CLINICAL TRIALS PROFILE FOR CEFTRIAXONE SODIUM; LIDOCAINE

All Clinical Trials for ceftriaxone sodium; lidocaine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03853096 ↗	P.Acnes Colony Count Following Subdermal Cefazolin	Unknown status	University of British Columbia	Early Phase 1	2019-04-01	The specific outcome is to determine whether the colony count of Propionibacterium acnes, one of the commonest causes of shoulder infection and not eradicated by conventional forms of surgical preparatory solutions and antibiotics, in a shoulder surgical wound will be altered by the use of subdermal cefazolin.
NCT03587441 ↗	Intrathecal Neostigmine for Prevention of PDPH	Completed	Fayoum University Hospital	Phase 4	2018-08-04	Neuraxial blocks continue to be the cornerstone of anesthesia and postoperative analgesia for normal vaginal delivery and elective caesarean section due to its approved safety and efficiency for decades. Post-dural puncture headache (PDPH) is still one of the most common complications of neuraxial anesthetic techniques. The headache could be severe and limit the activities of the new mother to care for her baby, prolong hospital stay. PDPH is defined as a headache that develops within five days of dural puncture and can't be attributed to any other types of headache and mostly is postural in character. Neostigmine methylsulfate is a synthetic carbamic acid ester which reversibly inhibits the enzyme Acetylcholine esterase (AChE) that makes more Acetylcholine molecules available at cholinergic receptors. Neostigmine is used in anesthesia mainly as a reversal for non-depolarizing neuromuscular agents. Intrathecal (IT) neostigmine was tried as an adjuvant to local anesthetics in IT block for elective cesarean sections to decrease local anesthetic consumption and to prolong postoperative analgesia. Side effects of IT neostigmine are dose-dependent with doses more than 25 µg especially nausea and vomiting and could be decreased by increasing the baricities of the local anesthetic solutions and by early head up position after IT injection. However, its effect on PDPH was not investigated before in literature. Parturients will be randomly assigned into one of two groups: the intervention group will receive 20 µg with IT Bupivacaine and the control group will receive an equivalent volume of dextrose 5% with the IT Bupivacaine. The objective of the current study is to evaluate the efficacy and safety of IT neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section.

Clinical Trial Conditions for ceftriaxone sodium; lidocaine

Condition Name

Condition Name for ceftriaxone sodium; lidocaine
Intervention	Trials
Post-Dural Puncture Headache	1
Surgical Site Infection	1
Microbial Colonization	1

Condition MeSH

Condition MeSH for ceftriaxone sodium; lidocaine
Intervention	Trials
Surgical Wound Infection	1
Infections	1
Infection	1

Clinical Trial Locations for ceftriaxone sodium; lidocaine

Trials by Country

+

−

Trials by Country for ceftriaxone sodium; lidocaine
Location	Trials
Egypt	1

Clinical Trial Progress for ceftriaxone sodium; lidocaine

Clinical Trial Phase

Clinical Trial Phase for ceftriaxone sodium; lidocaine
Clinical Trial Phase	Trials
Phase 4	1
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for ceftriaxone sodium; lidocaine
Clinical Trial Phase	Trials
Unknown status	1
Completed	1

Clinical Trial Sponsors for ceftriaxone sodium; lidocaine

Sponsor Name

Sponsor Name for ceftriaxone sodium; lidocaine
Sponsor	Trials
University of British Columbia	1
Fayoum University Hospital	1

Sponsor Type

Sponsor Type for ceftriaxone sodium; lidocaine
Sponsor	Trials
Other	2

Ceftriaxone Sodium and Lidocaine: Clinical Trials, Market Analysis, and Projections

Introduction

Ceftriaxone sodium, a third-generation cephalosporin antibiotic, is widely used for treating various bacterial infections. When combined with lidocaine, it offers an additional benefit of reduced pain during intramuscular injections. This article delves into the clinical trials, market analysis, and future projections for ceftriaxone sodium, particularly when used with lidocaine.

Clinical Trials: Pain Reduction with Lidocaine

Several clinical trials have focused on the pain associated with intramuscular injections of ceftriaxone sodium when using different diluents. A key study compared the pain experienced by adolescents receiving ceftriaxone injections diluted with either lidocaine hydrochloride or sterile water[1][4].

Methodology

The prospective study involved 39 adolescents and young adults with gonorrhea. The diluent used for the intramuscular ceftriaxone therapy was randomly selected. Pain predictions were elicited before treatment, and pain ratings were obtained at multiple intervals post-injection using a visual analog scale.

Results

The study found significant pain differences between the two groups. Lidocaine hydrochloride as a diluent reduced the pain associated with ceftriaxone injections compared to sterile water. This reduction in pain was evident immediately after the injection and at subsequent time intervals up to 6 hours[1][4].

