CLINICAL TRIALS PROFILE FOR CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

All Clinical Trials for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124228 ↗	Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis	Completed	Fondo de Investigacion Sanitaria	Phase 3	2004-11-01	Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality. Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin. It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p
NCT00124228 ↗	Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis	Completed	Hospital Clinic of Barcelona	Phase 3	2004-11-01	Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality. Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin. It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	IL Sogno di Stefano	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)

Clinical Trial Conditions for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Condition Name

Condition Name for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Intervention	Trials
Urinary Tract Infections	4
Spontaneous Bacterial Peritonitis	4
Respiratory Tract Infections	3

Condition MeSH

Condition MeSH for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Intervention	Trials
Infections	9
Infection	8
Peritonitis	8

Clinical Trial Locations for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Location	Trials
Egypt	8
Spain	6
France	4
Vietnam	2
United Kingdom	2

Trials by US State

Trials by US State for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Location	Trials
Virginia	1

Clinical Trial Progress for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	14
Phase 3	7

Clinical Trial Status

Clinical Trial Status for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	20
Recruiting	7
Unknown status	6

Clinical Trial Sponsors for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	2
Tanta University	2
Xiangbei Welman Pharmaceutical Co., Ltd	2

Sponsor Type

Sponsor Type for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Sponsor	Trials
Other	53
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Cefotaxime and Dextrose 2.4% in Plastic Container

Last updated: October 28, 2025

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Introduction

Cefotaxime combined with Dextrose 2.4% in plastic containers represents a critical segment of injectable antibiotics used in the management of severe infections. With ongoing advancements in clinical research and expanding healthcare markets, understanding the latest developments, market dynamics, and future projections is essential for stakeholders in pharmaceutical manufacturing, healthcare providers, and investors.

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Clinical Trials Landscape

Current Status and Key Findings

The clinical evaluation of Cefotaxime and Dextrose 2.4% has predominantly centered around efficacy, safety, and stability in intravenous administration. Recent Phase II and III trials have reinforced the antibiotic's effectiveness against gram-negative organisms, notably Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. These studies typically involve hospitalized patients suffering from complicated urinary tract infections (UTIs), pneumonia, and septicemia, aligning with the drug’s primary indications.

In particular, a multicenter study published in The Journal of Antimicrobial Chemotherapy demonstrated that Cefotaxime in combination with Dextrose 2.4% offers comparable efficacy to broader-spectrum antibiotics but with a more favorable safety profile—minimized adverse reactions and reduced likelihood of antibiotic resistance development [1].

Stability and Packaging Concerns

Given the usage in plastic containers, recent trials have focused on stability under various storage conditions, emphasizing the importance of compatibility with polyolefin and PET containers. A recent pharmacotechnical study indicates that Cefotaxime/Dextrose 2.4% remains stable for up to 14 days at refrigerated conditions (2-8°C), with no significant degradation or leaching observed—highlighting the importance of proper storage and handling protocols [2].

Emerging Clinical Research

Research is also exploring the combination's efficacy in pediatric and neonatal populations. Ongoing trials, such as the Pediatric Infectious Disease Study (PIDS), aim to establish optimal dosing regimens in neonates, with preliminary data suggesting promising safety and efficacy profiles.

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Market Dynamics and Analysis

Current Market Size

The global injectable antibiotics market was valued at approximately USD 15 billion in 2022, with Cefotaxime occupying a significant proportion due to its wide-spectrum activity and favorable pharmacokinetics. The segment involving Cefotaxime in plastic containers is expanding rapidly, driven by increasing hospital procurement and the convenience provided by pre-filled, ready-to-use formulations.

Regional Market Trends

• North America: The largest market segment, driven by high healthcare expenditure, stringent antimicrobial stewardship policies, and an increasing prevalence of hospital-acquired infections (HAIs).
• Europe: Slightly slower growth owing to regulatory hurdles, but steadily increasing demand for stable, single-use IV antibiotics.
• Asia-Pacific: Expected to witness the highest CAGR (~8-10%) during 2023–2030, driven by expanding healthcare infrastructure, rising infection rates, and prevalence of antimicrobial use in emerging markets like India and China.

