{"id":105,"date":"2023-08-29T13:14:44","date_gmt":"2023-08-29T13:14:44","guid":{"rendered":"https:\/\/www.merckconnect.com\/zerbaxa\/?page_id=105"},"modified":"2026-03-24T09:38:48","modified_gmt":"2026-03-24T09:38:48","slug":"clinical-efficacy-ciai","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/zerbaxa\/clinical-efficacy-ciai\/","title":{"rendered":"Clinical efficacy against cIAIs"},"content":{"rendered":"<link rel='stylesheet' id='vivid360-heading-css-css' href='https:\/\/www.merckconnect.com\/zerbaxa\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/heading\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"vivid360-heading\" id=\"a099e0c82-d9fd-4fd9-b897-30ee6eac4f4a\"><h1 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:36px;--tabletFontSize:36px;--mobileFontSize:24px;--desktopLineHeightSize:45px;--tabletLineHeightSize:45px;--mobileLineHeightSize:\" id=\"top\"><strong>Clinical efficacy of ZERBAXA\u00ae (ceftolozane and tazobactam) against cIAIs<br><\/strong><\/h1><\/div>\n\n\n<link rel='stylesheet' id='vivid360-spacer-css-css' href='https:\/\/www.merckconnect.com\/zerbaxa\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/spacer\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div style=\"background-color:transparent;--desktop-spacer:24px;--tablet-spacer:24px;--mobile-spacer:24px;height:24px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"aa1b3bbf2-cccc-475a-b9d4-8eb209933887\"><h2 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>Learn about:<\/strong><\/h2><\/div>\n\n\n<link rel='stylesheet' id='vivid360-list-css-css' href='https:\/\/www.merckconnect.com\/zerbaxa\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/list\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"vivid-block-list content-width  default-list block-39a58ceb-ffba-406a-8142-1faf12eae1f4 custom-colored-hyperlink\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-39a58ceb-ffba-406a-8142-1faf12eae1f4\"><ul class=\"first-level\"><li><em><a href=\"#cIAIadult\">cIAI in adult patients<\/a><\/em><\/li><li><em><a href=\"#cIAIpediatric\">cIAI in pediatric patients<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"a8b7b40d8-764b-4861-8561-241c4a6286e3\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"cIAIadult\"><strong>Complicated intra-abdominal infections (cIAIs) in adult patients<\/strong><\/h3><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>A total of 979 adults hospitalized with cIAI were randomized and received study medications in a multinational, double-blind study comparing ZERBAXA 1.5 g (ceftolozane 1 g and tazobactam <span class=\"no-wrap-text\">0.5 g<\/span>) intravenously every 8 hours plus metronidazole (500 mg intravenously every 8 hours) to meropenem <span class=\"no-wrap-text\">(1 g<\/span> intravenously every 8 hours) for 4 to 14 days of therapy. Complicated intra-abdominal infections included appendicitis, cholecystitis, diverticulitis, gastric\/duodenal perforation, perforation of the intestine, and other causes of intra-abdominal abscesses and peritonitis. The majority of patients (75%) were from Eastern Europe; 6.3% were from the United States.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The primary efficacy endpoint was clinical response, defined as complete resolution or significant improvement in signs and symptoms of the index infection at the test-of-cure (TOC) visit which occurred 24 to 32 days after the first dose of study drug. The primary efficacy analysis population was the microbiological intent-to-treat (MITT) population, which included all patients who had at least 1 baseline intra-abdominal pathogen regardless of the susceptibility to study drug. The key secondary efficacy endpoint was clinical response at the TOC visit in the microbiologically evaluable (ME) population, which included all protocol-adherent MITT patients.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The MITT population consisted of 806 patients; the median age was 52 years and 57.8% were male. The most common diagnosis was appendiceal perforation or peri-appendiceal abscess, occurring in 47% of patients. Diffuse peritonitis at baseline was present in 34.2% of patients.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>ZERBAXA plus metronidazole was non-inferior to meropenem with regard to clinical cure rates at the TOC visit in the MITT population. Clinical cure rates at the TOC visit are displayed by patient population in the table below. Clinical cure rates at the TOC visit by pathogen in the MITT population are presented in the table below.