Conditions: Infections, Urinary Tract
Keywords: Gram-negative uropathogens complicated lower urinary tract infection pyelonephritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.

Detailed description:

Arms:
arm 1: q12h administered via IV infusion, plus saline placebo arm 2: q12h administered via IV infusion, plus saline placebo arm 3: 500 mg imipenem monohydrate and 500 mg cilastatin sodium; q6h administered via IV infusion, plus saline placebo

Interventions: intervention 1: GSK2251052 intervention 2: imipenem-cilastatin intervention 3: Placebo
Intervention descriptions: intervention 1: Reconstituted, added to 250mL 0.9% NaCl solution and administered via IV infusion intervention 2: Prepare as per prescribing information instructions in 100 mL bag of 0.9% NaCl and administered via IV infusion intervention 3: saline placebo

Protocol document: