CLINICAL TRIALS PROFILE FOR ZINACEF IN PLASTIC CONTAINER

All Clinical Trials for Zinacef In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00730938 ↗	The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery	Completed	Presbyterian Church East Africa Kikuyu Hospital	N/A	2008-02-01	The study investigates whether placing an antibiotic inside the eye at the end of cataract surgery in children will reduce the amount of fibrin formation (fibrin formation can block the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level infection and could be prevented by the antibiotic.
NCT00818610 ↗	Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia	Completed	University Hospital, Geneva	Phase 4	2009-01-01	The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.
NCT00818610 ↗	Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia	Completed	Swiss National Fund for Scientific Research	Phase 4	2009-01-01	The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.
NCT01524081 ↗	Antibiotic Prophylaxis in the Prevention of Surgical Site Infections After Selected Urgent Abdominal Surgical Procedures	Completed	The Faculty Hospital Na Bulovce	Phase 3	2008-07-01	Aim of prospective randomized a placebo controlled study is to prove that in case of acute surgical procedure due to appendicitis, ileus of small bowel and perforation of small bowel and stomach appropriately administered antibiotic prophylaxis is effective with lower incidence of infection in surgical site and comparable risk of development of other nosocomial infections versus group without antibiotic prophylaxis. Secondary aim is to determine risk of developing nosocomial infection in the above mentioned group of patients, identify group of patients which does not benefit from prophylaxis, and compile financial costs for antibiotic prophylaxis and treatment of nosocomial infections and thus the background for the recommended procedure with regards that such prospective study does not exist in the Czech Republic.
NCT02789579 ↗	The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy	Unknown status	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Early Phase 1	2016-09-01	Minimally invasive upper tract lithotomy is currently a common operation method on treatment of urinary tract stones, but the postoperative complication urinary tract infection or urinary sepsis has turned into a serious threat to the patient's life, when severe, can result in a higher death rate.Although more the more importance were attached to, an effective prevention measures still have not been found. Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of postoperative urinary tract infection. The conventional postoperative prophylaxis medicine was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown that continuous preoperative one week use of nitrofurantoin can significantly reduce the incidence of urinary sepsis. So the investigators assume that preoperative extended use time of prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary sepsis. This study uses a computerized random method. According to preoperative use of different antimicrobial drug or treatment, all patients are randomly divided into five groups, namely levofloxacin 3days group,levofloxacin 7days group, nitrofurantoin 3days group,nitrofurantoin 7days group and cefuroxime group.The levofloxacin group receives levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po.to explore the better antibiotics types, medication timing and duration of treatment to prevent postoperative infection after minimally invasive upper tract lithotomy, so as to reduce the incidence of postoperative urinary tract infection or sepsis.
NCT04212078 ↗	Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime	Recruiting	Santen Pharmaceutical Co., Ltd.	Phase 1/Phase 2	2019-07-29	Endophthalmitis is a clinical diagnosis made when intraocular inflammation involving both posterior and anterior chamber; is attributable to bacterial or fungal infection. It is a serious intraocular inflammatory disorder which can be spread via endogenous or exogenous access into the eye by infecting organism. Exogenous spread usually happens post intraocular surgery or procedure (i.e. cataract, vitrectomy, glaucoma filtration surgery) while endogenous spread is associated with hematogenous spread. The occurrence of endophthalmitis accounts for serious post-operative complication which can lead to severe vision loss and even blindness. There are several studies conducted to ascertain the efficiency of intracameral antibiotic as post-operative endophthalmitis prophylaxis. However, there is limited study in human using intracameral levofloxacin to evaluate its effect.This study is designed to compare between intracameral levofloxacin and intracameral cefuroxime in terms of corneal endothelial cell count and its morphology and central corneal thickness in uncomplicated phacoemulsification surgery

Clinical Trial Conditions for Zinacef In Plastic Container

Condition Name

Condition Name for Zinacef In Plastic Container
Intervention	Trials
Acute Appendicitis	1
Cataract	1
Community-acquired Pneumonia	1
Complication of Surgical Procedure	1

Condition MeSH

Condition MeSH for Zinacef In Plastic Container
Intervention	Trials
Endophthalmitis	2
Intestinal Obstruction	1
Appendicitis	1
Urinary Tract Infections	1

Clinical Trial Locations for Zinacef In Plastic Container

Trials by Country

Trials by Country for Zinacef In Plastic Container
Location	Trials
Netherlands	2
Switzerland	2
Czech Republic	1
Malaysia	1
Kenya	1

Clinical Trial Progress for Zinacef In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Zinacef In Plastic Container
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Zinacef In Plastic Container
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for Zinacef In Plastic Container

Sponsor Name

Sponsor Name for Zinacef In Plastic Container
Sponsor	Trials
The Faculty Hospital Na Bulovce	1
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	1
Santen Pharmaceutical Co., Ltd.	1

Sponsor Type

Sponsor Type for Zinacef In Plastic Container
Sponsor	Trials
Other	7
Industry	1

ZINACEF in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

ZINACEF, also known as cefuroxime, is a broad-spectrum cephalosporin antibiotic used to treat a variety of bacterial infections. This article will delve into the clinical trials, market analysis, and future projections for ZINACEF, particularly focusing on its formulation in plastic containers.