Market Analysis

The global ceftriaxone market is experiencing significant growth driven by several key factors.

Efficacy in Treating Multi-Drug Resistant Infections

Ceftriaxone's effectiveness against a broad spectrum of bacteria, including those resistant to other antibiotics, is a major driver of its market growth. This efficacy is supported by numerous clinical studies and real-world patient outcomes[3].

Growing Incidence of Bacterial Infections

The increasing prevalence of bacterial infections such as urinary tract infections, pneumonia, and other indications that ceftriaxone effectively addresses, is another key driver. Major pharmaceutical companies like Pfizer have played a crucial role in raising awareness about these infections and the importance of timely treatment[3].

Expansion of Indications and Therapeutic Applications

Ceftriaxone is being explored for new therapeutic applications beyond its conventional uses. Clinical trials and real-world evidence highlight its potential in treating intra-abdominal infections, acute bacterial otitis media, and other conditions, contributing to its market growth[3].

Market Segmentation and Distribution

Indication Segmentation

The ceftriaxone market is segmented by various indications, with pneumonia being the highest revenue-generating segment in 2023. However, acute bacterial otitis media is expected to exhibit the highest compound annual growth rate (CAGR) during the forecast period from 2024 to 2032[3].

Distribution Channels

Hospital pharmacies currently dominate the distribution channel, but online pharmacies are expected to exhibit the highest CAGR during the forecast period, driven by increasing digital healthcare trends[3].

Geographical Trends

Asia-Pacific and North America

The Asia-Pacific region is expected to witness the highest CAGR from 2024 to 2032, driven by the increasing burden of bacterial infections and improving healthcare infrastructure. North America, with its robust healthcare systems and high prevalence of bacterial infections, is anticipated to maintain its position as the highest revenue-generating region[3].

Challenges and Concerns

Antibiotic Stewardship and Resistance

Despite its efficacy, the ceftriaxone market faces challenges related to antibiotic stewardship and resistance concerns. The overuse and misuse of antibiotics have led to the development of resistant bacterial strains, necessitating effective stewardship programs to mitigate these issues[3].

Stability and Shelf-Life

Ceftriaxone preparations, including those with lidocaine hydrochloride, have undergone extensive stability studies. These studies have shown that ceftriaxone powder and lidocaine hydrochloride solutions remain stable under various conditions, supporting a shelf-life of up to 24 months for the combined product[2].

Pharmaceutical Development

The development of ceftriaxone products, such as Ceftriaxon Sandoz, involves the use of lidocaine hydrochloride as a diluent to enhance patient comfort. These products are designed to be equivalent to brand leader products and have been approved based on comprehensive evaluation processes[2].

Key Takeaways

• Pain Reduction: Lidocaine hydrochloride significantly reduces the pain associated with intramuscular ceftriaxone injections.
• Market Growth: The ceftriaxone market is expected to grow at a CAGR of 3.1% from 2024 to 2032, driven by its efficacy in treating multi-drug resistant infections and the growing incidence of bacterial infections.
• Geographical Trends: Asia-Pacific and North America are key regions, with the former expected to witness the highest CAGR and the latter maintaining its position as the highest revenue-generating region.
• Challenges: Antibiotic stewardship and resistance concerns remain significant challenges that need to be addressed.

FAQs

What is the primary benefit of using lidocaine hydrochloride as a diluent for ceftriaxone injections?

The primary benefit is the significant reduction in pain associated with intramuscular injections of ceftriaxone[1][4].

What are the key drivers of the ceftriaxone market growth?

The key drivers include its efficacy in treating multi-drug resistant infections, the growing incidence of bacterial infections, and the expansion of indications and therapeutic applications[3].

Which region is expected to witness the highest CAGR in the ceftriaxone market from 2024 to 2032?

The Asia-Pacific region is expected to witness the highest CAGR during this period, driven by the increasing burden of bacterial infections and improving healthcare infrastructure[3].

What are the main challenges facing the ceftriaxone market?

The main challenges include antibiotic stewardship and resistance concerns, which require ongoing attention and effective management strategies[3].

What is the shelf-life of ceftriaxone products when combined with lidocaine hydrochloride?

The combined product has a shelf-life of up to 24 months, supported by extensive stability studies[2].

Sources

1. Lidocaine as a diluent for ceftriaxone in the treatment of gonorrhea - PubMed
2. Public Assessment Report - Cbg-meb - Medicines Evaluation Board in the Netherlands
3. Ceftriaxone Industry Research 2024 - GlobeNewswire
4. Lidocaine as a Diluent for Ceftriaxone in the Treatment of Gonorrhea - JAMA Network
5. Enhanced HPLC-MSMS Method for the Quantitative Determination of the Co-administered Drugs Ceftriaxone Sodium and Lidocaine Hydrochloride in Human Plasma - ResearchGate