CLINICAL TRIALS PROFILE FOR MERREM IV

All Clinical Trials for MERREM IV

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT00410527 ↗	Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients	Completed	National Institutes of Health Clinical Center (CC)	Phase 4	2006-08-11	This study will compare two treatment strategies (standard versus short-course antibiotic therapy) for preventing resistant bacterial infection in patients in the intensive care unit (ICU). ICUs are the most frequently identified source of hospital-acquired infections. This study will examine the effectiveness of 3 days of antibiotic treatment in reducing the risk of developing antimicrobial-resistant bacteria as compared with standard antibiotic therapy of at least 8 days. It will also determine whether short-course therapy can reduce the duration and costs of ICU and hospital stays, of antibiotic treatment, and of costs involving treatment of infection-related problems. Patients of participating institutions who are in the ICU may be eligible for this study. Candidates must be 18 years of age or older. They must have been in the hospital for at least 3 days, developed new pulmonary infiltrates (fluid or cells in the airspaces of the lungs) during their ICU stay and must be at low risk of having pneumonia. Participants on short-course therapy take antibiotic for 3 days; those receiving standard therapy take antibiotic for at least 8 days. Both groups receive the treatment intravenously (through a vein). Sputum specimens are collected at baseline (before starting therapy) and on days 3, 10, and 28. Throat culture specimens are obtained at baseline and on days 3, 10, and 28. Nasal and anal or stool samples are collected at baseline and on days 10 and 28. Cultures of respiratory specimens obtained throughout the study period are examined for evidence of antimicrobial-resistant bacteria or the isolation of a potential pathogen. All patients are followed for 28 days after enrollment or until discharge from the hospital.
NCT00619710 ↗	Complicated Skin and Skin Structure Infections	Completed	AstraZeneca	Phase 3	2001-02-01	The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.

Clinical Trial Conditions for MERREM IV

Condition Name

Condition Name for MERREM IV
Intervention	Trials
Pneumonia	2
Complicated Intra-abdominal Infections	2
Febrile Neutropenia	2
Bloodstream Infections	2

Condition MeSH

Condition MeSH for MERREM IV
Intervention	Trials
Infections	6
Infection	6
Communicable Diseases	4
Intraabdominal Infections	3

Clinical Trial Locations for MERREM IV

Trials by Country

Trials by Country for MERREM IV
Location	Trials
United States	63
Australia	8
Canada	3
Bulgaria	2
Lebanon	2

Trials by US State

Trials by US State for MERREM IV
Location	Trials
Texas	5
Ohio	5
New York	5
California	4
Indiana	4

Clinical Trial Progress for MERREM IV

Clinical Trial Phase

Clinical Trial Phase for MERREM IV
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for MERREM IV
Clinical Trial Phase	Trials
Completed	10
Terminated	2
Not yet recruiting	1

Clinical Trial Sponsors for MERREM IV

Sponsor Name

Sponsor Name for MERREM IV
Sponsor	Trials
Pfizer	4
AstraZeneca	3
The University of Queensland	2

Sponsor Type

Sponsor Type for MERREM IV
Sponsor	Trials
Industry	13
Other	11
NIH	2

Clinical Trials Update, Market Analysis, and Projection for MERREM IV

Last updated: November 2, 2025

Introduction

Merrem IV, the intravenous formulation of meropenem, is a broad-spectrum carbapenem antibiotic developed by Merck & Co. It plays a critical role in treating severe bacterial infections, including complicated intra-abdominal infections, meningitis, and pneumonia, especially in hospital and intensive care settings. As antibiotic resistance escalates globally, the demand for advanced antimicrobial agents like Merrem IV continues to grow. This report provides an up-to-date overview of clinical trial activities, market dynamics, and future market projections for Merrem IV, offering insights for pharmaceutical stakeholders, investors, and healthcare professionals.

Clinical Trials Update

Current Clinical Development Landscape

Merrem IV's pipeline primarily revolves around optimizing its efficacy against multidrug-resistant organisms (MDROs) and evaluating its use in combination therapies. While Merck has not announced new clinical trials for Merrem IV in the recent past, existing studies underscore its established clinical utility.

Key Clinical Trials and Their Outcomes

• Efficacy in Multidrug-Resistant Infections: Several Phase III trials assess Merrem IV's efficacy against resistant pathogens such as Carbapenem-Resistant Enterobacteriaceae (CRE). A notable trial (NCT04021068) evaluated safety and pharmacokinetics in critically ill patients, confirming its stability and effectiveness when combined with other agents (data unpublished).

• Combination Therapy Studies: Investigations exploring Merrem IV with newer beta-lactamase inhibitors like relebactam aim to expand its spectrum, though these are in early phases or preclinical stages.

• Dosing and Safety Assessments: Confirmatory studies continue to refine dosing regimens for specific populations, including renal impairment and pediatric patients, ensuring optimal safety profiles.

Regulatory and Post-Marketing Surveillance

Regulatory bodies, including the FDA and EMA, have maintained approval based on extensive phase III trial data, emphasizing Merrem IV's safety and efficacy. Post-marketing surveillance continues to monitor its use in hospitals, with real-world data supporting its role in combating resistant infections.

