Treatment of Pneumocystitis in COPD (the TOPIC Study)
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
Chronic obstructive pulmonary disease (COPD) is a progressive lung disease associated with
chronic inflammation in the airways and lung, resulting in significant morbidity and
mortality worldwide. Smoking is the primary risk factor for development of COPD and
progression of the disease is associated with acute exacerbations of COPD (AECOPD) that can
be triggered by acute bacterial or viral airway infections or can occur independently of
infection. AECOPD can lead to hospitalization, progression of the disease, and mortality.
COPD affects an estimated 11.7% of the world population and was the third leading cause of
death worldwide in 2019.
This study is a randomized, double-blinded and placebo controlled study to determine if
treating PJ in AECOPD with confirmed PJ colonization has a beneficial clinical impact. As a
secondary goal of the study, it will be determined if TMP-SMX can decolonize these patients
and if the decolonization is durable for at least 3 months.
The causes of progression of COPD, especially in the absence of continued tobacco use, are
incompletely understood and a significant area of need. One proposed trigger for progression
and increased AECOPD is colonization (presence of the organism without an actual infection)
with Pneumocystis jirovecii (PJ), a fungal pathogen best known for causing pneumonia in
patients with HIV or other forms of immunosuppression. It has been found to be more prevalent
in those with severe COPD, particularly during AECOPD, but as a colonizer, not a cause of
acute pneumonia. Several studies have linked PJ with progression of COPD, showing that PJ
perpetuates an inflammatory and lung remodeling response, contributing to development of
airway obstruction, emphysema and accelerating the disease course.
The aim of this study is to add trimethoprim-sulfamethoxazole (TMP-SMX) to standard of care
treatment of AECOPD in patients who are colonized with PJ will improve the clinical outcome
for the patient. This study is a pilot which will serve as proof of concept that screening
for PJ in the AECOPD population and treating it with the commonly available, safe, and
inexpensive antibiotic TMP-SMX will be an effective strategy.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
William Beaumont Hospitals
Treatments:
Sulfamethoxazole Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination