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Trial terminated due to financial resource limitations
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The purpose of this study is to compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours [q12h]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose 1 iclaprim |
|
| 2 | Experimental | Dose 2 iclaprim |
|
| 3 | Active Comparator | vancomycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iclaprim | Drug |
| ||
| vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin | at test of cure (TOC) visit | |
| Efficacy: Iclaprim clinical cure rates | at TOC and end of therapy (EOT) | |
| Safety |
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Inclusion Criteria:
Suspected or confirmed acute bacterial pneumonia due to Gram-positive pathogens in one of the following subgroups:
hospital-acquired pneumonia (HAP), i.e., pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; or
ventilator-associated pneumonia (VAP), i.e., pneumonia that arises more than 48 hours after endotracheal intubation; or
health-care-associated pneumonia (HCAP), i.e., pneumonia diagnosed within 48 hours of hospital admission, in a patient who fulfills at least one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Willms, MD | Sharp HealthCare | Principal Investigator |
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|
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C486448 | iclaprim |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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