Data updated: May 26, 2026
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER (meropenem)
Infectious Disease
Approved 2015-04-30
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER is indicated for the treatment of Skin and Skin Structure Infections; Intra-abdominal Infections; Bacterial Meningitis.
Source: FDA Label • B BRAUN MEDICAL
How MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER Works
Meropenem is a bactericidal agent that inhibits bacterial cell wall synthesis. It penetrates the cell wall of most Gram-positive and Gram-negative bacteria to bind with high affinity to penicillin-binding proteins (PBPs). By binding to these targets, meropenem interferes with the transpeptidation of peptidoglycan chains, leading to cell wall instability and subsequent bacterial cell lysis.
1
Indication
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Phase 3 Trials
11
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-04-30
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2015 to 2024
Dec 2015 SUPPL
Mfg
What MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER Treats
3 indicationsMEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Skin and Skin Structure Infections
- Intra-abdominal Infections
- Bacterial Meningitis
Source: FDA Label
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER Competitive Set
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Clinical Trial Registry
61 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07556107 VPS | IRB00538615 BPS-2024C3-42018 | Ph 4 | not yet recruiting | The Vancomycin Piperacillin/Tazobactam (VPT) Patient Safety Trial (VPS) |
| NCT04983901 results posted | 2020-0074 NCI-2021-01957, 2020-0074 | Ph 2 | completed | PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN |
| NCT07445282 XDR-TY | 110/SZMC/SZH 110/SZMC/SZH | Ph 4 | completed | This Randomized Controlled Trial Evaluates the Comparative Efficacy of Intravenous Meropenem Alone Versus Intravenous Meropenem Combined With Oral Azithromycin in Children Aged 6 Months to Under 5 Years Diagnosed With Blood Culture-confirmed Extensively Drug-resistant Uncomplicated Typhoid Fever |
| NCT04478721 ASTARTÉ | ASTARTÉ 2020-000064-39 | Ph 3 | completed | Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins |
| NCT06916156 | ANT3310-1003 | Ph 1 | completed | Evaluation of the Concentration of ANT3310 and Meropenem in the Lung in Healthy Adult Participants |
| NCT04979806 | W-5222-301 | Ph 3 | completed | Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) |
| NCT03452839 MERCY | MERCY/9A/OSR 2016-002052-24 | Ph 4 | completed | Bolus Versus Continuous Infusion of Meropenem |
| NCT05922124 CASCADE | V0.1 May 2023 | Ph 4 | recruiting | Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii |
| NCT03671967 PETERPEN | MOH_2018-12-25_004857 | Ph 4 | recruiting | PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN) |
| NCT06527677 | ANT3310-1002 | Ph 1 | completed | Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects |
| NCT05355350 SPICE-M | 0295-18-RMB | Ph 4 | withdrawn | PipEracillin/Tazobactam Versus mERoPENem for Treatment of AmpC Producing Blood Stream Infections |
| NCT06184659 EMPRESS | RH-ITA-010 2023-509703-33-00 | Ph 4 | recruiting | Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis |
| NCT06168734 CERTAIN-2 | VNRX-5133-301 2022-502682-16 | Ph 3 | withdrawn | Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP |
| NCT03840148 CERTAIN-1 results posted | VNRX-5133-201 2018-001451-13 | Ph 3 | completed | Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections |
| NCT06342115 CLEMENT | CLEMENT TRIAL | Ph 4 | recruiting | Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens |
| NCT06841731 | HRS-8427-201 | Ph 2 | recruiting | A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia |
| NCT02820987 PAACS | 15/493 | Ph 3 | completed | PK/PD of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock |
| NCT03891433 CAPITIS | HUN-INF-CAPITIS-2018-1 | Ph 4 | suspended | Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic UTI Due to -ESBL-producing Enterobacteriaceae |
| NCT05784844 | IRB00088805 | Ph 4 | withdrawn | Antimicrobial Revision in Persistent Febrile Neutropenia |
| NCT05905913 | ANT3310-1001 | Ph 1 | completed | FiH Study to Assess Safety and PK of SAD and MAD of ANT3310 Alone and in Combination With Meropenem in Healthy Subjects |
| NCT06072222 | icu-22 | Ph 1, Ph 2 | completed | Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation |
