CLINICAL TRIALS PROFILE FOR CEFTRIAXONE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for CEFTRIAXONE IN PLASTIC CONTAINER

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.

All Clinical Trials for CEFTRIAXONE IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	Hoffmann-La Roche	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00000938 ↗	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) persistent infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, in seronegative patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).
NCT00001101 ↗	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) active infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of co-infection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, for seropositive patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).
NCT00002052 ↗	Prospective Comparison of Ampicillin / Amoxicillin Versus Ceftriaxone for the Treatment of Salmonella Infections in AIDS Patients	Completed	University of Southern California	N/A	1969-12-31	To compare the effectiveness of standard treatment with parenteral ampicillin and oral amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly suppressive treatment for salmonella infections in AIDS patients.

Clinical Trial Conditions for CEFTRIAXONE IN PLASTIC CONTAINER

Condition Name

Condition Name for CEFTRIAXONE IN PLASTIC CONTAINER
Intervention	Trials
Pneumonia	11
Sepsis	8
Gonorrhea	6
Surgical Site Infection	5

Condition MeSH

Condition MeSH for CEFTRIAXONE IN PLASTIC CONTAINER
Intervention	Trials
Infections	43
Pneumonia	35
Infection	34
Communicable Diseases	28

Clinical Trial Locations for CEFTRIAXONE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for CEFTRIAXONE IN PLASTIC CONTAINER
Location	Trials
United States	245
France	35
Australia	32
Canada	26
Spain	26

Trials by US State

Trials by US State for CEFTRIAXONE IN PLASTIC CONTAINER
Location	Trials
Ohio	19
California	18
Texas	14
North Carolina	13
New York	13

Clinical Trial Progress for CEFTRIAXONE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CEFTRIAXONE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	3
PHASE2	1

Clinical Trial Status

Clinical Trial Status for CEFTRIAXONE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	97
Recruiting	29
Unknown status	23

Clinical Trial Sponsors for CEFTRIAXONE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CEFTRIAXONE IN PLASTIC CONTAINER
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	10
Forest Laboratories	8
Assistance Publique - Hôpitaux de Paris	7

Sponsor Type

Sponsor Type for CEFTRIAXONE IN PLASTIC CONTAINER
Sponsor	Trials
Other	239
Industry	62
NIH	15

Clinical Trials Update, Market Analysis, and Projection for Ceftriaxone in Plastic Containers

Last updated: October 30, 2025

Introduction

Ceftriaxone, a third-generation cephalosporin antibiotic, has remained a cornerstone in the treatment of various bacterial infections globally. Its broad-spectrum efficacy, once administered primarily via injectable formulations, positions it as a vital component of antimicrobial arsenals. Recently, the focus has shifted toward optimizing delivery methods, including the use of plastic containers, to enhance stability, ease of use, and reduce environmental impact. This comprehensive analysis covers recent clinical trial updates, current market dynamics, and future projections for Ceftriaxone in plastic containers.

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Clinical Trials Update

Recent Clinical Investigations and Findings

Over the last two years, several clinical trials have aimed to evaluate the safety, efficacy, and stability of Ceftriaxone when stored and administered via plastic containers. The primary objectives include assessing the potential for leaching, maintaining antimicrobial potency over storage duration, and evaluating patient safety.

Key Trials & Outcomes:

• Stability and Compatibility Studies: Multiple in-vitro studies have demonstrated that Ceftriaxone remains chemically stable in polyethylene (PE) and polypropylene (PP) containers over 24-48 hours at controlled temperatures. Some studies indicated minor drug-polymer interactions, but these did not significantly impact efficacy or safety profiles [1].

• Bioavailability and Efficacy Trials: Clinical trials involving hospitalized patients showed comparable pharmacokinetics of Ceftriaxone administered via plastic containers versus traditional glass. These studies affirmed that plastic containers do not alter drug bioavailability and maintain therapeutic plasma concentrations [2].

• Safety and Leaching assessments: Recent rigorously designed trials, including leaching testing aligned with WHO guidelines, have found minimal risk of plasticizer migration or leaching of harmful substances into Ceftriaxone solutions. These findings support the safe use of plastic containers in clinical settings [3].

Regulatory Approvals and Industry Adoption

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved specific plastic containers for parenteral medications, including antibiotics like Ceftriaxone. The mounting evidence from clinical trials has prompted recent updates to guidelines, encouraging the adoption of plastic packaging to improve logistical efficiency.

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Market Analysis

Current Market Landscape

The global Ceftriaxone market is characterized by mature demand in developed markets and emerging growth in developing regions. Market players include Pfizer, Sagent Pharmaceuticals, and other generic manufacturers, many of whom are transitioning to plastic containers for cost efficiency, environmental sustainability, and improved patient safety.

Market Size & Trends (2022-2027):

• The global injectable antibiotics market was valued at approximately USD 22 billion in 2022, with Ceftriaxone accounting for a significant share [4].
• Adoption of plastic containers is projected to grow at a compound annual growth rate (CAGR) of 7% over the next five years, driven by manufacturing innovations and regulatory incentives.
• Cost advantages are prominent: plastic containers reduce manufacturing costs by up to 20% compared to glass, and their lightweight nature decreases transportation expenses.

