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Effect of Meropenem-Vaborbactam Vs Piperacillin-Tazobactam on Clinical

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Effect of Meropenem-Vaborbactam Vs Piperacillin-Tazobactam on Clinical Supplementary Online Content 1 Kaye KS, Bhowmick T, Metallidis S, et al. Effect of meropenem- vaborbactam vs piperacillin-tazobactam on clinical cure or improvement and microbial eradication in complicated urinary tract infection. JAMA. doi:10.1001/jama.2018.0438 Study Protocol Downloaded From: https://jamanetwork.com/ on 09/29/2021 Clinical Study Protocol A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF CARBAVANCE (MEROPENEM/RPX7009) COMPARED TO PIPERACILLIN/TAZOBACTAM IN THE TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING ACUTE PYELONEPHRITIS, IN ADULTS Protocol Number: REMPEX-505 Amended Protocol Dated: 14 JAN 2016, Version 4.0 Amended Protocol Dated: 02 APR 2015, Version 3.0 Amended Protocol Dated: 06 AUG 2014, Version 2.0 Original Protocol Dated: 06 MAY 2014, Version 1.0 Phase 3 Investigational Product Carbavance™ (Meropenem/RPX7009) US IND # 120040 EudraCT #2014-000545-78 Rempex Pharmaceuticals, a wholly-owned subsidiary of Sponsor: Rempex Pharmaceuticals, Inc. A wholly owned subsidiary of The Medicines Company 8 Sylvan Way Parsippany, NJ 07054 GCP Statement This study is to be performed in full compliance with the protocol, Good Clinical Practices (GCP), and applicable regulatory requirements. All required study documentation will be archived as required by regulatory authorities. Confidentiality Statement This document is confidential. It contains proprietary information belonging to Rempex Pharmaceuticals, Inc. (Rempex). Any viewing or disclosure of such information that is not authorized in writing by Rempex is strictly prohibited. Such information may be used solely for the purpose of reviewing or performing this study. Downloaded From: https://jamanetwork.com/ on 09/29/2021 REMPEX PHARMACEUTICALS, INC. Carbavance™ (Meropenem/RPX7009) CONFIDENTIAL Clinical Study Protocol: REMPEX-505 1 PROTOCOL REVISION HISTORY Date/Version Description 0$<9HUVLRQ 2ULJLQDOSURWRFRO $8*9HUVLRQ $PHQGHGSURWRFRO $359HUVLRQ $PHQGHGSURWRFRO -$19HUVLRQ $PHQGHGSURWRFRO -$19HUVLRQ 4.0 3DJHRI Downloaded From: https://jamanetwork.com/ on 09/29/2021 REMPEX PHARMACEUTICALS, INC. Carbavance™ (Meropenem/RPX7009) CONFIDENTIAL Clinical Study Protocol: REMPEX-505 2 SPONSOR SIGNATURE A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy Study to Evaluate the Efficacy, Safety, and Tolerability of Carbavance (Meropenem/RPX7009) Compared to Piperacillin/Tazobactam in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, in Adults Sponsor 5HPSH[3KDUPDFHXWLFDOV,QF 6\OYDQ:D\ 3DUVLSSDQ\1- Sponsor Representative -HIIHU\/RXWLW0%&K% 9LFH3UHVLGHQWDQG&KLHI0HGLFDO2IILFHU 5HPSH[ &HOO )D[ HPDLOMHIIORXWLW#WKHPHGFRFRP -$1 6LJQDWXUH 'DWH -$19HUVLRQ 4.0 3DJHRI Downloaded From: https://jamanetwork.com/ on 09/29/2021 REMPEX PHARMACEUTICALS, INC. 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