| NCT06072248 | icu-23 | Ph 1, Ph 2 | completed | Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation |
| NCT02437045 MERINO II | HREC/14/QRBW/350 | Ph 4 | completed | Trial of Meropenem Versus Piperacillin-Tazobactam on Mortality and Clinial Response |
| NCT03230838 results posted | 7625A-034 2016-004153-32 | Ph 2 | completed | MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034) |
| NCT03217136 results posted | 7625A-035 MK-7625A-035, 2016-004820-41 | Ph 2 | completed | MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035) |
| NCT00621192 results posted | HHSN267200700051C HHSN267200700051C | Ph 1, Ph 2 | completed | Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections |
| NCT05565222 PITAGORE | APHP211034 | Ph 3 | recruiting | Piperacillin-tazobactam and Temocillin as Carbapenem-alternatives for the Treatment of Severe Infections Due to Extended-spectrum Beta-lactamase-Producing Gram-negative Enterobacteriaceae in the Intensive Care Unit |
| NCT03830333 7625ACNPhase3 results posted | 7625A-015 MK-7625A-015 | Ph 3 | completed | Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015) |
| NCT05226923 | KSP-1007-101 | Ph 1 | completed | Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects |
| NCT04876430 ABOVE | 2019-0401 | Ph 2, Ph 3 | terminated | Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems |
| NCT04553367 | ICU-40-20 | Ph 1, Ph 2 | completed | Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation |
| NCT04238390 MERINO III | UQCCR-DP-AS-2019-001 | Ph 3 | withdrawn | Ceftolozane-tazobactam Versus Meropenem for ESBL and AmpC-producing Enterobacterales Bloodstream Infection |
| NCT03485950 results posted | 2017-0729 NCI-2018-00755, 2017-0729 | Ph 2 | completed | Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam |
| NCT02784704 IGNITE4 results posted | TP-434-025 | Ph 3 | completed | Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections |
| NCT03032380 APEKS-NP results posted | 1615R2132 2016-003020-23 | Ph 3 | completed | Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens |
| NCT02070757 ASPECT-NP results posted | 7625A-008 CXA-NP-11-04, 163338 | Ph 3 | completed | Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008) |
| NCT02047773 BLTBrIV | BLTBrIVStudy | Ph 4 | completed | Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations |
| NCT03477422 PLEA | VRL/CSE-1034/05/2012 CTRI/2013/11/004133 | Ph 3 | completed | CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria |
| NCT01445678 results posted | 7625A-004 CXA-cIAI-10-09, CXA-cIAI-10-08 | Ph 3 | completed | Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections |
| NCT01970371 CARE results posted | ACHN-490-007 2013-001997-18, U1111-1151-2686 | Ph 3 | completed | A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE) |
| NCT02349841 | TASK-001 | Ph 2 | completed | Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Plus Amoxycillin/CA and Faropenem Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed Pulmonary Tuberculosis |
| NCT02486627 EPIC results posted | ACHN-490-009 2015-001588-37, U1111-1171-1554 | Ph 3 | completed | A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP) |
| NCT02475733 results posted | D4280C00015 C3591004, 2014-003242-28 | Ph 2 | completed | Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs). |
| NCT00752219 results posted | NXL-104/2002 C3591014 | Ph 2 | completed | Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections |
| NCT03174795 | NP39596 2016-004478-16 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection |
| NCT03182504 | NP39750 2016-004478-16 | Ph 1 | completed | A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants |
| NCT01429259 results posted | KUTI003498HE | Ph 4 | completed | Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children |
| NCT01381562 results posted | 114689 | Ph 2 | terminated | GSK2251052 in the Treatment of Complicated Intra-abdominal Infections |
| NCT02176122 MERINO | ACTRN12613000532707 | Ph 4 | terminated | RCT Meropenem vs Piperacillin-Tazobactam for Definitive Treatment of BSI's Due to Ceftriaxone Non-susceptible Escherichia Coli and Klebsiella Spp. |
| NCT01726023 RECLAIM3 results posted | D4280C00018 2011-003893-97 | Ph 3 | completed | Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections |
Showing 50 of 61 trials
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER is indicated for the treatment of Skin and Skin Structure Infections; Intra-abdominal Infections; Bacterial Meningitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.