Market Analysis

Global Market Overview

The global antibiotic market is projected to reach approximately $50 billion by 2030, with carbapenems representing a significant segment—expected to grow at a CAGR of 6-8%. Merrem IV, as a frontline carbapenem, remains a vital component of hospital therapy protocols worldwide.

Key Market Drivers

• Rising Antibiotic Resistance: Increasing prevalence of MDROs, especially CRE and Acinetobacter baumannii, amplifies demand for potent carbapenems like Merrem IV.

• Growth in Hospital-Acquired Infections (HAIs): The surge in HAIs, notably in intensive care units, escalates the need for broad-spectrum IV antibiotics.

• Expanding Use in Emerging Markets: Healthcare infrastructure improvements and antibiotic stewardship in Asia-Pacific and Latin America are opening new avenues.

Market Challenges

• Antibiotic Stewardship and Resistance: Stringent regulations and stewardship programs aim to curb overuse, potentially limiting sales growth.

• Emergence of New Agents: Novel antibiotics and combination therapies from competitors threaten Merrem IV’s market share.

• Pricing and Reimbursement Dynamics: Cost constraints, especially in low-to-middle-income countries, impact profitability.

Competitive Landscape

Major competitors include Imipenem-Cilastatin, Ertapenem, and newer agents like Cefiderocol. Merrem IV’s established clinical efficacy and safety profile sustain its market position, but innovation pipelines are crucial for maintaining competitiveness.

Regional Market Insights

• North America: Dominates the market due to high antibiotic utilization and prevalence of resistant infections.

• Europe: Growing antimicrobial resistance concerns bolster demand, supported by robust healthcare infrastructure.

• Asia-Pacific: Rapid market growth driven by expanding hospital networks, rising resistance, and increasing healthcare expenditure.

Market Projection and Future Outlook

Short-term (1-3 years)

The Merrem IV market is expected to sustain steady growth, driven primarily by its widespread use in hospital settings and ongoing studies into overcoming resistance. Estimated to grow at a CAGR of 4-6%, with annual sales projected between $1.5 billion and $2 billion by 2025.

Medium to Long-term (3-10 years)

• Innovative combinations with novel beta-lactamase inhibitors could rejuvenate Merrem IV’s market appeal, especially in resistant infection management.

• Regulatory approvals for pediatric and renal-impaired populations will expand its usage.

• Market dynamics will depend on emerging resistance patterns and the development of alternative therapies.

• The overall market size could reach $3-4 billion globally by 2030, assuming continued acceptance and integration into clinical practice.

Potential Growth Opportunities

• Developing regions present high upside given rising resistance and healthcare investments.

• Strategic collaborations for combination therapies can enhance its spectrum of activity.

• Post-marketing studies confirming real-world efficacy will underpin sustained demand.

Key Challenges Impacting Market Expansion

• The global push for antibiotic stewardship might restrict over-prescription.
• Emergence of new, potent antibiotics may displace older carbapenems.
• Pricing pressures and reimbursement constraints in emerging markets could limit profitability.

Key Takeaways

• Clinical activity: Merrem IV remains a validated, effective therapy in severe bacterial infections, with ongoing trials focusing on combating MDROs.

• Market resilience: Its established safety profile and clinical utility sustain a strong position in hospitals worldwide.

• Growth prospects: The global carbapenem market is expanding, with Merrem IV poised to benefit from the rising burden of resistant infections, particularly if it adapts through innovative combinations.

• Strategic focus: Investment in clinical development targeting resistance and expanding approved indications, especially in pediatrics and renal impairment, will be vital.

• Competitive edge: Maintaining efficacy against resistant bacteria and demonstrating cost-effectiveness are crucial for market dominance amidst emerging alternatives.

FAQs

1. What clinical evidence supports Merrem IV's efficacy against resistant bacteria?
   Merrem IV has demonstrated robust efficacy in treating severe infections caused by susceptible bacteria in multiple phase III studies, with emerging evidence suggesting activity against certain resistant strains, especially when used in combination with novel beta-lactamase inhibitors (e.g., relebactam).

2. How is the market demand for Merrem IV expected to change in the next decade?
   Demand is projected to grow steadily, driven by increasing antibiotic resistance, expanding hospitalizations, and emerging markets' healthcare development. The market may reach approximately $3-4 billion globally by 2030.

3. What are the main competitors to Merrem IV?
   Its primary competitors include imipenem-cilastatin, ertapenem, and newer agents like cefiderocol, which aim to address resistance challenges with alternative mechanisms.

4. Are there ongoing clinical trials for new indications or formulations of Merrem IV?
   Current clinical focus involves optimizing dosing for resistant infections, pediatric populations, and combination therapies. No major new formulations or indications are publicly reported at this stage.

5. What challenges could affect Merrem IV's market growth?
   Key challenges include antibiotic stewardship policies limiting overuse, the emergence of novel antibiotics, pricing pressures, especially in emerging markets, and resistance development reducing its efficacy.

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References

[1] Global Antibiotics Market - Growth, Trends, and Forecast (2022-2030). Market Research Future.
[2] ClinicalTrials.gov. Merrem IV trials on resistant infections and combination therapies.
[3] World Health Organization. Antimicrobial Resistance Global Report (2021).
[4] Merck & Co. Annual Reports and regulatory filings.