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RPX7009(beta-lactamase inhibitor) is being studied in combination with carbapenem (RPX2014)to treat bacterial infections, including those due to multi-drug resistant bacteria.
Full description
The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.
Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2014) plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of intravenous RPX2014 and RPX7009, administered in combination in subjects with varying degrees of renal insufficiency.
Enrollment
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Inclusion criteria
Exclusion criteria
Unstable or new medical conditions (e.g., cardiovascular, respiratory, hepatic, renal, gastrointestinal, autoimmune, endocrine, or neurological disorders)
Hypersensitivity or idiosyncratic reaction to β-lactam antibiotics (e.g. penicillins, cephalosporins, or carbapenems)
History of clinically significant seizures, head injury, or meningitis.
Current evidence or history of malignancy, excluding basal cell carcinoma, in the 2 years prior to Day -1 with no evidence of recurrence.
Females who are pregnant, lactating, or have a positive pregnancy test
Previously received any dose of Carbavance (RPX2014/RPX7009).
Current participation in another investigational study or participation in another investigational clinical study within 30 days prior to the Screening Visit.
Blood donation or significant blood loss (i.e., > 500 mL) within 56 days prior to Day 1.
Plasma or platelet donation within 14 days prior to Day -1.
Any acute illness requiring antibiotic drug therapy within 30 days prior to Day 1 or a febrile illness within 7 days prior to Day 1.
Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the study.
Positive urine drug/alcohol test at the Screening Visit or Day -1
Concurrent use of medications known to affect the elimination of serum creatinine (e.g., trimethoprim/sulfamethoxazole [Bactrim®] or cimetidine [Tagamet®]) and competitors of renal tubular secretion (e.g., probenecid) within 30 days prior to the first dose of study drug
Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis
Use of any other prescription or nonprescription drugs, vitamins, grapefruit/grapefruit juice or dietary or herbal supplements within 14 days prior to Day -1.
Currently receives hemodialysis or peritoneal dialysis.
Primary purpose
Allocation
Interventional model
Masking
32 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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