CLINICAL TRIALS PROFILE FOR CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

All Clinical Trials for CEFOTAXIME AND DEXTROSE 3.9% 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cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results).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)
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	Regione Veneto	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 3.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Intervention	Trials
Urinary Tract Infections	4
Spontaneous Bacterial Peritonitis	4
Respiratory Tract Infections	3
Sepsis	3

Condition MeSH

Condition MeSH for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Intervention	Trials
Infections	9
Infection	8
Peritonitis	8
Communicable Diseases	6

Clinical Trial Locations for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Location	Trials
Egypt	8
Spain	6
France	4
Sweden	3
Vietnam	2

Trials by US State

Trials by US State for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Location	Trials
Virginia	1

Clinical Trial Progress for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	14
Phase 3	7

Clinical Trial Status

Clinical Trial Status for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	20
Recruiting	7
Unknown status	6

Clinical Trial Sponsors for CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CEFOTAXIME AND DEXTROSE 3.9% 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 3.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	54
Industry	3
UNKNOWN	1

Last updated: July 28, 2026

Cefotaxime and Dextrose 3.9% in Plastic Container (FDA/Trials/Market Projections)

Executive summary: No complete, reliable dataset can be produced for a “Cefotaxime and Dextrose 3.9% in plastic container” clinical-trials update, market analysis, and projections without verifiable anchors (FDA approval pathway and labeling, NDC/strength-to-form mapping, Orange Book exclusivity/patent status, and trial registry identifiers). Proceeding with any quantified projections, trial readouts, or competitive and IP landscape would require unsupported assumptions that cannot be included.

What clinical trials exist for cefotaxime and dextrose 3.9% in a plastic container?

Featured snippet answer: No trial registry update can be compiled to a “cefotaxime + 3.9% dextrose in plastic container” product label without a specific study identifier and the exact marketed drug configuration (strength, container size/material, and labeling).

Which registries typically include cefotaxime IV combination product trials?

• ClinicalTrials.gov
• EU Clinical Trials Register
• WHO ICTRP-linked records

What endpoints matter for a cefotaxime IV dextrose formulation?

• Pharmacokinetics (Cmax, AUC), stability-driven concentration profiles
• Safety (hypersensitivity, renal tolerance)
• Infusion-site tolerability, compatibility and leachables (when formulation-specific)

What is the FDA regulatory status of cefotaxime plus dextrose 3.9% in plastic containers?

Featured snippet answer: Regulatory status cannot be confirmed to a specific product presentation without an identifiable NDC and label reference.

Is it an NDA, ANDA, or compounding standard?

• Prescription parenteral antibiotics are often sold as approved drug products, but “dextrose concentration in plastic container” can correspond to multiple proprietary presentations and/or distributor-labeled SKUs.

Does the Orange Book list this exact formulation?

• Orange Book listings are presentation-specific; without a verified NDC and reference listed drug (RLD), patent and exclusivity counts cannot be stated.

How many patents protect cefotaxime and dextrose 3.9% IV in plastic containers?

Featured snippet answer: Patent coverage cannot be quantified without tying the presentation to an RLD in the Orange Book and identifying listed patents (drug substance, drug product, and method-of-use).

What patent categories commonly apply to IV cefotaxime combination products?

• Drug substance process patents (active ingredient cefotaxime)
• Drug product patents (formulation, stability, container compatibility)
• Method-of-use patents (rare for older cephalosporins unless new dosing indications exist)
• Manufacturing method patents (sterile fill-finish, aseptic processing, container sealing)

When does cefotaxime and dextrose 3.9% lose exclusivity in the US?

Featured snippet answer: A loss-of-exclusivity timeline cannot be produced without confirmed Orange Book exclusivity types (3-year, 5-year, pediatric, exclusivity for new indications, and patent expiry dates tied to the specific RLD).

What are the usual US exclusivity clocks for older antibiotics?

• Patent expiry often dominates for mature cephalosporin products
• Pediatric exclusivity can extend protection by 6 months on specific labels
• Pediatric review depends on submission timing and exclusivity triggers

What generic entry risks exist for cefotaxime plus 3.9% dextrose in plastic containers?

Featured snippet answer: Paragraph IV risk cannot be evaluated without:

• the relevant RLD,
• Orange Book patent list,
• any ANDA filings and associated litigation/public notices.

What would drive generic market entry?

• Expiry of listed formulation or container-compatibility patents
• Availability of ANDA-ready specs (sterility assurance, container stability)
• Solvency of compatibility constraints for cefotaxime in dextrose solutions

What is the market size for cefotaxime IV in dextrose 3.9% plastic containers?

Featured snippet answer: A defensible market size cannot be stated without specifying the billing unit. “Cefotaxime and dextrose 3.9% in plastic container” is a product presentation; market reports typically aggregate by molecule, route, strength, or NDC ranges.

What commercial data sources are required for a presentation-level forecast?

• IQVIA or similar panel data by NDC/presentation
• FDA CDER drug shortage and distribution data
• Wholesale acquisition cost (WAC) trends by NDC
• Contract manufacturing capacity and conversion rates

How does cefotaxime plus dextrose compare with other cefotaxime IV presentations and competitors?

Featured snippet answer: A rigorous comparison cannot be completed to a presentation-level basis without confirmed competitor and formulation mapping (e.g., cefotaxime in saline vs dextrose, different container systems such as PVC-free vs glass or different fill volumes).

Common substitution dimensions for clinicians and hospitals

• Compatibility with IV fluids and Y-site administration
• Sodium load differences (saline vs dextrose diluent)
• Packaging preference and shortage resilience
• Cost and formulary tier placement

What manufacturing and IP barriers affect supply for cefotaxime IV in plastic containers?

Featured snippet answer: Supply and IP barriers cannot be itemized for this specific presentation without:

• verified manufacturing sites for the product,
• identified container/compatibility patents,
• and confirmed regulatory listing details.

Where supply constraints typically show up for sterile IV cephalosporins

• Sterile fill-finish capacity and aseptic line utilization
• Raw material cefotaxime DS sourcing
• Container component availability and leachables compliance
• Shortage reports and allocation events (if any)

What clinical trial updates should stakeholders watch for this formulation?

Featured snippet answer: No formulation-specific updates can be compiled without a linked trial set for this product presentation.

What types of trials tend to appear for legacy IV antibiotics

• Bioequivalence studies for generic reformulations
• Stability studies that can translate into labeling amendments
• Compatibility studies supporting interchangeability across diluents

Key Takeaways

• A presentation-specific clinical-trials update, FDA/IP status, and market projection for “Cefotaxime and Dextrose 3.9% in plastic container” cannot be produced to an actionable standard without verifiable identifiers that map to the exact FDA-listed product and its filings.
• Proceeding with quantified projections or exclusivity/patent conclusions would require unsupported assumptions and cannot be included.

FAQs

1. How can I confirm whether “cefotaxime + 3.9% dextrose” is a specific FDA RLD presentation or a distributor-labeled SKU?
2. Are there known formulation patents for cefotaxime IV dextrose solutions tied to container material or stability?
3. What signals on ClinicalTrials.gov would indicate formulation-specific studies rather than generic bioequivalence only?
4. How do hospital formulary decisions differ between cefotaxime in dextrose vs saline-based IV preparations?
5. What documentation is typically needed to support an ANDA for an IV cephalosporin with a specific dextrose concentration and plastic container?

References

1. None cited.