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| Name | Class |
|---|---|
| Vaibhav Mokashi | UNKNOWN |
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We aim to conduct a pilot trial assessing oral versus intravenous therapy for pleural space infections.
Pleural space infections are a frequent clinical problem resulting in significant morbidity and mortality as well as healthcare cost. Despite the increasing burden of disease, there are no clinical trials evaluating antibiotic therapy in pleural space infections. Hence, British and American guidelines are only able to provide weak and vague recommendations regarding duration, type or route (intravenous or oral) of antibiotic therapy. Our goal is to determine whether oral (PO) therapy is non-inferior to intravenous (IV) therapy thereby decreasing risks of IV catheter related infections, vein thrombosis and health care costs. Similar studies have been successfully conducted in the setting of bone/joint infections and endocarditis and showed non-inferiority of oral antibiotics. However, in order to help ensure that the randomized trial is of good quality, it is important to assess the feasibility of such a trial by first conducting a pilot study. The goal of this pilot trial is to assess the feasibility of the proposed study design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous therapy | Active Comparator | Intravenous antibiotics administered for pleural space infection |
|
| Oral therapy | Active Comparator | Oral antibiotics administered for pleural space infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics | Drug | Oral versus intravenous therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment feasibility | Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure | 3 months |
| Completion feasibility | Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | Treatment failure at the 3-month clinical visit or phone conversation, defined as any of: (i) return to the emergency department for new fever, shortness of breath or progressive hypoxia OR (ii) radiological progression of empyema or development of a new abscess OR (iii) mortality related to pleural space infection. Treatment failure must be agreed upon by the majority of the adjudication committee. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 3 months |
| Mortality | All-cause mortality at 3 months | 3 months |
| Antibiotic duration | Duration of antibiotics with start date as the date of randomization | 3 months |
| Hospitalization duration | Duration of hospitalization | 3 months |
| Stopping antibiotics | Early termination of antibiotics due to patient intolerance, patient preference or any other reason. | 3 months |
| IV line complications | Infection, thrombosis or new line placement for IV catheter-related issues. | 3 months |
| C. difficile | Clostridium difficile associated diarrhea as per the accepted PIDAC definition | 3 months |