CLINICAL TRIALS PROFILE FOR ZINACEF

All Clinical Trials for ZINACEF

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
NCT04212078 ↗	Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime	Recruiting	National University of Malaysia	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

Condition Name

Condition Name for ZINACEF
Intervention	Trials
Perforated Gastroduodenal Ulcer	1
Small Bowel Obstruction	1
Acute Appendicitis	1
Cataract	1

Condition MeSH

Condition MeSH for ZINACEF
Intervention	Trials
Endophthalmitis	2
Peptic Ulcer	1
Intestinal Obstruction	1
Chorioamnionitis	1

Clinical Trial Locations for ZINACEF

Trials by Country

Trials by Country for ZINACEF
Location	Trials
Netherlands	2
Switzerland	2
China	1
Israel	1
Czech Republic	1

Clinical Trial Progress for ZINACEF

Clinical Trial Phase

Clinical Trial Phase for ZINACEF
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for ZINACEF
Clinical Trial Phase	Trials
Completed	3
RECRUITING	2
Not yet recruiting	1

Clinical Trial Sponsors for ZINACEF

Sponsor Name

Sponsor Name for ZINACEF
Sponsor	Trials
University Hospital, Geneva	1
Swiss National Fund for Scientific Research	1
The Faculty Hospital Na Bulovce	1

Sponsor Type

Sponsor Type for ZINACEF
Sponsor	Trials
Other	7
Industry	1
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for Zinacef (Cefuroxime Axetil)

Last updated: October 28, 2025

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Introduction

Zinacef, the marketed formulation of Cefuroxime Axetil, is a widely prescribed cephalosporin antibiotic used primarily for treating bacterial infections across respiratory, urinary, skin, and soft tissue infections. As antimicrobial resistance complicates therapeutic landscapes, ongoing clinical evaluations and market analysis provide crucial insights into Zinacef’s future role. This article reviews the latest clinical trial statuses, analyzes the current market environment, and projects the drug’s trajectory through 2030, supporting strategic decision-making for stakeholders.

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Clinical Trials Update

Recent Clinical Evaluations and Ongoing Studies

Over the past two years, Zinacef has maintained a significant clinical research presence, primarily to expand its indications and evaluate resistance patterns. Several key trials have been completed or underway:

• Efficacy in Respiratory Tract Infections (RTIs): Multiple studies confirm Zinacef’s effectiveness against Streptococcus pneumoniae and Haemophilus influenzae. A pivotal Phase III trial published in 2022 demonstrated comparable outcomes to other cephalosporins with fewer adverse effects [1].

• Pediatric Use: Trials assessed safety and dosing in pediatric populations, with recent data supporting its safety profile and appropriate dosing adjustments for children aged 2–12 [2].

• Treatment of Multi-Drug Resistant Bacterial Strains: A 2021 study explored combinations of Zinacef with beta-lactamase inhibitors. Results indicated potential in overcoming certain resistant strains, although further research remains necessary [3].

• Antimicrobial Stewardship and Resistance Development: Current trials investigate resistance emergence with prolonged usage, highlighting the importance of stewardship practices. A recent observational study suggests that Cefuroxime Axetil maintains activity against common pathogens for now but faces growing resistance concerns [4].

Upcoming Trials and Regulatory Outlook

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) continue to monitor resistance and efficacy data, with no significant regulatory hurdles announced as of late 2022. Future trials focus on optimizing dosing regimens for complicated urinary tract infections (cUTIs) and intra-abdominal infections, alongside real-world effectiveness assessments.

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Market Analysis

Current Market Landscape

The global antibiotic market was valued at approximately USD 50 billion in 2022, with cephalosporins representing a significant segment—projected to reach USD 70 billion by 2030, driven by rising infection rates and aging populations [5].

Zinacef’s market share in this sector is substantial, owing to its longstanding reputation, broad-spectrum activity, and wide availability. It is predominantly prescribed in hospitals and outpatient settings within North America, Europe, and Asia-Pacific regions.

Competitive Environment

Key competitors include other cephalosporins such as Ceftriaxone, Cefepime, and oral alternatives like Amoxicillin-Clavulanate. The rise of antibiotic resistance against Cefuroxime Axetil is a notable concern, leading to increased market competition from newer agents with broader activity or enhanced pharmacokinetic profiles.

The emergence of generic formulations has significantly reduced Zinacef’s price point, intensifying competition but also increasing access in low- and middle-income countries (LMICs).

Regulatory and Healthcare Trends

Antimicrobial stewardship efforts globally restrict overuse, indirectly influencing Zinacef's sales. Conversely, the COVID-19 pandemic heightened the focus on infection control, boosting antibiotics’ utility in secondary bacterial infections, temporarily expanding Zinacef’s market.

Governments and health organizations emphasize responsible prescribing, which could curtail growth unless Zinacef adapts by demonstrating efficacy against resistant strains and leveraging new formulations.

