Last Updated: November 9, 2026

CLINICAL TRIALS PROFILE FOR MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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All Clinical Trials for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00343317 ↗ Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women Completed Bristol-Myers Squibb N/A 2003-02-01 Postpartum infections are among the leading causes of maternal mortality world-wide, particularly in under-resourced countries. Available data suggests that HIV infected women are at greater risk of postpartum complications than uninfected women. In South Africa, HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths (though indirectly), with puerperal sepsis among the 5 most common causes. This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648) women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36 weeks of gestation during the antenatal period. Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and this morbidity can be reduced by use of prophylactic intrapartum antibiotics.
NCT00343317 ↗ Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women Completed University of KwaZulu N/A 2003-02-01 Postpartum infections are among the leading causes of maternal mortality world-wide, particularly in under-resourced countries. Available data suggests that HIV infected women are at greater risk of postpartum complications than uninfected women. In South Africa, HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths (though indirectly), with puerperal sepsis among the 5 most common causes. This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648) women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36 weeks of gestation during the antenatal period. Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and this morbidity can be reduced by use of prophylactic intrapartum antibiotics.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention Trials
Puerperal Sepsis 1
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Condition MeSH

Condition MeSH for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention Trials
Sepsis 1
HIV Seropositivity 1
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Clinical Trial Locations for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location Trials
South Africa 1
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Clinical Trial Progress for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase Trials
N/A 1
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Clinical Trial Status

Clinical Trial Status for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor Trials
Bristol-Myers Squibb 1
University of KwaZulu 1
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Sponsor Type

Sponsor Type for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor Trials
Industry 1
Other 1
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Last updated: May 7, 2026

MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER: Clinical & Market Update With Forecast

What is the product and how does the “in plastic container, 0.9% NaCl” label affect market access?

“MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER” is a cefotetan (brand name: Mefoxin) reconstitution/dilution presentation supplied for IV use. The key differentiator is the delivery format: mefoxin drug substance provided in or associated with sodium chloride 0.9% and packaged in plastic containers (typical of premixed IV solutions used in hospital workflows).

From a market-access standpoint, the plastic-container format is not a new active ingredient. It changes:

  • Procurement category: often bundled by group purchasing organizations (GPOs) by “IV premix / plastic container” handling standards rather than by vial-only presentations.
  • Compatibility and administration: premix in 0.9% NaCl reduces pharmacy compounding steps and can reduce time-to-admin in high-throughput settings.
  • Parenteral packaging constraints: plastic container supply chains and container-specific QA can drive intermittent availability, especially during container-material sourcing bottlenecks.

Practical outcome: the addressable hospital demand is anchored to cefotetan’s clinical positioning (hospital-treated Gram-negative and anaerobic infections) while the packaged format determines formulary inclusion and pharmacy adoption.


What is the current clinical trial position for cefotetan products?

No reliable, comprehensive, up-to-date clinical trial record specific to the exact presentation name “MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER” is available in the public trial sources used in standard drug intelligence workflows during the last review window. The public clinical pipeline for cefotetan itself is also sparse, consistent with cefotetan being an established antibiotic with limited late-stage development activity versus new-generation cephalosporins.

Implication for decision-making: the product’s near-term clinical trajectory is not driven by ongoing pivotal trials for this presentation. Instead, it is driven by:

  • antibiotic stewardship policies
  • local antibiograms and resistance trends
  • hospital formulary and procurement cycles
  • supply continuity

How is the market likely to perform, given cefotetan’s lifecycle dynamics?

Cefotetan is an older, off-patent cephalosporin. In these categories, pricing and demand are dominated by:

  • Generic penetration (multiple authorized generics and biosimilar-like dynamics do not apply, but generic cefotetan products compete on price)
  • Formulary preferences for broader-spectrum competitors (piperacillin-tazobactam, ceftriaxone, ceftazidime, carbapenems) and newer beta-lactam/beta-lactamase inhibitor agents
  • Hospital antibiotic stewardship that may restrict older broad-spectrum agents unless they match susceptibilities

For a branded/legacy presentation packaged in plastic, sales performance generally tracks:

  • hospital purchasing shifts among institutional delivery formats (vial vs premix)
  • tender cycles and GPO contract awards
  • inventory stability, which can swing usage volumes during shortages

Forward demand behavior (typical for legacy IV antibiotics):

  • Volume stays relatively steady in core indications where guidelines still list cefotetan options
  • Net price trends down, driven by generic substitution and contract renegotiations
  • Market growth is limited unless driven by regional coverage expansions or supply constraints on alternative agents

What indications still drive cefotetan use in hospitals?

Cefotetan (Mefoxin) is used for intra-abdominal and gynecologic infections and perioperative prophylaxis in settings where its spectrum matches institutional protocols. Institutional use persists where clinicians have local evidence of efficacy and where stewardship guidance allows cefotetan as an option.

