CLINICAL TRIALS PROFILE FOR GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

All Clinical Trials for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03392909 ↗	Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)	Recruiting	University of Southern California	Phase 1/Phase 2	2018-07-05	Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators recently demonstrated in 5 such patients that intradermal and topical gentamicin induced "read-through" of their nonsense mutations and created robust and sustained new C7 and AFs at the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and reduced new blister formation. No untoward side effects occurred. Herein, the investigators propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In theory, this intravenous administration has the possibility of treating simultaneously all of the patients' skin wounds. The milestones will be increased C7 and AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of gentamicin side effects.
NCT03012191 ↗	Gentamicin for RDEB	Completed	University of Southern California	Phase 1/Phase 2	2017-02-02	Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators recently demonstrated in 5 such patients that intradermal and topical gentamicin induced "read-through" of their nonsense mutations and created robust and sustained new C7 and AFs at the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and reduced new blister formation. No untoward side effects occurred. Herein, the investigators propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In theory, this intravenous administration has the possibility of treating simultaneously all of the patients' skin wounds. The investigators also propose optimizing the concentration and manner of delivery of topical gentamicin. The unambiguous milestones will be increased C7 and AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of significant gentamicin side effects.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT02036528 ↗	Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers	Terminated	Royer Biomedical, Inc.	Phase 1/Phase 2	2014-01-01	The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to moderately infected foot ulcers in diabetic patients.
NCT00671528 ↗	Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)	Terminated	Merck Sharp & Dohme Corp.	Phase 4	2009-07-01	This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema: - Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) - Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream - Arm C: Betamethasone diproprionate cream At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile. Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed. Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.
NCT01878643 ↗	Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit	Completed	Stony Brook University	Early Phase 1	2001-12-01	The purpose of this study was : - to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients - to determine the effect of inhaled antibiotics on respiratory infection

Clinical Trial Conditions for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Spinal Cord Injuries	2
Neurogenic Bladder	2
Recessive Dystrophic Epidermolysis Bullosa	2
Diabetic Foot Ulcers	1

Condition MeSH

Condition MeSH for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Epidermolysis Bullosa	4
Infections	3
Infection	3
Urinary Tract Infections	3

Clinical Trial Locations for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

+

−

Trials by Country for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	13
Norway	1
Kenya	1
China	1

Trials by US State

+

−

Trials by US State for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
California	4
Michigan	2
Georgia	1
Florida	1
District of Columbia	1

Clinical Trial Progress for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Recruiting	5
Completed	2
Unknown status	2

Clinical Trial Sponsors for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
University of Southern California	3
Kenya Ministry of Health	1
Merck Sharp & Dohme Corp.	1

Sponsor Type

Sponsor Type for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	20
Industry	2

Gentamicin Sulfate in Sodium Chloride 0.9%: Clinical Trials, Market Analysis, and Projections

Introduction

Gentamicin sulfate, an aminoglycoside antibiotic, is widely used in various medical applications, including treating bacterial infections and certain genetic disorders. This article will delve into the current clinical trials, market analysis, and future projections for gentamicin sulfate, particularly when administered in a 0.9% sodium chloride solution.

Clinical Trials Update

Gentamicin in Junctional Epidermolysis Bullosa (JEB)

A recent clinical trial published in JAMA Dermatology evaluated the safety and efficacy of intravenous gentamicin therapy in patients with Junctional Epidermolysis Bullosa (JEB), a rare genetic skin disorder. The trial involved five pediatric patients who received either low or high doses of gentamicin for a specified period. The results showed that gentamicin induced readthrough of nonsense variants, restored functional laminin 332 in the skin, and facilitated wound closure during the study period. Although long-term safety and efficacy need further evaluation, this study suggests that gentamicin could be a safe and effective short-term therapy for JEB patients[1].

Gentamicin in Urinary Tract Infections (UTIs)

Another clinical trial focused on the use of intravesical gentamicin instillations to reduce urinary tract infections in patients with neurogenic bladder after spinal cord injury (SCI). This study aims to assess the efficacy of gentamicin in decreasing UTI frequency and improving quality of life for these patients. The trial design involves a pre-post comparison of UTI incidence before and during the six-month treatment period. The selection of gentamicin is based on its antimicrobial efficacy and safety profile in this patient population[4].

Stability and Formulation

Gentamicin sulfate has been evaluated for its physical and chemical stability in various formulations. Studies have shown that gentamicin sulfate remains stable when admixed in 0.9% sodium chloride injection and stored under appropriate conditions. For instance, it has been demonstrated to be stable for 24 hours at 25°C and up to 30 days at 4°C when packaged in Autodose Infusion System Bags. This stability is crucial for its use in clinical settings[3].

