Clindamycin + primaquine
Pentamidine
Atovaquone

Treatment groups

416 Participants

are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

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

Lead sponsor

Source ClinicalTrials.gov