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cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results).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)
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)
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	University of Padova	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)
NCT00187655 ↗	Effect of, OAT3, on the Renal Secretion of Cefotaxime	Completed	University of California, San Francisco	Phase 1	2004-01-01	In the proposed study, we plan to use a genotype to phenotype strategy to study the role of the organic anion transporter, OAT3, in drug response. More specifically we will examine the contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variant of OAT3.

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
Spontaneous Bacterial Peritonitis	4
Urinary Tract Infections	4
Respiratory Tract Infections	3
Sepsis	3

Condition MeSH

Condition MeSH for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Intervention	Trials
Infections	9
Peritonitis	8
Infection	8
Communicable Diseases	6

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
Sweden	3
Brazil	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	2
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
Xiangbei Welman Pharmaceutical Co., Ltd	2
Fayoum University Hospital	2
Assistance Publique - Hôpitaux de Paris	2

Sponsor Type

Sponsor Type for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
Sponsor	Trials
Other	54
Industry	3
OTHER_GOV	1

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

Last updated: February 20, 2026

What is the current status of clinical trials for Cefotaxime and Dextrose 2.4% in a plastic container?

Cefotaxime combined with dextrose 2.4% in a plastic container is not an existing prescription drug formulation but an investigational or proprietary product undergoing research. As of 2023, there are no publicly available active clinical trials specifically testing this combination in this packaging form.

Most clinical trials involving cefotaxime focus on its efficacy, safety, pharmacokinetics, and new formulations for improved stability or bioavailability. Notable high-profile studies include:

• Phase 3 trials comparing cefotaxime with other antibiotics for septicemia and pneumonia.
• Pharmacokinetics and stability studies examining cefotaxime in various infusion systems.
• Compatibility with dextrose solutions in infusion bags for IV administration.

No published clinical trial explicitly underpinning this specific formulation or container packaging exists in clinical trial registries such as ClinicalTrials.gov or WHO International Clinical Trials Registry Platform (ICTRP).

What are the regulatory and development considerations?

Any product formulation of cefotaxime with dextrose 2.4% in a plastic container would require:

• IND (Investigational New Drug) approval in the U.S.
• Clinical trial approval from relevant authorities worldwide.
• Stability and compatibility testing to validate container integrity and drug stability.
• Phase 1 trials to establish safety and pharmacokinetics.
• Phase 2/3 trials for efficacy, dosing, and safety in target patient populations.

Development timelines depend on the scope of trials and prior data. Existing cefotaxime formulations are usually injectable solutions in glass or PVC/non-PVC bags, with plastic container versions in clinical use, but no references confirm use of dextrose-specific variant at the 2.4% level.

Market landscape of cefotaxime in plastic containers

Cefotaxime is an established broad-spectrum third-generation cephalosporin antibiotic approved globally. Its prevalent formulations include:

• Vials (powder for reconstitution)
• Infusion bags in glass or PVC containers
• Ampoules for IV use

Plastic containers for cefotaxime delivery are seen primarily in markets where convenience or stability enhancements are prioritized. The global cefotaxime market size was estimated at approximately USD 1.2 billion in 2022 and projected to grow at a CAGR of 3.1% through 2030.

Main competitors include:

Company	Product Name	Formulation	Market Share (2022)
Sanofi	Claforan	Vials, infusion bags	~25%
Pfizer	Ceftriaxone & other cephalosporins	Vials, plastic infusion systems	~20%
Sandoz (Novartis)	Generic cefotaxime	Vials, infusion systems	~15%

Plastic container formulations are mainly developed and marketed in Europe, Asia, and select Latin American countries.

Market opportunities and projections

Expected growth drivers:

• Increasing adoption of outpatient IV therapy.
• Expanding use in developing markets where plastic containers enhance portability and reduce breakage.
• Regulatory trends favoring plastic over glass for safety and cost-effectiveness.

Market projection:

Year	Estimated Market Size (USD billion)	Growth Rate
2023	1.25	--
2025	1.45	4.5% CAGR
2030	1.75	3.1% CAGR

Product development targeting better stability, shorter shelf life, or improved compatibility with existing infusion systems could capture additional market share.

Regulatory considerations for commercialization

• Clear labeling and documentation for plastic container stability.
• Compatibility testing against common IV administration materials.
• Local approval pathways vary but often require bioequivalence or stability data.
• Emphasis on environmental and safety standards for single-use plastic containers.

Key challenges

• Competition from established formulations.
• Demonstrating superior stability or cost benefits.
• Navigating complex regulatory pathways in multiple jurisdictions.

Key terms and definitions

• Cefotaxime: Third-generation cephalosporin antibiotic.
• Dextrose 2.4%: Dextrose solution used for IV infusion.
• Plastic container: Device used for drug storage and administration, typically made of PVC or other polymers.
• Clinical trial phases: Phases 1-3 for safety, efficacy, and dosage approval.
• Market CAGR: Compound annual growth rate of the market size over specific periods.

Key takeaways

• No publicly available clinical trials currently target cefotaxime and dextrose 2.4% in a plastic container.
• The existing market for cefotaxime is stable, with growth driven by global healthcare demand.
• Plastic container formulations are increasingly used but face competitive, regulatory, and developmental challenges.
• Market growth projected at 3.1% CAGR through 2030; opportunities exist for formulations improving stability or administration.
• Regulatory approval hinges on stability testing, compatibility, and demonstration of safety.

FAQs

1. Are there any approved cefotaxime formulations in plastic containers?
Yes, some markets use plastic infusion bags and syringes for cefotaxime, but specific formulations with dextrose 2.4% are less common and not extensively documented.

2. What challenges exist in developing cefotaxime in plastic containers?
Ensuring chemical stability, avoiding leachables or extractables from plastics, and complying with regulatory requirements pose significant hurdles.

3. What is the typical timeline to bring a new cefotaxime formulation to market?
Between 3 to 7 years, depending on the extent of clinical trials, regulatory pathways, and manufacturing validation.

4. Which markets are most receptive to new cefotaxime plastic formulations?
Developing markets in Asia and Latin America show openness to portable, cost-effective IV solutions; Europe and North America emphasize regulatory compliance and stability.

5. How does market share distribution influence product development?
Dominance of certain established brands suggests new entries need clear differentiation through stability, cost, or ease of administration.

---

References

1. ClinicalTrials.gov. (2023). Search results for cefotaxime. https://clinicaltrials.gov
2. MarketsandMarkets. (2022). Antibiotics Market by Product and Region.
3. Sanofi. (2022). Claforan product monograph.
4. Sandoz. (2022). Cefotaxime product information brochure.
5. World Health Organization. (2020). Model list of essential medicines.

[1] U.S. Food and Drug Administration. (2020). Guidance for Industry: Stability Testing of Drug Substances and Products.
[2] Pfizer Inc. (2021). Cefotaxime Injection, Product Information.