Table 1.

Summary of studies included in the analysis

Protocol number	Clinical trial number	Design/objective	Number of participants/patient population	Imipenem doses	Relebactam doses
PN001	NA	Phase I, four‐part, double‐blind, randomized, placebo‐controlled, sequential‐panel, rising single dose study, and a sequential panel, multiple‐rising‐dose study to evaluate safety, tolerability and PK of relebactam	83 healthy males, 18–45 years of age	500 mg or 500 mg q6h for 7 or 14 days	25, 50, 125, 250, 500, 1,000, and 1,150 mg or 50, 125, 250, 375, 500, and 625 mg q6h for 7–14 days
PN002	NA	Phase I, randomized, double‐blind, placebo‐controlled, single‐dose study in healthy elderly male, healthy elderly female, and healthy young female participants to evaluate safety, tolerability, and PK of relebactam	18 healthy participants, 26–75 years of age	500 mg	125 mg
PN003	NCT01505634	Phase II, randomized (1:1:1), double‐blind, comparator‐controlled study to evaluate the efficacy (microbiological response at end of therapy) and safety of relebactam vs. imipenem in adult participants with cUTI	261 hospitalized adults with cUTI, 18–90 years of age	500 mg q6h for 4–14 days	125 or 250 mg q6h for 4–14 days
PN004	NCT01506271	Phase II, randomized (1:1:1), double‐blind, comparator‐controlled study to evaluate the efficacy and safety of relebactam vs. imipenem in adult participants with cIAI	313 hospitalized adults with cIAI, 18–88 years of age	500 mg q6h for 4–14 days	125 or 250 mg q6h for 4–14 days
PN005	NCT01275170	Phase I, open‐label, single‐dose study to evaluate safety, tolerability, and PK of relebactam in participants with impaired renal function	30 participants with renal impairment, 34–75 years of age, 18 healthy matching control participants	250 mg	125 mg
PN007	NA	Phase I, open‐label, multiple‐dose study to evaluate the relationship between the intrapulmonary PK of relebactam with respect to the intrapulmonary PK of imipenem in healthy participants	16 healthy participants, 24–42 years of age	500 mg q6h for 5 total doses	250 mg q6h for 5 total doses
PN009	NA	Phase I, single‐dose, double‐blind, randomized, placebo and positive‐controlled, three‐period, balanced crossover study under fasting conditions	36 healthy participants, 22–55 years of age		1,150 mg
PN012	NA	Phase I, randomized, placebo‐controlled, double‐blind, single‐dose and multiple‐dose trial of relebactam and imipenem/cilastatin in healthy Japanese male participants	16 healthy male Japanese participants, 20–45 years of age	Panels A and B: 500 mg	Panel A: 125 or 500 mg, or 500 mg q6h for 14 days Panel B: 250 mg or 250 mg q6h for 14 days
PN013	NCT02452047	Phase III, randomized (2:1), double‐blind, comparator‐controlled study to evaluate the efficacy and safety of relebactam vs. colistin (as CMS) + imipenem in participants with imipenem‐resistant infection	50 hospitalized adults with HABP/VABP, cUTI, or cIAI, 19–80 years of age	500/250 mg imipenem + relebactam (FDC) q6h + placebo q12h 300 mg CMS (LD) and 150 mg CMS q12h (MD) + 500 mg imipenem q6h for 5, 7, or 21 days
PN019	NA	Phase I, open‐label, randomized, two‐period, crossover study	14 healthy Japanese participants, 23–55 years of age	500 mg	250 mg

cIAI, complicated intra‐abdominal infection; CMS, colistimethate sodium; cUTI, complicated urinary tract infection; FDC, fixed‐dose combination; HABP, hospital‐associated bacterial pneumonia; LD, loading dose; MD, multiple dose; NA, not available; PK, pharmacokinetics; q12h, every 12 hours; q6h, every 6 hours; VABP, ventilator‐associated bacterial pneumonia.