Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
Recruiting
Phase 3
Interventional Study
Pneumocystis
Pneumocystis Pneumonia
Pneumocystis Jirovecii Infection
Pneumocystis Infections
Pneumocystis Carinii Infection
Pneumocystosis; Pneumonia (Etiology)
Pneumocystis Carinii; Infection, Resulting From HIV Disease
Pneumocystosis Associated With AIDS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 416 (estimated)
- Sponsor
- Todd C. Lee MD MPH FIDSA · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 primar…
Contacts