For this analysis, the practical demand base is inpatient IV antibiotic use, not outpatient.


What is the competitive landscape for a Mefoxin premix/plastic presentation?

Competition is defined primarily by:

  • Other cefotetan presentations (vials and alternative premix packs)
  • Generic cephalosporin substitutes with similar spectrum
  • Beta-lactam/beta-lactamase inhibitor and carbapenem alternatives used for similar infection categories

Key competitive variables:

  • contract pricing
  • availability and delivery lead times
  • pharmacy handling requirements (premix vs compounding)

The plastic-container format can be an advantage for throughput and workflow standardization, but it does not overcome molecule-level generic substitution if contracting favors lower-cost alternatives.


What near-term risks and opportunities affect sales and procurement?

Risks

  • Antibiotic restriction and protocol changes that move away from cefotetan toward other agents
  • Supply chain disruption for either drug substance or the plastic container component
  • Procurement consolidation: GPO awards can shift usage away from branded-style presentations

Opportunities

  • Hospitals standardizing on plastic-container IV admixtures for efficiency and compliance
  • Pharmacy-led conversion to premix formats where compounding workload reduction matters
  • Temporary substitution dynamics when alternatives face shortages, pulling demand toward any available cefotetan supply

Market forecast: sales outlook and volume-probability bands

Because the exact unit sales, geography, and contract-level data for “MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER” are not available in the cited public sources used here, the forecast is expressed as directional bands for the cefotetan institutional market and presentation share rather than as guaranteed revenue numbers.

Cefotetan institutional market outlook (directional, 3-year horizon)

Horizon Expected demand direction Expected net price direction Presentation share effect (plastic premix)
Next 12 months Flat to low growth Down or stable-to-down Stable to modest gains in sites standardizing premix
13 to 24 months Flat Down Slight share gains where plastic container contracts expand
25 to 36 months Flat to slight decline Down Share gains limited by generic-based contract wins

Probabilistic scenario framing (presentation-level)

  • Base case: steady inpatient use where cefotetan remains protocol-eligible; net price erosion continues; plastic premix share holds.
  • Upside case: alternative antibiotic shortages or stewardship protocol flexibility increases cefotetan usage; premix wins incremental formulary slots.
  • Downside case: protocol shifts away from cefotetan and contract awards favor lower-cost non-premix generics.

What should an R&D or investment team monitor for this specific product?

For product-level decisions, the leading indicators are not clinical trial activity but commercial and operational signals:

  • GPO and IDN tender outcomes tied to IV format (plastic premix)
  • regional cefotetan supply availability and lead times
  • formulary updates in major hospital systems (cefotaxtime/cefazolin/cephalosporin substitutes)
  • changes in perioperative prophylaxis protocols affecting cefotetan eligibility
  • antibiotic stewardship restriction statements that mention cefotetan specifically or remove it from order sets

Key Takeaways

  • The “MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER” positioning is primarily a delivery-format and workflow advantage for an established cefotetan molecule, not a driver of new clinical efficacy.
  • Public clinical pipeline activity specific to this exact presentation is not evident; the near-term outlook is driven by institutional protocols, procurement, and supply.
  • Over the next 3 years, the cefotetan institutional market is expected to be flat in volume with net price pressure from generic competition; plastic premix share can move modestly with contract and workflow adoption but does not change the molecule-level competitive reality.

FAQs

1) Does the plastic container change cefotetan clinical performance?

It does not change the active ingredient. It changes administration and workflow characteristics, which can affect hospital adoption and procurement preference but not molecule efficacy.

2) Are there late-stage trials for this exact Mefoxin premix presentation?

No clear, publicly documented late-stage pipeline specific to “MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER” is evident in the standard public trial record sources used for this type of update.

3) What most influences short-term sales: guidelines or pricing?

Both matter, but for this legacy antibiotic, pricing and contracting typically dominate short-term net revenue, while guidelines and order-set eligibility dominate volume.

4) What is the primary customer segment for this product format?

Hospitals and integrated delivery networks that standardize IV admixture workflow, pharmacy handling processes, and perioperative and inpatient antibiotic protocols.

5) What is the main competitive threat?

Generic cefotetan alternatives and competing broad-spectrum IV antibiotics under formulary and stewardship constraints, with procurement contracts deciding which presentation wins.


References

[1] ClinicalTrials.gov. “Search results for cefotetan.” https://clinicaltrials.gov/
[2] DailyMed. “Mefoxin (cefotetan) prescribing information.” https://dailymed.nlm.nih.gov/
[3] FDA. “Drug approvals and labeling information for cefotetan (Mefoxin).” https://www.accessdata.fda.gov/

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