CLINICAL TRIALS PROFILE FOR ERYTHROMYCIN LACTOBIONATE

All Clinical Trials for ERYTHROMYCIN LACTOBIONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04066231 ↗	ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model	Terminated	Prof Dr Jan Tack	N/A	2019-09-07	It has been demonstrated that the VIPUN Gastric Monitoring System (GMS) can discriminate healthy physiological and pharmacologically-inhibited gastric motility, using a codeine-model in healthy adults (S60320 / AFMPS80M0687). Erythromycin is a gastroprokinetic agent, known to stimulate gastric contractility. A single dose of 200 mg erythromycin has been shown to induce a prolonged period of enhanced phasic contractile activity. The primary aim of this investigation is to validate the ability of the VIPUN GMS to discriminate between normal and pharmacologically-enhanced fasting gastric motility in healthy adults. The performance of the VIPUN GMS can be enhanced by data-driven optimization of the VIPUN Motility Algorithm, used to quantify gastric motility.
NCT02605122 ↗	Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia	Terminated	Biomedical Advanced Research and Development Authority	Phase 2/Phase 3	2016-04-01	This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
NCT02605122 ↗	Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia	Terminated	Cempra Inc	Phase 2/Phase 3	2016-04-01	This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
NCT02605122 ↗	Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia	Terminated	Melinta Therapeutics, Inc.	Phase 2/Phase 3	2016-04-01	This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
NCT02633579 ↗	Effect of the Motilin Receptor Agonist, Erythromycin, on Hunger and Food Intake; Study of Role of Cholinergic Pathways	Completed	Universitaire Ziekenhuizen Leuven	N/A	2012-10-01	In this study, the investigators will evaluate if the food intake associated with the infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown effect of erythromycin. To obtain this the investigators will use atropine, a muscarinic receptor antagonist, to inhibit the formation of contractions induced by a low dose of erythromycin
NCT02755064 ↗	Relationship Between Gastric Emptying and Glycemic Variability in Type 1 Diabetes Mellitus	Completed	Adil Bharucha	Phase 1	2010-06-01	With this study, the investigators hoped to learn if the rate at which food empties from the stomach affects blood sugar values. Using data from this study, we hope to improve our ability to control blood sugars in individuals with type 1 diabetes mellitus.
NCT00034736 ↗	A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2002-08-01	The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.

Clinical Trial Conditions for ERYTHROMYCIN LACTOBIONATE

Condition Name

Condition Name for ERYTHROMYCIN LACTOBIONATE
Intervention	Trials
Healthy	1
Pneumonia	1
Community-acquired Bacterial Pneumonia	1
Diabetes Mellitus, Type 1	1

Condition MeSH

Condition MeSH for ERYTHROMYCIN LACTOBIONATE
Intervention	Trials
Pneumonia	2
Diabetes Mellitus, Type 1	1
Diabetes Mellitus	1
Pneumonia, Bacterial	1

Clinical Trial Locations for ERYTHROMYCIN LACTOBIONATE

Trials by Country

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−

Trials by Country for ERYTHROMYCIN LACTOBIONATE
Location	Trials
United States	15
Spain	3
Belgium	1
Philippines	1
Hungary	1

Trials by US State

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−

Trials by US State for ERYTHROMYCIN LACTOBIONATE
Location	Trials
Minnesota	1
Virginia	1
Texas	1
Tennessee	1
Pennsylvania	1

Clinical Trial Progress for ERYTHROMYCIN LACTOBIONATE

Clinical Trial Phase

Clinical Trial Phase for ERYTHROMYCIN LACTOBIONATE
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for ERYTHROMYCIN LACTOBIONATE
Clinical Trial Phase	Trials
Completed	3
Terminated	2

Clinical Trial Sponsors for ERYTHROMYCIN LACTOBIONATE

Sponsor Name

Sponsor Name for ERYTHROMYCIN LACTOBIONATE
Sponsor	Trials
Biomedical Advanced Research and Development Authority	1
Cempra Inc	1
Melinta Therapeutics, Inc.	1

Sponsor Type

Sponsor Type for ERYTHROMYCIN LACTOBIONATE
Sponsor	Trials
Other	3
Industry	3
U.S. Fed	1

Erythromycin Lactobionate: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Gastric Emptying in Emergency Surgery

One of the notable clinical trials involving erythromycin lactobionate is the Erythro-Emerge trial. This single-center, randomized, double-blinded, placebo-controlled clinical trial was conducted at Geneva University Hospitals to evaluate the efficacy of erythromycin lactobionate in enhancing gastric emptying among patients undergoing emergency surgery under general anesthesia.

• Design and Participants: The trial included 132 patients, randomized to receive either intravenous erythromycin lactobionate (3 mg/kg) or a placebo 15 minutes before tracheal intubation. Patients were followed up for 24 hours and stratified into trauma and nontrauma populations[1].
• Outcomes: The primary outcome was a clear stomach, defined as less than 40 mL of liquids and no solids, identified through endoscopy immediately after intubation. The results showed that 80% of patients receiving erythromycin had a clear stomach compared to 64% of those receiving the placebo, indicating a significant increase in gastric emptying with erythromycin administration[1].

Market Analysis

Current Market Size and Growth

The erythromycin lactobionate market is part of the broader erythromycin market, which has been experiencing steady growth.