Clinical Trials and Efficacy

ZINACEF has been extensively tested in clinical trials to establish its efficacy and safety profile. These trials have shown that ZINACEF is effective against a wide range of bacterial infections, including lower respiratory tract infections, skin and skin-structure infections, urinary tract infections, and gonococcal infections[1][4].

Spectrum of Activity

ZINACEF is active against various gram-positive and gram-negative bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, Neisseria gonorrhoeae, and Staphylococcus aureus (including penicillinase-producing strains)[1][4].

Dosage and Administration

In clinical trials, the usual adult dosage range for ZINACEF is 750 mg to 1.5 grams every 8 hours, with adjustments based on the severity of the infection and the patient's condition. For life-threatening infections or those caused by less susceptible organisms, higher doses may be required[4].

Market Analysis

Global Market Overview

The market for ZINACEF, as part of the broader cephalosporin market, is analyzed based on global, regional, and country-level insights. The global cefuroxime API market is expected to grow significantly from 2024 to 2031, driven by increasing demand for effective antibiotics and rising investments in pharmaceutical research and development[5].

Regional Analysis

The market is segmented into major regions such as North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Asia-Pacific is expected to be a key growth region due to its large population and increasing healthcare expenditure[5].

Market Drivers and Restraints

Key drivers of the ZINACEF market include the rising incidence of bacterial infections, advancements in pharmaceutical technology, and increased R&D activities. However, high costs and stringent government regulations on plastic usage could hamper market growth[2][5].

Market Projections

Forecast Period

The forecast period for the ZINACEF market extends from 2025 to 2031, with the base year being 2023. During this period, the market is expected to grow at a significant CAGR, driven by the increasing demand for antibiotics and the expanding global healthcare infrastructure[2][5].

Segment Analysis

The market is segmented by type (purity levels such as ≥ 98% and ≥ 99%) and application (injection, tablets, capsules). The injection segment is expected to dominate the market due to the parenteral administration of ZINACEF being a common practice[5].

Clinical Trial Packaging and Plastic Containers

Clinical Trial Packaging Trends

The clinical trial packaging market, which includes the packaging of drugs like ZINACEF, is expected to grow due to the increased number of clinical trials post-COVID-19. There is a rising demand for innovative and sustainable packaging solutions, which includes the use of plastic containers that are safe and compliant with regulatory standards[3].

Challenges and Opportunities

While plastic containers offer convenience and sterility, they are also subject to stringent regulations due to environmental concerns. Manufacturers are focusing on sustainable packaging materials and smart packaging solutions to address these challenges and capitalize on emerging trends[3].

Key Considerations for ZINACEF in Plastic Containers

Stability and Compatibility

ZINACEF solutions in plastic containers must be stable and compatible with the container material. For instance, TwistVial™ vials that have been joined to compatible diluent containers are stable for 24 hours at room temperature or for 7 days under refrigeration[4].

Regulatory Compliance

Ensuring compliance with regulatory standards is crucial. This includes adhering to guidelines on the use of plastic materials, labeling, and storage conditions to maintain the efficacy and safety of the drug[4].

Conclusion

ZINACEF, formulated in plastic containers, remains a vital antibiotic in the treatment of various bacterial infections. The drug's efficacy has been well-established through clinical trials, and its market is projected to grow significantly over the next few years. However, manufacturers must navigate the challenges of regulatory compliance and environmental sustainability in the use of plastic containers.

Key Takeaways

• Efficacy and Spectrum: ZINACEF is effective against a broad range of bacterial infections.
• Market Growth: The global cefuroxime API market is expected to grow significantly from 2025 to 2031.
• Regional Analysis: Asia-Pacific is a key growth region.
• Packaging Trends: There is a growing demand for sustainable and innovative packaging solutions.
• Regulatory Compliance: Ensuring compliance with regulatory standards is essential.

FAQs

What is the typical dosage range for ZINACEF?

The usual adult dosage range for ZINACEF is 750 mg to 1.5 grams every 8 hours, with adjustments based on the severity of the infection and the patient's condition[4].

Which regions are expected to dominate the ZINACEF market?

Asia-Pacific is expected to be a key growth region due to its large population and increasing healthcare expenditure[5].

What are the key drivers of the ZINACEF market?

Key drivers include the rising incidence of bacterial infections, advancements in pharmaceutical technology, and increased R&D activities[2][5].

What are the challenges associated with using plastic containers for ZINACEF?

Challenges include high costs and stringent government regulations on plastic usage, as well as the need for sustainable packaging solutions[2][3].

How stable are ZINACEF solutions in plastic containers?

ZINACEF solutions in TwistVial™ vials are stable for 24 hours at room temperature or for 7 days under refrigeration[4].

Sources

1. ZINACEF® (cefuroxime for injection) Label - FDA.
2. Zinacef Market Report 2024 (Global Edition) - Cognitive Market Research.
3. Clinical Trial Packaging Market Size & Detailed Analysis [2032] - Fortune Business Insights.
4. ZINACEF (cefuroxime for injection) Label - FDA.
5. Global Cefuroxime API Market Report 2024 Edition - Cognitive Market Research.

Last updated: 2025-01-03