CLINICAL TRIALS PROFILE FOR MEROPENEM

All Clinical Trials for meropenem

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00307099 ↗	Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2006-10-01	This study will enroll 460 subjects who have new pulmonary infiltrates during their ICU stay and who are at low risk of having pneumonia, as determined using the Clinical Pulmonary Infection Score (CPIS). The study is designed to determine whether 3 days of antibiotic treatment with meropenem (with or without coverage for MRSA) for ICU subjects diagnosed with new pulmonary infiltrates can reduce the emergence of anti-microbial-resistant organisms and the isolation of a potential pathogen compared to a standard course of antibiotic therapy (minimum of 8 days of therapy with antibiotics of the primary care team's choosing). Subjects will be randomly placed in either the meropenem group or standard antibiotic therapy group. The study will also examine whether short-course therapy reduces hospital length of stay and hospital cost, without having a negative effect on subject morbidity and mortality.
NCT00130754 ↗	Thymoglobuline in Non-myeloablative Allogeneic Stem-cell Transplantation	Completed	Hadassah Medical Organization	Phase 3	2005-02-01	Allogeneic stem cell transplantation is the treatment of choice for a growing number of malignant and non-malignant indications. Until recently, myeloablative in conjunction with immunosuppressive conditioning was considered mandatory for the elimination of malignant hematopoietic cells and to prevent graft rejection. The aim of allogeneic non-myeloablative stem cell transplantation (NST) is to induce host-to-graft tolerance with fast and durable engraftment of donor stem cells, by means of conditioning, which is well-tolerated by patients. The rationale behind the NST strategy is to induce optimal graft-versus-leukemia (GVL) effects for the elimination of all malignant cells by alloreactive immunocompetent cells from a matched donor as an alternative to standard high-dose myeloablative chemo radiotherapy. The NST protocol is therefore mainly based on immunosuppression and thus contains fludarabine, low dose busulfan and anti-T-lymphocyte globulin (ATG). Thymoglobuline is a polyclonal rabbit antiserum specific for human T cells used in organ transplantation for induction of tolerance and rejection prevention and treatment. It was also used in stem-cell transplantation (SCT) for the same purposes (e.g. for generation of tolerance and rejection preclusion) as well as a treatment for graft-versus-host disease (GVHD). Data from myeloablative protocols suggest that ATG before SCT significantly reduces the risk for grade III-IV acute GVHD. This does not translate to a reduction in transplant-related mortality (TRM) because of the increased risk for infections and thus survival is unchanged. Extensive chronic GVHD was also significantly shown to be reduced in patients receiving ATG in the myeloablative setting. However, the role of ATG in the NST protocol was never evaluated in a prospective randomized trial. In view of the preliminary data suggesting of an additive effect of ATG in these circumstances we, the investigators at Hadassah Medical Organization, evaluate the effect of ATG in NST by a prospective randomized trial.
NCT00061438 ↗	A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died	Completed	AstraZeneca	Phase 4	2003-02-01	This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems. It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful. This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication). Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis. It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis. Approximately 240 patients will take part in this study. Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.
NCT00061438 ↗	A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died	Completed	Pfizer	Phase 4	2003-02-01	This is a research study in patients having a condition known as necrotizing pancreatitis. This is inflammation of the pancreas (an intestinal organ which assists with digestion) that has resulted in the damage and death of some pancreatic tissue. This damaged pancreatic tissue may develop a bacterial infection, which can cause further -sometimes very serious- health problems. It may be possible to prevent or delay infection by giving 'prophylactic' antibiotics (that is - to provide protection before any infection starts). However, it is not certain that this antibiotic therapy will be successful. This study is being carried out to see whether the antibiotic 'Meropenem' (which is also known as MERREM I.V.) provides protection from developing a pancreatic infection. This will be done by comparing the progress of patients who receive meropenem with those who receive a non-active placebo solution (a solution that does not contain any active medication). Meropenem or placebo would be given in addition to the standard treatment received for pancreatitis. It is not known if meropenem will help prevent infections associated with necrotizing pancreatitis. Approximately 240 patients will take part in this study. Study participation will be carried out for up to 6 weeks, and patients will receive the study treatment up to a maximum of 21 days.
NCT00050401 ↗	Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support	Completed	AstraZeneca	Phase 3	2002-07-01	The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
NCT00050401 ↗	Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support	Completed	Pfizer	Phase 3	2002-07-01	The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
NCT00318552 ↗	Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.	Completed	AstraZeneca	Phase 4	2002-01-01	This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.

Clinical Trial Conditions for meropenem

Condition Name

Condition Name for meropenem
Intervention	Trials
Sepsis	11
Acute Pyelonephritis	8
Septic Shock	8
Bacteremia	6

Condition MeSH

Condition MeSH for meropenem
Intervention	Trials
Infections	48
Infection	40
Communicable Diseases	39
Sepsis	23

Clinical Trial Locations for meropenem

Trials by Country

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Trials by Country for meropenem
Location	Trials
United States	215
China	54
Spain	47
Italy	29
India	26

Trials by US State

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−

Trials by US State for meropenem
Location	Trials
California	19
Ohio	18
Florida	16
New York	15
Illinois	12

Clinical Trial Progress for meropenem

Clinical Trial Phase

Clinical Trial Phase for meropenem
Clinical Trial Phase	Trials
Phase 4	36
Phase 3	40
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for meropenem
Clinical Trial Phase	Trials
Completed	66
Not yet recruiting	22
Recruiting	19

Clinical Trial Sponsors for meropenem

Sponsor Name

Sponsor Name for meropenem
Sponsor	Trials
Pfizer	12
AstraZeneca	10
Merck Sharp & Dohme Corp.	8

Sponsor Type

Sponsor Type for meropenem
Sponsor	Trials
Other	161
Industry	79
U.S. Fed	8

Meropenem: Clinical Trials, Market Analysis, and Projections

Introduction

Meropenem, a broad-spectrum β-lactam antibiotic, is widely used in the treatment of severe infections, including sepsis and nosocomial pneumonia. This article provides an update on recent clinical trials, market analysis, and future projections for meropenem.