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"aced0e5be-f062-4384-be4e-0da8c0af49db\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"\">Clinical cure rates in a Phase 3 trial of complicated intra-abdominal infections in adult patients<\/h3><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:70%\">\n<figure class=\"wp-block-flexible-table-block-table is-scroll-on-mobile\"><table class=\"\"><tbody><tr><td style=\"background-color:#bf5411;text-align:center;font-size:14px;border-color:#435363 #fff #435363 #435363\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-white-color\"><span class=\"no-wrap-text\">Analysis population<\/span><\/mark><\/strong><\/td><td style=\"text-align:center;font-size:14px;background-color:#bf5411;border-color:#435363 #fff #435363 #435363\"><strong><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-white-color\">ZERBAXA plus <span class=\"no-wrap-text\">metronidazole<sup>a<\/sup><\/span>&nbsp;<span class=\"no-wrap-text\">n\/N (%)<\/span><\/mark><\/strong><\/strong><\/td><td style=\"text-align:center;font-size:14px;background-color:#bf5411;border-color:#435363 #fff #435363 #435363\"><strong><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-white-color\"><span class=\"no-wrap-text\">Meropenem<sup>b<\/sup><\/span>&nbsp;n\/N (%)<\/mark><\/strong><\/strong><\/td><td style=\"background-color:#bf5411;color:#FFF;font-size:14px;text-align:center;width:25%;border-color:#435363\"><strong><span class=\"no-wrap-text\">Treatment difference<\/span><\/strong><br><strong>(95% CI)<sup>c<\/sup><\/strong><\/td><\/tr><tr><td style=\"background-color:#FFF;color:#000;text-align:center;font-size:14px;border-color:#435363\"><strong>MITT\u2002<\/strong><\/td><td style=\"background-color:#FFF;color:#000;text-align:center;font-size:14px;border-color:#435363\">323\/389 (83)<\/td><td style=\"background-color:#FFF;color:#000;text-align:center;font-size:14px;border-color:#435363\">364\/417 (87.3)<\/td><td style=\"font-size:14px;color:#000;background-color:#FFF;text-align:center;border-color:#435363\">-4.3 (-9.2, 0.7)<\/td><\/tr><tr><td style=\"background-color:#FFF;color:#000;text-align:center;font-size:14px;padding:12px;border-color:#435363\"><strong>ME<\/strong><\/td><td style=\"color:#000;text-align:center;font-size:14px;background-color:#FFF;border-color:#435363\">259\/275 (94.2)<\/td><td style=\"color:#000;text-align:center;font-size:14px;background-color:#FFF;border-color:#435363\">304\/321 (94.7)<\/td><td style=\"font-size:14px;color:#000;background-color:#FFF;text-align:center;border-color:#435363\">-0.5 (-4.5, 3.2)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-small-font-size\"><sup>a<\/sup>ZERBAXA 1.5 g intravenously every 8 hours + metronidazole <span class=\"no-wrap-text\">500 mg<\/span> intravenously every 8 hours.<br><sup>b<\/sup>1 gram intravenously every 8 hours.<br><sup>c<\/sup>The 95% confidence interval (CI) was calculated as an unstratified Wilson Score CI.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:30%\"><\/div>\n<\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"ac3f0ab18-366d-4ec6-9fec-3213bc60746c\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"\">Clinical cure rates by pathogen in a Phase 3 trial of complicated intra-abdominal infections in adult patients (MITT population)<\/h3><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:8px;--tablet-spacer:8px;--mobile-spacer:0px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div class=\"wp-block-columns mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top mb-0 is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:65%\">\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<figure class=\"wp-block-flexible-table-block-table is-scroll-on-mobile mb-0\"><table class=\"\"><thead><tr><th style=\"background-color:#bf5411;color:#FFF;border-style:solid;text-align:left;padding-left:14px;border-width:1px 2px 2px 1px;border-color:#435363 #fff #FFF #435363\"><strong><span class=\"no-wrap-text\">Organism<\/span> <span class=\"no-wrap-text\">group pathogen<\/span><\/strong><\/th><th style=\"background-color:#bf5411;color:#FFF;border-style:solid;text-align:center;border-width:1px 2px 2px 1px;border-color:#435363 #fff #FFF #435363\"><strong>ZERBAXA plus <span class=\"no-wrap-text\">metronidazole<\/span><\/strong><br><strong>n\/N (%)<\/strong><\/th><th style=\"background-color:#bf5411;color:#FFF;border-style:solid;text-align:center;border-width:1px 1px 2px;border-color:#435363 #435363 #FFF\"><strong><span class=\"no-wrap-text\">Meropenem<\/span> <\/strong><br><strong>n\/N (%)<\/strong><\/th><\/tr><\/thead><tbody><tr><td colspan=\"3\" style=\"background-color:#bf5411;color:#FFF;text-align:left;padding-left:14px;border-color:#435363 #bf5411 #435363 #435363\"><strong>Aerobic Gram-negative<\/strong><\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;border-color:#435363;color:#000\"><em>Escherichia coli<\/em><\/td><td style=\"text-align:center;border-color:#435363;color:#000\">216\/255 (84.7)<\/td><td style=\"text-align:center;border-color:#435363;color:#000\">238\/270 (88.1)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;color:#000;border-color:#435363\"><em>Klebsiella pneumoniae<\/em><\/td><td style=\"text-align:center;color:#000;border-color:#435363\">31\/41 (75.6)<\/td><td style=\"text-align:center;color:#000;border-color:#435363\">27\/35 (77.1)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;border-color:#435363;color:#000\"><em>Pseudomonas aeruginosa<\/em><\/td><td style=\"text-align:center;border-color:#435363;color:#000\">30\/38 (79)<\/td><td style=\"text-align:center;border-color:#435363;color:#000\">30\/34 (88.2)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;color:#000;border-color:#435363\"><em>Enterobacter cloacae<\/em><\/td><td style=\"text-align:center;color:#000;border-color:#435363\">21\/26 (80.8)<\/td><td style=\"text-align:center;color:#000;border-color:#435363\">24\/25 (96)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;border-color:#435363;color:#000\"><em>Klebsiella oxytoca<\/em><\/td><td style=\"text-align:center;border-color:#435363;color:#000\">14\/16 (87.5)<\/td><td style=\"text-align:center;border-color:#435363;color:#000\">24\/25 (96)<\/td><\/tr><tr><td style=\"text-align:center;color:#000;border-color:#435363\"><em>Proteus mirabilis<\/em><\/td><td style=\"text-align:center;color:#000;border-color:#435363\">11\/12 (91.7)<\/td><td style=\"text-align:center;color:#000;border-color:#435363\">9\/10 (90)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;color:#000;border-color:#435363;font-size:0\"><em>Proteus mirabilis<\/em><\/td><td style=\"text-align:center;color:#000;border-color:#435363;font-size:0\">11\/12 (91.7)<\/td><td style=\"text-align:center;color:#000;border-color:#435363;font-size:0\">9\/10 (90)<\/td><\/tr><tr><td colspan=\"3\" style=\"background-color:#bf5411;color:#FFF;text-align:left;padding-left:14px;border-color:#435363 #bf5411 #435363 #435363\"><strong>Aerobic Gram-positive<\/strong><\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;border-color:#435363;color:#000\"><em>Streptococcus anginosus<\/em><\/td><td style=\"text-align:center;border-color:#435363;color:#000\">26\/36 (72.2)<\/td><td style=\"text-align:center;border-color:#435363;color:#000\">24\/27 (88.9)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;border-color:#435363;color:#000\"><em>Streptococcus constellatus<\/em><\/td><td style=\"text-align:center;border-color:#435363;color:#000\">18\/24 (75)<\/td><td style=\"text-align:center;border-color:#435363;color:#000\">20\/25 (80)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;border-color:#435363;color:#000\"><em>Streptococcus salivarius<\/em><\/td><td style=\"text-align:center;border-color:#435363;color:#000\">9\/11 (81.8)<\/td><td style=\"text-align:center;border-color:#435363;color:#000\">9\/11 (81.8)<\/td><\/tr><tr><td colspan=\"3\" style=\"background-color:#bf5411;color:#FFF;text-align:left;padding-left:14px;border-color:#435363 #bf5411 #435363 #435363\"><strong>Anerobic Gram-negative<\/strong><\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;border-color:#435363;color:#000\"><em>Bacteroides fragilis<\/em><\/td><td style=\"text-align:center;border-color:#435363;color:#000\">42\/47 (89.4)<\/td><td style=\"text-align:center;border-color:#435363;color:#000\">59\/64 (92.2)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;color:#000;border-color:#435363\"><em>Bacteroides ovatus<\/em><\/td><td style=\"text-align:center;color:#000;border-color:#435363\">38\/45 (84.4)<\/td><td style=\"text-align:center;color:#000;border-color:#435363\">44\/46 (95.7)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;color:#000;border-color:#435363\"><em>Bacteroides <span class=\"no-wrap-text\">thetaiotaomicron<\/span><\/em><\/td><td style=\"text-align:center;color:#000;border-color:#435363\">21\/25 (84)<\/td><td style=\"text-align:center;color:#000;border-color:#435363\">40\/46 (87)<\/td><\/tr><tr><td