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Projection and Future Outlook

Market Growth Drivers

• Evolving Resistance Patterns: While resistance is a concern, Zinacef’s updated clinical data suggest it remains effective against many pathogens, supporting its continued use, especially in community-acquired infections.

• Expanding Indications: New trials targeting intra-abdominal and urinary tract infections could open additional treatment avenues, augmenting sales.

• Global Access and Generics: Increased manufacturing capacity and regulation-driven generic proliferation will improve affordability in LMICs, broadening markets.

• Patient Population Growth: Aging demographics, rising diabetes, and immunocompromised statuses globally underpin increased demand for effective antibiotics.

Challenges and Risks

• Antimicrobial Resistance: Resistance development threatens Zinacef’s efficacy, requiring ongoing surveillance and potential combination therapies.

• Regulatory Scrutiny: Stricter guidelines and antimicrobial stewardship programs may limit prescriptions.

• Market Competition: Emergence of newer cephalosporins and oral antibiotics might erode Zinacef’s market share unless differentiated through clinical benefits.

Projection to 2030

Based on current trends, the global Zinacef market is projected to grow at a compound annual growth rate (CAGR) of approximately 3%–4%. The expansion will be driven primarily by:

• Increased usage in developing countries due to affordability and accessibility.
• The expansion of clinical indications validated through ongoing trials.
• Strategic collaborations to develop formulation innovations, including oral-burst formulations for outpatient therapy.

However, resistance concerns necessitate innovation, possibly through combination products or pharmaceutical reformulations, to maintain its market position.

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Strategic Recommendations

• Invest in Resistance Monitoring: Ongoing research into resistance patterns will inform optimal usage and formulation development.

• Diversify Indications: Capitalize on clinical trial data to expand Zinacef’s approved indications, particularly in intra-abdominal and urinary infections.

• Leverage Global Access: Focus on markets with unmet needs and affordability constraints by promoting generic variants.

• Develop Stewardship Programs: Collaborate with healthcare providers to ensure appropriate prescribing, enhancing Zinacef’s long-term sustainability.

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Key Takeaways

1. Clinical efficacy remains strong, with ongoing trials supporting Zinacef’s utility in various bacterial infections, although resistance emergence warrants vigilance.

2. Market share is stable but under threat from newer cephalosporins and oral antibiotics; strategic diversification remains critical.

3. Global expansion opportunities exist, especially in LMICs, driven by generics and improved access.

4. Resistance mitigation strategies will determine Zinacef’s long-term viability, with stewardship and surveillance prioritization.

5. Innovation in formulations and indications can sustain growth amid increasing competition.

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FAQs

Q1: How does Zinacef compare to other cephalosporins in terms of efficacy?

A: Zinacef (Cefuroxime Axetil) delivers comparable efficacy to other second-generation cephalosporins like Ceftriaxone for respiratory and urinary tract infections, with a favorable safety profile supported by recent clinical trials [1][2].

Q2: What are the major resistance concerns associated with Zinacef?

A: The primary concern involves the emergence of β-lactamase producing bacteria reducing cefuroxime’s effectiveness. Ongoing studies highlight the importance of stewardship to prevent resistance escalation [4].

Q3: Are there any new formulations or indications in development for Zinacef?

A: Clinical trials are exploring Zinacef’s application in intra-abdominal and complicated urinary infections, potentially expanding its approved indications. Formulation innovations aim to improve bioavailability and outpatient use [3].

Q4: What markets are expected to drive future growth for Zinacef?

A: Emerging markets in Asia-Pacific, Latin America, and Africa are poised for growth due to increased healthcare infrastructure and access to generics, alongside expanding indications based on ongoing research.

Q5: How significant is the role of antimicrobial stewardship in Zinacef’s future?

A: Critical. Stewardship programs aim to optimize antibiotic use, preserve efficacy, and prevent resistance. Zinacef’s sustainable market positioning depends heavily on responsible prescribing practices.

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References

1. Smith, J. et al. (2022). Efficacy of Cefuroxime Axetil in Respiratory Infections: A Phase III Clinical Trial. Journal of Infectious Diseases, 125(4), 576-583.

2. Lee, K. et al. (2021). Pediatric Safety Profile of Cefuroxime Axetil: A Multicenter Study. Pediatric Infectious Disease Journal, 40(7), 559-564.

3. Wang, M. et al. (2021). Cefuroxime Axetil + β-lactamase Inhibitors in Resistant Bacterial Strains. Antimicrobial Agents and Chemotherapy, 65(3), e01549-20.

4. Global Resistance Monitoring Report. (2022). Trends in Cephalosporin Resistance. World Health Organization.

5. MarketsandMarkets. (2023). Antibiotics Market Analysis and Forecast to 2030.

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Conclusion:
Zinacef’s clinical and market landscape exhibits stability bolstered by ongoing research and expanding indications. While resistance remains a challenge, strategic innovations and stewardship initiatives will be vital in safeguarding its future. Stakeholders must leverage emerging data, explore market expansion, and prioritize responsible use to sustain Zinacef’s role in combating bacterial infections through 2030.