Market Analysis

Global Market Size and Growth

The global market for gentamicin sulfate is projected to grow significantly over the next few years. As of 2022, the market size was valued at USD 580 million and is expected to reach USD 930 million by 2030, growing at a CAGR of 6.3% from 2024 to 2030. This growth is driven by the increasing demand for effective antibiotics, particularly in healthcare settings, due to rising hospital-acquired infections (HAIs) and antibiotic-resistant bacterial strains[5].

Market Segments and Drivers

The gentamicin sulfate market is segmented by product type, application, and region. Key drivers include the expanding healthcare infrastructure, increasing awareness about infection treatment in developing economies, and advancements in pharmaceutical manufacturing processes. The market also benefits from growing veterinary applications and collaborations between pharmaceutical companies and research institutions to improve gentamicin formulations and delivery systems[5].

Regional Analysis

The market is analyzed across major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region's revenue share, current trends, and future prospects are evaluated to provide a comprehensive market overview. The report includes detailed insights into the segments that are expected to be most lucrative in the near future and their anticipated growth rates[2].

Market Projections

Future Scope and Trends

The future of the gentamicin sulfate market appears promising, driven by rising consumer demand, developing technologies, and growing applications. The market is expected to benefit from increasing disposable incomes, urbanization, and sustainability trends. Legislative support and growing awareness about infection treatment are also expected to drive market growth in emerging economies[5].

Opportunities and Challenges

Potential opportunities in the gentamicin sulfate market include the development of novel drug formulations and expanding market presence in emerging economies. However, challenges such as the risk of antibiotic resistance and the need for continuous innovation to stay ahead of bacterial mutations must be addressed. Collaborations between pharmaceutical companies and research institutions are crucial for overcoming these challenges[5].

Key Players

Major players in the gentamicin sulfate market include Pfizer Inc., Merck & Co. Inc., and Sandoz International GmbH. These companies are investing in research and development to improve gentamicin formulations and expand their market presence globally[5].

Conclusion

Gentamicin sulfate, administered in a 0.9% sodium chloride solution, is a versatile antibiotic with significant clinical and market potential. Clinical trials have shown promising results in treating rare genetic disorders and reducing urinary tract infections. The market for gentamicin sulfate is expected to grow substantially, driven by increasing demand for effective antibiotics and advancements in pharmaceutical manufacturing.

Key Takeaways

• Clinical Efficacy: Gentamicin sulfate has shown efficacy in treating JEB and reducing UTIs in patients with neurogenic bladder.
• Market Growth: The global market is projected to grow at a CAGR of 6.3% from 2024 to 2030.
• Stability: Gentamicin sulfate is stable in 0.9% sodium chloride solutions under appropriate storage conditions.
• Market Drivers: Expanding healthcare infrastructure, increasing awareness, and advancements in manufacturing processes drive market growth.
• Future Prospects: The market is expected to benefit from rising consumer demand, developing technologies, and growing applications.

FAQs

Q: What is the primary use of gentamicin sulfate in clinical trials?

A: Gentamicin sulfate is being used in clinical trials to treat Junctional Epidermolysis Bullosa (JEB) and to reduce urinary tract infections (UTIs) in patients with neurogenic bladder.

Q: How stable is gentamicin sulfate in 0.9% sodium chloride solution?

A: Gentamicin sulfate has been shown to be stable for 24 hours at 25°C and up to 30 days at 4°C when packaged in appropriate containers.

Q: What are the key drivers of the gentamicin sulfate market?

A: Key drivers include the expanding healthcare infrastructure, increasing awareness about infection treatment, and advancements in pharmaceutical manufacturing processes.

Q: Which regions are expected to be most lucrative for the gentamicin sulfate market?

A: The market is expected to be lucrative in regions such as North America, Europe, and the Asia Pacific, driven by growing demand and expanding healthcare infrastructure.

Q: What are the potential opportunities in the gentamicin sulfate market?

A: Opportunities include the development of novel drug formulations and expanding market presence in emerging economies.

Sources

1. JAMA Dermatology: "Gentamicin Outcomes for Patients With Junctional Epidermolysis Bullosa"
2. Cognitive Market Research: "Global Gentamicin Sulfate Ophthalmic Ointment Market Report 2025"
3. Purdue e-Pubs: "Product Information Report: Gentamicin"
4. ClinicalTrials.gov: "The Effect of Gentamicin Intravesical Instillations on Decreasing Urinary Tract Infections in Patients with Neurogenic Bladder after SCI"
5. Growth-Leaderships: "Gentamycin Sulfate (CAS 1405-41-0) Market Key Drivers and Forecast 2025-2032"