style=\"text-align:center;padding-left:14px;color:#000;border-color:#435363\"><em>Bacteroides vulgatus<\/em><\/td><td style=\"text-align:center;color:#000;border-color:#435363\">12\/15 (80)<\/td><td style=\"text-align:center;color:#000;border-color:#435363\">24\/26 (92.3)<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:35%\"><\/div>\n<\/div>\n\n\n\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<p>In a subset of the&nbsp;<em>E. coli<\/em>&nbsp;and&nbsp;<em>K. pneumoniae<\/em>&nbsp;isolates from both arms of the cIAI Phase 3 trial that met pre-specified criteria for beta-lactam susceptibility, genotypic testing identified certain ESBL groups (e.g., TEM, SHV, CTX-M, OXA) in 53\/601 (9%). Cure rates in this subset were similar to the overall trial results.&nbsp;In vitro&nbsp;susceptibility testing showed that some of these isolates were susceptible to ZERBAXA (MIC \u2264 2 mcg\/mL), while some others were not susceptible (MIC &gt;<span class=\"no-wrap-text\">2 mcg\/mL<\/span>). Isolates of a specific genotype were seen in patients who were deemed to be either successes or failures.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid-block-list content-width  use-image-all block-3542455c-8bd8-4fee-b666-1df8f37ef034 custom-colored-hyperlink\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-3542455c-8bd8-4fee-b666-1df8f37ef034\"><ul class=\"first-level\"><li><em><a href=\"#top\">Back to top<\/a><\/em><\/li><li><em><a href=\"#cIAIadult\">cIAI in adult patients<\/a><\/em><\/li><li><em><a href=\"#cIAIpediatric\">cIAI in pediatric patients<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"a7e33e70e-8948-4e2a-8881-02f56b1fa8d4\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"cIAIpediatric\"><strong>Complicated intra-abdominal infections (cIAIs) in pediatric patients<\/strong><\/h3><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The pediatric cIAI trial was a randomized, double-blind, multi-center, active controlled trial conducted in hospitalized patients from birth to less than 18 years (NCT03217136). Patients were randomized in a 3:1 ratio to either intravenous (IV) ZERBAXA plus metronidazole (10 mg\/kg IV every 8 hours), or meropenem (20 mg\/kg IV every 8 hours) plus placebo. Patients received IV study treatment for a minimum of 3 days before an optional switch to oral step-down therapy at the discretion of the investigator to complete a total of 5 to 14 days of antibacterial therapy.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The modified intent-to-treat (MITT) population consisted of 91 patients (N=70 in the ZERBAXA plus metronidazole group; N=21 in the meropenem plus placebo group) who were randomized and received at least one dose of study treatment. The median age of patients was 8.2 years and 8.5 years in the ZERBAXA plus metronidazole and meropenem plus placebo groups, respectively. In the ZERBAXA plus metronidazole group, enrollment by age group was as follows: 12 to &lt;18 y: n=16, 6 to &lt;12 y: n=30, 2 to &lt;6 y: n=22, 3 months to &lt;2 y: n=1, birth to &lt;3 months: n=1. Patients treated with ZERBAXA plus metronidazole were predominantly male (67%) and White (87%). Patients treated with meropenem plus placebo were predominantly female (71%) and White (91%). Most patients in the MITT population had a diagnosis of complicated appendicitis at baseline (ZERBAXA plus metronidazole: 91.4%; meropenem plus placebo: 100%). The median (range) duration of IV study treatment was comparable between patients in the ZERBAXA plus metronidazole (6.3 [0.3 to 14.0] days) and meropenem plus placebo (6.0 [2.3 to 8.8] days) groups.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<p>The primary objective of the study was to evaluate the safety and tolerability of ZERBAXA. Efficacy assessments were not powered for formal hypothesis testing of between-treatment group comparisons. At the TOC visit, which occurred 7 to 14 days after the last dose of study drug, a favorable clinical response was defined as complete resolution or marked improvement in signs and symptoms of the cIAI or return to pre-infection signs and symptoms such that no further antibiotic therapy (IV or oral) or surgical or drainage procedure was required for treatment of the cIAI. A summary of clinical response rates in the MITT and clinically evaluable (CE) populations at the TOC visit are presented in the table below. The CE included all protocol adherent MITT patients with a clinical outcome at the visit of interest.