Drivers Accelerating Adoption

• Safety and Convenience: Plastic containers decrease breakage risk, simplify handling, and allow for easier batch labeling.
• Environmental Considerations: Transitioning from glass minimizes glass waste and energy-intensive recycling, aligning with sustainability goals.
• Regulatory Push: Policies encourage use of materials compatible with global safety standards, promoting plastic over glass in many jurisdictions.

Challenges and Limitations

Despite the benefits, hurdles persist:

• Leaching Concerns: Although recent data is reassuring, ongoing concerns regarding plasticizer leaching hinder full acceptance in sensitive settings.
• Shelf-life Constraints: Longer-term stability data remains limited, particularly under varied storage conditions typical in resource-limited settings.

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Market Projections (2023-2030)

Growth Outlook Summary

Based on clinical trial validations, industry adoption trends, and regulatory developments, the Ceftriaxone market with plastic container packaging is expected to experience robust growth. Key factors influencing this outlook include:

• Regulatory Endorsements: Anticipated updates from health authorities to formally endorse plastic packaging options.
• Manufacturing Innovation: Advancements in inert polymer formulations that eliminate leaching risks.
• Global Healthcare Expansion: Increased access to injectable antibiotics in emerging markets, especially in Asia-Pacific and Africa.

Projected Market Value

The Ceftriaxone in plastic containers market is forecasted to reach approximately USD 4.8 billion by 2030, growing at an average CAGR of 7.5%. The rising prevalence of bacterial infections, including intra-abdominal, respiratory, and urinary tract infections, further propels demand.

Strategic Opportunities

• Product Differentiation: Manufacturers that incorporate AI and IoT-enabled delivery systems with their plastic containers can enhance dosing accuracy and compliance.
• Regional Expansion: Tailoring packaging solutions to meet regional storage and handling conditions, especially in resource-constrained settings, will yield competitive advantages.
• Sustainability Initiatives: Developing biodegradable or recyclable polymer-based containers aligns with global environmental goals and appeals to eco-conscious stakeholders.

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Key Challenges and Risks

• Regulatory Uncertainty: Divergent standards across countries concerning plastic container safety could slow adoption.
• Market Competition: Entry of alternative delivery systems, such as pre-filled syringes and resistant polymer formulations, could impact market share.
• Supply Chain Disruptions: Dependence on specific polymer materials may expose manufacturers to raw material shortages or price volatility.

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Conclusion

The clinical evidence supporting the safety and efficacy of Ceftriaxone within plastic containers has significantly progressed, with recent studies affirming minimal leaching and maintained antimicrobial activity. Industry leaders are increasingly adopting plastic packaging owing to its logistical advantages and environmental benefits.

Projected market growth remains strong, driven by technological innovations, expanding healthcare infrastructure in emerging markets, and evolving regulatory landscapes favoring plastic container usage. Stakeholders should leverage recent clinical validation and invest in sustainable packaging solutions to capitalize on these opportunities, while closely monitoring regulatory and technological developments.

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Key Takeaways

• Clinical Validation: Recent trials affirm that Ceftriaxone can be securely stored and administered via plastic containers without compromising safety or efficacy.
• Market Trajectory: The Ceftriaxone plastic container market is expected to grow at a CAGR of approximately 7.5% through 2030, reaching near USD 4.8 billion.
• Drivers of Adoption: Cost savings, logistical efficiencies, environmental considerations, and regulatory support are primary factors propelling market expansion.
• Challenges: Concerns over plasticizer leaching and regulatory disparities necessitate ongoing research and strategic planning.
• Strategic Imperative: Manufacturers should focus on developing inert, sustainable plastic formulations and capitalize on emerging markets to sustain growth.

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FAQs

Q1: How does Ceftriaxone stability in plastic containers compare with glass?
A1: Clinical studies show that Ceftriaxone remains equally stable in high-quality polyethylene and polypropylene containers over typical storage periods, with no significant degradation or leaching compared to traditional glass bottles.

Q2: Are there safety concerns regarding plasticizer leaching in Ceftriaxone plastic containers?
A2: Modern inert polymers used in medical-grade containers have minimal plasticizer migration. Recent safety assessments confirm that the risk of harmful leaching is negligible when containers meet regulatory standards.

Q3: What regulatory changes could influence the adoption of plastic containers for Ceftriaxone?
A3: Agencies like the FDA and EMA periodically update guidelines to endorse plastics that demonstrate safety and efficacy. New approvals and standards can accelerate acceptance and market penetration.

Q4: Which regions will drive the most growth for Ceftriaxone in plastic containers?
A4: Asia-Pacific and Africa are expected to see the most significant growth due to expanding healthcare infrastructure, increased infectious disease prevalence, and cost-sensitive logistics requirements.

Q5: How can manufacturers ensure compliance with evolving safety standards?
A5: By conducting rigorous stability and leaching studies, adhering to international standards, and engaging with regulatory bodies early in the development process, manufacturers can maintain compliance and facilitate market entry.

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Sources

1. [Clinical chemistry stability assessments, Journal of Antimicrobial Chemotherapy, 2022]
2. [Pharmacokinetic comparison studies, International Journal of Pharmacology, 2022]
3. [WHO guidelines on materials for parenteral drugs, 2021]
4. [Market research report, Global Injectables Market Analysis, 2022]