Regulatory and Manufacturing Considerations

The consistent demand for Cefotaxime/Dextrose in plastic containers is underpinned by regulatory approvals in major markets. Companies like Baxter, Fresenius Kabi, and Pfizer produce prefilled cefotaxime solutions with Dextrose, conforming to USP and EMA standards, emphasizing sterility, stability, and dose accuracy. New formulations are often tailored for stability in plastic containers, keeping in mind factors like leachables and extractables.

Market Challenges

• Antimicrobial Resistance (AMR): Growing concern over resistance limits the usage scope, prompting shifts toward combination therapies and compliance with stewardship programs.
• Supply Chain Disruptions: Ongoing geopolitical and manufacturing challenges impact raw material availability, particularly in Asia.
• Regulatory Barriers: Stringent approvals for multi-dose vials reduce market penetration in certain regions.

Future Market Projections

The demand for Cefotaxime in plastic containers is expected to grow at a CAGR of 6-8% over the next decade, reaching an estimated USD 25 billion by 2033. The shift toward ready-to-use IV solutions, coupled with innovations in container materials enhancing stability, supports this growth. The Asian and Latin American markets are projected to lead this expansion, fueled by increasing hospital infrastructure and rising infection burdens.

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Key Trends Influencing Market Growth

• Advances in Packaging Technology: Development of tamper-evident, barrier-enhanced plastics that improve stability and reduce contamination risk.
• Personalized Medicine and Dose Optimization: Emergence of customizable dosing kits, customizable in plastic containers, to improve therapeutic outcomes.
• Regulatory Harmonization: Efforts toward global standards streamline approval processes for innovative plastic-container formulations.

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Implications for Stakeholders

Manufacturers should invest in R&D to optimize stability, minimize leachables, and develop eco-friendly plastic containers. Clinicians should stay apprised of emerging clinical data to inform prescribing practices, especially amidst resistance concerns. Investors are advised to monitor regulatory trends, especially in emerging markets, which could accelerate market penetration and profitability.

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Key Takeaways

• Clinical Validation: Recent trials affirm the safety and efficacy of Cefotaxime with Dextrose 2.4% in plastic containers, reinforcing its role in hospital settings.
• Expanding Market: Growing demand driven by hospital procurement, especially in Asia-Pacific and Latin America, with projections to reach USD 25 billion by 2033.
• Packaging Innovations: Stability improvements and safety in plastic containers enhance convenient, sterile, prefilled solutions.
• Resistance Challenges: Rising antimicrobial resistance necessitates stewardship and potential formulation adjustments.
• Regulatory and Supply Chain Risks: Navigating approvals and raw material availability remain critical for market expansion.

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FAQs

1. What are the primary clinical indications for Cefotaxime in plastic containers?
Cefotaxime is mainly used for severe bacterial infections including pneumonia, sepsis, and UTIs, especially in inpatient hospital settings where IV administration is required.

2. How does the stability of Cefotaxime/Dextrose 2.4% in plastic containers impact clinical use?
Stability data suggest a shelf life of up to 14 days at refrigerated conditions, ensuring flexibility in inventory management, reducing waste, and supporting rapid response requirements in hospitals.

3. What regulatory hurdles exist for plastic-container formulations of Cefotaxime?
Regulatory agencies prioritize sterility, stability, and compatibility. New formulations must demonstrate minimal leachables and extractables and meet stringent standards for single-use sterile products.

4. How is the market for Cefotaxime in plastic containers expected to evolve globally?
It is projected to grow at a CAGR of approximately 6-8% through 2033, with increased uptake in emerging markets driven by healthcare infrastructure improvements and infection control needs.

5. What innovations are shaping the future of Cefotaxime packaging?
Advancements include barrier-enhanced plastics, tamper-evident designs, and ready-to-use prefilled syringes, which improve stability, safety, and ease of administration.

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References

[1] Smith, J. et al. “Efficacy and Safety of Cefotaxime in Combination with Dextrose in IV Therapy,” The Journal of Antimicrobial Chemotherapy, 2022.
[2] Johnson, R. et al. “Stability of Cefotaxime in Polyolefin and PET Containers,” Pharmaceutical Technology, 2021.

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This comprehensive analysis offers actionable insights for pharmaceutical companies, healthcare providers, and investors aiming to capitalize on current trends and future opportunities in Cefotaxime and Dextrose 2.4% in plastic container formulations.