<\/p>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"ad0f8222f-4e6e-4ea4-a02c-e320a22e4496\"><h3 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h3FontSizeDesktop);--tabletFontSize:var(--h3FontSizeDesktop);--mobileFontSize:var(--h3FontSizeMobile);--desktopLineHeightSize:var(--h3LineHeightDesktop);--tabletLineHeightSize:var(--h3LineHeightDesktop);--mobileLineHeightSize:\" id=\"\">Clinical response rates in a pediatric study of complicated intra-abdominal infections<\/h3><\/div>\n\n\n\n<div class=\"wp-block-columns mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:65%\">\n<div style=\"background-color:transparent;height:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-16\"><\/div>\n\n\n\n<figure class=\"wp-block-flexible-table-block-table is-scroll-on-mobile\"><table class=\"\"><thead><tr><th style=\"background-color:#bf5411;color:#FFF;text-align:center;font-size:14px;line-height:1.2;border-color:#435363 #FFF #435363 #435363\">Analysis<br><span class=\"no-wrap-text\">population<\/span><\/th><th style=\"background-color:#bf5411;color:#FFF;text-align:center;font-size:14px;line-height:1.2;border-color:#435363 #FFF #435363 #435363\"><span class=\"no-wrap-text\">ZERBAXA<\/span> plus<br><span class=\"no-wrap-text\">metronidazole<\/span> n\/N (%)<\/th><th style=\"background-color:#bf5411;color:#FFF;text-align:center;font-size:14px;line-height:1.2;border-color:#435363 #FFF #435363 #435363\"><span class=\"no-wrap-text\">Meropenem<\/span><br>n\/N (%)<\/th><th style=\"background-color:#bf5411;color:#FFF;text-align:center;font-size:14px;line-height:1.2;border-color:#435363\"><span class=\"no-wrap-text\">Treatment<\/span> difference<br>(95% CI)<strong><sup>d<\/sup><\/strong><\/th><\/tr><\/thead><tbody><tr><td style=\"text-align:center;font-size:14px;padding:10px 8px;border-color:#435363;color:#000\">MITT <span class=\"no-wrap-text\">Population<\/span><\/td><td style=\"text-align:center;font-size:14px;padding:10px 8px;border-color:#435363;color:#000\">56\/70 (80.0)<\/td><td style=\"text-align:center;font-size:14px;padding:10px 8px;border-color:#435363;color:#000\">21\/21 (100.0)<\/td><td style=\"text-align:center;font-size:14px;padding:10px 8px;border-color:#435363;color:#000\">-19.1 (-30.2, -2.9)<\/td><\/tr><tr><td style=\"text-align:center;font-size:14px;background-color:#e6e7e8;padding:10px 8px;border-color:#435363;color:#000\">CE <span class=\"no-wrap-text\">Population<\/span><\/td><td style=\"text-align:center;font-size:14px;background-color:#e6e7e8;padding:10px 8px;border-color:#435363;color:#000\">52\/58 (89.7)<\/td><td style=\"text-align:center;font-size:14px;background-color:#e6e7e8;padding:10px 8px;border-color:#435363;color:#000\">19\/19 (100.0)<\/td><td style=\"text-align:center;font-size:14px;background-color:#e6e7e8;padding:10px 8px;border-color:#435363;color:#000\">-10.7 (-21.5, 6.8)<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:35%\"><\/div>\n<\/div>\n\n\n\n<p class=\"has-small-font-size\"><sup>d<\/sup>The Miettinen &amp; Nurminen method stratified by age group with Cochran-Mantel-Haenszel weights was used.<\/p>\n\n\n\n<div class=\"vivid-block-list content-width  use-image-all block-83d1e0cd-ca8f-4516-acb8-185a8ae3e5a6 custom-colored-hyperlink\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-83d1e0cd-ca8f-4516-acb8-185a8ae3e5a6\"><ul class=\"first-level\"><li><em><a href=\"#top\">Back to top<\/a><\/em><\/li><li><em><a href=\"#cIAIadult\">cIAI in adult patients<\/a><\/em><\/li><li><em><a href=\"#cIAIpediatric\">cIAI in pediatric patients<\/a><\/em><\/li><\/ul><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:24px;--tablet-spacer:24px;--mobile-spacer:24px;height:24px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>A total of 979 adults hospitalized with cIAI were randomized and received study medications in a multinational, double-blind study comparing ZERBAXA 1.5&#8230;<\/p>\n","protected":false},"author":750,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[267],"ga4_page_businessunit":[],"ga4_page_campaign":[],"ga4_page_content_purpose":[294],"ga4_page_customer_journey_stage":[334],"ga4_page_customer_specialty":[358],"ga4_page_experience":[],"ga4_page_indication":[],"ga4_page_material_intent":[522],"ga4_page_product":[706],"ga4_page_region":[749],"ga4_page_therapeuticarea":[],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-105","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Clinical Efficacy Against Complicated Intra-Abdominal Infection (cIAI)<\/title>\n<meta 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