Clinical Trials Update

Continuous vs Intermittent Administration

A significant clinical trial, the MERCY study, investigated the efficacy of continuous versus intermittent administration of meropenem in critically ill patients with sepsis or septic shock. This double-blind, randomized clinical trial, involving 607 patients across 31 intensive care units in four countries, found that continuous administration of meropenem did not improve clinically relevant outcomes compared to intermittent administration. The study reported no significant difference in the composite outcome of all-cause mortality and the emergence of pandrug-resistant or extensively drug-resistant bacteria at day 28[1].

Therapeutic Drug Monitoring (TDM)

Another study highlighted the importance of TDM in optimizing meropenem dosing. This retrospective study used software-guided empiric dosing and TDM to adjust meropenem doses, ensuring therapeutic concentrations without exceeding toxic levels. The study demonstrated that TDM-guided dose adjustments, interpreted by trained clinical pharmacists, can achieve higher target achievements and avoid potentially harmful concentrations[3].

Market Analysis

Global Market Trends

The global meropenem injection market is expected to grow, driven by increasing demand for effective antibacterial drugs. The market size in 2023 was significant, with a projected compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented by type, application, and region, with North America, Europe, Asia Pacific, Middle East & Africa, and Latin America being the major regions[5].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the meropenem market, particularly in China. The sales revenue of meropenem in China decreased by 12.2% in 2020 due to the pandemic's effect on hospital operations. However, as the epidemic situation improved, the market is expected to recover and grow from 2021 to 2025[2].

Competitive Landscape

The meropenem market is competitive, with several key manufacturers. In China, companies like Sumitomo Dainippon Pharma Co Ltd, Shenzhen Haibin Pharmaceutical Co., Ltd., and CSPC Ouyi Pharmaceutical Group Co., Ltd. are major players. These companies have significant market shares in terms of sales value and volume[2].

Market Projections

Revenue Growth

The global meropenem injection market is forecasted to experience revenue growth from 2024 to 2031. This growth is driven by increasing demand for effective antibiotics, especially in regions with high incidence rates of severe infections. The market report provides detailed insights into regional and country-level trends, helping to understand the future prospects of the meropenem injection market[5].

Regional Analysis

The market is segmented into five major regions: North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own growth rate and market dynamics, influenced by factors such as healthcare infrastructure, regulatory policies, and disease prevalence. The Asia Pacific region, particularly China, is expected to show significant growth due to the recovery from the COVID-19 pandemic and the increasing demand for antibacterial drugs[5].

Application and Type Analysis

Meropenem is used in various applications, including the treatment of nosocomial pneumonia, sepsis, and other severe infections. The market analysis also segments meropenem by type, such as injections, and other dosage forms. Understanding these segments helps in identifying the most lucrative areas for future growth and investment[5].

Efficacy and Tolerability

Clinical Efficacy

Meropenem has shown efficacy in clinical trials as an initial empirical therapy for the treatment of nosocomial pneumonia and other severe infections. Its broad-spectrum activity makes it a valuable option in intensive care settings[4].

Safety Profile

Meropenem is generally well-tolerated, with a safety profile that includes minimal adverse events such as seizures or allergic reactions. The MERCY study reported no such adverse events related to the study drug[1].

Key Takeaways

• Clinical Trials: Continuous administration of meropenem does not improve clinically relevant outcomes compared to intermittent administration in critically ill patients.
• Market Trends: The global meropenem market is expected to grow, driven by increasing demand for effective antibacterial drugs.
• COVID-19 Impact: The pandemic affected the meropenem market in China, but the market is expected to recover and grow.
• Regional Growth: Asia Pacific, particularly China, is expected to show significant growth.
• Efficacy and Safety: Meropenem is effective and well-tolerated, making it a valuable option in intensive care settings.

FAQs

What is the current consensus on the administration of meropenem in critically ill patients?

The MERCY study indicates that continuous administration of meropenem does not improve clinically relevant outcomes compared to intermittent administration in critically ill patients with sepsis or septic shock[1].

How has the COVID-19 pandemic impacted the meropenem market in China?

The COVID-19 pandemic led to a 12.2% decrease in meropenem sales revenue in China in 2020. However, the market is expected to recover and grow as the epidemic situation improves[2].

What are the key applications of meropenem?

Meropenem is primarily used in the treatment of nosocomial pneumonia, sepsis, and other severe infections[4].

What is the role of Therapeutic Drug Monitoring (TDM) in meropenem dosing?

TDM is crucial in optimizing meropenem doses to ensure therapeutic concentrations without exceeding toxic levels, especially in patients with varying renal function[3].

What are the projections for the global meropenem injection market?

The global meropenem injection market is forecasted to experience revenue growth from 2024 to 2031, driven by increasing demand for effective antibacterial drugs[5].

Sources

1. JAMA Network: Continuous vs Intermittent Meropenem Administration in Critically Ill Patients with Sepsis or Septic Shock.
2. Research and Markets: Investigation Report on China's Meropenem Market 2021-2025.
3. MDPI: Software- and TDM-Guided Dosing of Meropenem Promises High Target Achievements.
4. Oxford Academic: Update on the Efficacy and Tolerability of Meropenem in the Treatment of Nosocomial Pneumonia.
5. Cognitive Market Research: Meropenem Injection Market Report 2024 (Global Edition).