MedPath

Meropenem

Generic Name
Meropenem
Brand Names
Vabomere
Drug Type
Small Molecule
Chemical Formula
C17H25N3O5S
CAS Number
96036-03-2
Unique Ingredient Identifier
YOP6PX0BAO
Background

Meropenem is a broad-spectrum carbapenem antibiotic. It is active against Gram-positive and Gram-negative bacteria. Meropenem exerts its action by penetrating bacterial cells readily and interfering with the synthesis of vital cell wall components, which leads to cell death.

In August 2017, a combination antibacterial therapy under the market name vabomere was approved for treatment of adult patients with complicated urinary tract infections (cUTI). Vabomere consists of meropenem and Vaborbactam and is intravenously admininstered. The treatment aims to resolve infection-related symptoms and achieve negative urine culture, where the infections are proven or strongly suspected to be caused by susceptible bacteria.

Indication

For use as single agent therapy for the treatment of the following infections when caused by susceptible isolates of the designated microorganisms: complicated skin and skin structure infections due to Staphylococcus aureus (b-lactamase and non-b-lactamase producing, methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (excluding vancomycin-resistant isolates), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis and Peptostreptococcus species; complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species. Also for use in the treatment of bacterial meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (b-lactamase and non-b-lactamase-producing isolates), and Neisseria meningitidis.

Associated Conditions
Bacterial Infections, Complicated Intra-Abdominal Infections (cIAIs), Meningitis, Bacterial, Complicated Urinary Tract Infection caused by susceptible bacteria, Complicated skin infection bacterial

To Evaluate the Pharmacokinetic Effects of TQD3606 for Injection in Healthy Adult Subjects

Phase 1
Conditions
Infections
Interventions
Drug: The injectable TQD3606
Drug: Placebo
First Posted Date
2022-04-22
Last Posted Date
2022-04-22
Lead Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Target Recruit Count
56
Registration Number
NCT05340530
Locations
🇨🇳

Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun, Jilin, China

Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects

Phase 1
Completed
Conditions
Bacterial Infections
Interventions
First Posted Date
2022-02-07
Last Posted Date
2022-10-27
Lead Sponsor
Sumitovant Biopharma, Inc.
Target Recruit Count
123
Registration Number
NCT05226923
Locations
🇺🇸

PRA Health Sciences, Lenexa, Kansas, United States

Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)

Phase 3
Not yet recruiting
Conditions
Complicated Urinary Tract Infection Including Acute Pyelonephritis
Interventions
Drug: Combination of Imipenem/Cilastatin and XNW4107
First Posted Date
2022-01-24
Last Posted Date
2023-02-16
Lead Sponsor
Evopoint Biosciences Inc.
Target Recruit Count
780
Registration Number
NCT05204368
Locations
🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

Pharmacokinetics of Piperacillin and Meropenem in ICU Patients

Conditions
Antibiotic Pharmacokinetics
Interventions
First Posted Date
2021-11-24
Last Posted Date
2021-11-24
Lead Sponsor
Karolinska University Hospital
Target Recruit Count
50
Registration Number
NCT05134298
Locations
🇸🇪

Karolinska University Hospital, Stockholm, Sweden

Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: FL058 1000mg and Meropenem 2000mg ( IV 120min)
Drug: FL058 1000mg and Meropenem 2000mg ( IV 180min)
Drug: FL058 1000mg( IV 120min)
Drug: FL058 500mg and Meropenem 1000mg( IV 120min)
Drug: FL058 2000mg and Meropenem 2000mg( IV 180min)
Drug: FL058 Placebo and Meropenem 2000m( IV 180min)
Drug: FL058 Placebo and Meropenem 1000mg( IV 120min)
Drug: FL058 Placebo ( IV 120min)
Drug: FL058 Placebo and Meropenem 2000m( IV 120min)
Drug: FL058 Placebo and Meropenem 2000mg( IV 180min)
Drug: FL058 1000mg and Meropenem 1000mg ( IV 120min)
Drug: FL058 Placebo and Meropenem 1000mg ( IV 120min)
First Posted Date
2021-09-27
Last Posted Date
2021-09-27
Lead Sponsor
Qilu Pharmaceutical Co., Ltd.
Target Recruit Count
40
Registration Number
NCT05058105
Locations
🇨🇳

Huashan Hospital affiliated to Fudan University, Shanghai, China

PK of Meropenem in Patients on Plasma Exchange

Conditions
Autoimmune Diseases
Interventions
First Posted Date
2021-09-13
Last Posted Date
2021-09-13
Lead Sponsor
Prince of Songkla University
Target Recruit Count
15
Registration Number
NCT05042271
Locations
🇹🇭

Faculty of Medicine, Prince of Songkla University, Thailand, Hat Yai, Songkla, Thailand

PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN

Phase 2
Completed
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Interventions
First Posted Date
2021-07-30
Last Posted Date
2024-11-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
100
Registration Number
NCT04983901
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Phase 3
Completed
Conditions
Complicated Urinary Tract Infection
Acute Pyelonephritis
Interventions
Drug: Cefepime-zidebactam (FEP-ZID)
First Posted Date
2021-07-28
Last Posted Date
2025-02-07
Lead Sponsor
Wockhardt
Target Recruit Count
530
Registration Number
NCT04979806
Locations
🇧🇬

Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov, Sofia, Bulgaria

🇲🇽

Centro de Investigacion Clinica de Oaxaca (CICLO), Oaxaca, Mexico

🇲🇽

Pharmacology & Clinical Research, Queretaro Qro, Mexico

and more 45 locations

Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems

Phase 2
Terminated
Conditions
Carbapenem-Resistant Enterobacteriaceae Infection
Bloodstream Infection
Interventions
First Posted Date
2021-05-06
Last Posted Date
2022-08-03
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
13
Registration Number
NCT04876430
Locations
🇧🇷

Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil

🇧🇷

Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

Antibiotics Continuous Infusion at Home

Phase 1
Conditions
Severe Bacterial Infections
Interventions
First Posted Date
2021-03-25
Last Posted Date
2021-03-25
Lead Sponsor
Ospedale San Carlo Borromeo
Target Recruit Count
50
Registration Number
NCT04816968
Locations
🇮🇹

ASST Santi Paolo Carlo - San Carlo Borromeo Hospital - SSd Onco-Hematology, Milan, Italy

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