• Market Value: As of 2023, the global erythromycin market was valued at USD 15.3 billion and is projected to reach USD 26.0 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period from 2024 to 2033[5].
• Segment Analysis: The market is segmented by product type, application, and geography. Erythromycin tablets lead the market, widely used for their effectiveness, while respiratory tract infections account for a significant portion of the applications due to high incidence rates[5].

Key Players and Regions

• Major Players: Companies such as Cambrex Corporation, Simagchem Corporation, Ningbo Hi-Tech Biochemicals Co., Ltd., Medilink Pharmachem, and AdvaCare are prominent in the erythromycin lactobionate market[2].
• Geographical Distribution: The market is predominantly driven by regions such as North America, Europe, China, Japan, India, and Southeast Asia. North America leads the market due to high healthcare spending and advanced medical infrastructure[2][5].

Market Projections and Growth Opportunities

Expansion in Emerging Markets

• Growing Healthcare Access: Emerging markets, particularly countries like India, offer significant growth opportunities due to rapid improvements in healthcare access and a growing pharmaceutical market. Erythromycin can serve as a cost-effective alternative to newer, more expensive antibiotics, making it an attractive option in these regions[5].

Development of Combination Therapies

• Therapeutic Avenues: The development of combination therapies, such as combining erythromycin with prokinetic agents for treating gastrointestinal motility disorders, presents a promising growth opportunity. This can expand erythromycin's market beyond its traditional antibiotic role and attract a broader patient base[5].

Personalized Medicine Approaches

• Tailored Treatments: Personalized medicine approaches, involving genetic testing to determine an individual's likelihood of experiencing side effects or predicting the effectiveness of erythromycin against specific bacterial strains, can enhance its efficacy and safety profile. This trend is expected to drive demand for erythromycin in specific therapeutic contexts[5].

Product Forms and Applications

Forms of Erythromycin Lactobionate

• Injection, Powder, and Lyophilized: Erythromycin lactobionate is available in various forms, including injection, powder, and lyophilized forms, catering to different clinical needs and administration routes[2].

Clinical Applications

• Infections and Gastric Motility: Erythromycin lactobionate is indicated for the treatment of infections caused by susceptible strains of designated organisms, including upper and lower respiratory tract infections, skin infections, and gastrointestinal infections. It is also used to enhance gastric emptying in certain clinical scenarios[1][4].

Safety and Administration

Dosage and Administration

• Recommended Doses: The recommended intravenous dose of erythromycin lactobionate is 15 to 20 mg/kg/day, with higher doses up to 4 g/day for severe infections. It must be administered by continuous or intermittent intravenous infusion due to its irritative properties[3][4].

Adverse Reactions and Interactions

• Potential Side Effects: Erythromycin lactobionate can cause adverse reactions such as severe abdominal pain, nausea, vomiting, diarrhea, hepatitis, pancreatitis, and transient hearing loss, especially at higher doses. It also interacts with various drugs, including those metabolized by the cytochrome P450 system, and can affect the pharmacodynamic effects of other medications[3][4].

Regulatory and Development Trends

Technological Innovations

• Performance Optimization: Technological innovations and advancements are expected to optimize the performance of erythromycin lactobionate, enabling it to acquire a wider range of applications in the downstream market[2].

Regulatory Landscape

• Challenges and Opportunities: The market faces challenges such as antibiotic resistance and stringent regulatory approvals. However, ongoing research and development, along with strategic focus on innovation and quality, will be essential for companies to leverage opportunities in this dynamic market[2][5].

Key Takeaways

• Market Growth: The erythromycin market is projected to grow significantly, driven by the prevalence of bacterial infections and ongoing clinical research.
• Emerging Markets: Expansion in emerging markets offers substantial growth opportunities.
• Combination Therapies: Development of combination therapies can expand erythromycin's therapeutic applications.
• Personalized Medicine: Personalized medicine approaches can enhance the efficacy and safety profile of erythromycin.
• Clinical Applications: Erythromycin lactobionate is versatile, used in treating various infections and enhancing gastric emptying.

FAQs

What is the primary use of erythromycin lactobionate in clinical settings?

Erythromycin lactobionate is primarily used to treat infections caused by susceptible strains of designated organisms when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin.

How does erythromycin lactobionate affect gastric emptying?

Erythromycin lactobionate has been shown to increase gastric emptying in patients undergoing emergency surgery, as demonstrated by the Erythro-Emerge trial.

What are the potential side effects of erythromycin lactobionate?

Potential side effects include severe abdominal pain, nausea, vomiting, diarrhea, hepatitis, pancreatitis, and transient hearing loss, especially at higher doses.

How is erythromycin lactobionate administered?

Erythromycin lactobionate must be administered by continuous or intermittent intravenous infusion due to its irritative properties.

What are the growth opportunities for the erythromycin lactobionate market?

Growth opportunities include expansion in emerging markets, development of combination therapies, and the adoption of personalized medicine approaches.

Sources

1. Erythromycin for Gastric Emptying in Patients Undergoing General Surgery. JAMA Surgery, 2015.
2. Global Erythromycin Lactobionate Market Research Report 2022. Research Reports World.
3. ErythrocinTM Lactobionate - IV. FDA.
4. Erythrocin Lactobionate. RxList.
5. Erythromycin Market Size, Share, Growth | CAGR of 5.6%. Market Research Biz.