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NCT05418777 · ClinicalTrials.gov registry record · Phase 1
Treatment of Pneumocystis in COPD (the TOPIC Study)
A Phase 1 study, sponsored by Corewell Health East.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT05418777 is a Phase 1 study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 1 participants.
The verdict
NCT05418777, a Phase 1 study, was terminated before completion, sponsored by Corewell Health East.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study 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 w
Interventions
- DRUG Placebo
- DRUG Trimethoprim Sulfamethoxazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-09-28 |
| Est. Completion | 2022-12-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05418777
The ClinicalTrials.gov registry entry for NCT05418777 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health East, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05418777 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05418777 about?
NCT05418777 is a clinical study titled "Treatment of Pneumocystis in COPD (the TOPIC Study)". 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...
What is the current status of trial NCT05418777?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2022-09-28. Estimated completion is 2022-12-19.
What interventions are being tested in trial NCT05418777?
The interventions under investigation include: Placebo (DRUG), Trimethoprim Sulfamethoxazole (DRUG).
Who is sponsoring clinical trial NCT05418777?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
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