Status:
TERMINATED
Treatment of Pneumocystis in COPD (the TOPIC Study)
Lead Sponsor:
Corewell Health East
Conditions:
COPD Exacerbation Acute
Eligibility:
All Genders
40-89 years
Phase:
PHASE1
PHASE2
Brief 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. Smo...
Detailed Description
The current standard of care for detection of PJ has significant limitations in COPD patients. There is no reliable in vitro culture system and traditional detection methods are based on histochemical...
Eligibility Criteria
Inclusion
- Carries the diagnosis of COPD and admitted for and admitted with AECOPD to Beaumont, Royal Oak (AECOPD requires increased cough, increased sputum production, and shortness of breath +/- increased oxygen needs from baseline)
- Able to produce a sputum sample
- Men or women, age ≥ 40 and \< 90
- Previously enrolled in the EPIC Study and positive for Pneumocystis jirovecii detected in their sputum
- Currently treated with steroids
- Kidney function not severely impaired (CrCl ≥ 60)
- AST and ALT ≤5x upper limit of normal
- Willing and able to consent to the study
Exclusion
- Current diagnosis of pneumonia or COVID-19
- Allergy or hypersensitivity to trimethoprim-sulfamethoxazole
- Current ICU admission or mechanical ventilation
- Active cancer or chemotherapy (except non-melanoma skin cancer)
- Other potentially confounding pulmonary diagnosis
- HIV, leukopenia, neutropenia, or other immunosuppressive condition or current use of immunosuppressive medications
- Presence of gastrointestinal tract abnormalities that would prevent absorption of medications
- Patients with concomitant infection requiring antibiotics active against Pneumocystis jirovecii
- Concomitant use of coumadin, phenytoin, pioglitazone, repaglinide, rosiglitazone, glipizide or glyburide
- Megaloblastic anemia due to folate deficiency
- Pregnancy
- Life expectancy less than 3 months
Key Trial Info
Start Date :
September 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05418777
Start Date
September 28 2022
End Date
December 19 2022
Last Update
November 29 2023
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073