Conditions: Infections, Intestinal
Keywords: intra-abdominal infection belly Gram-negative pathogen abscess peritonitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
This study is being conducted to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cIAI.

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: q8h administered via IV infusion, plus saline placebo

Interventions: intervention 1: Drug: GSK2251052 intervention 2: Meropenem intervention 3: Placebo
Intervention descriptions: intervention 1: Reconstituted, added to 250mL 0.9% NaCl solution and administered via IV infusion intervention 2: Reconstituted, added to 100mL 0.9% NaCl solution and administered via IV infusion intervention 3: saline placebo

Protocol document: