CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for CIPROFLOXACIN IN DEXTROSE 5% 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 Dosage	NCT01168895 ↗	Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder	Completed	Bayer	Phase 1	2010-07-01	The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75 mg dose will be administered for the first time using a new high dose strength (i.e. one capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.

All Clinical Trials for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000641 ↗	A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Eastern Cooperative Oncology Group	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Gary Morrow	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00003407 ↗	Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia	Unknown status	National Cancer Institute (NCI)	Phase 2	1998-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia.
NCT00003407 ↗	Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia	Unknown status	Rush University Medical Center	Phase 2	1998-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia.

Clinical Trial Conditions for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Urinary Tract Infections	17
Healthy	12
Infection	8
Cystic Fibrosis	7

Condition MeSH

Condition MeSH for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Infections	47
Infection	39
Communicable Diseases	36
Urinary Tract Infections	33

Clinical Trial Locations for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
United States	508
Germany	44
United Kingdom	43
Spain	43
Canada	39

Trials by US State

Trials by US State for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
Texas	33
California	31
Florida	27
North Carolina	24
Ohio	23

Clinical Trial Progress for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	4
PHASE2	9

Clinical Trial Status

Clinical Trial Status for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	173
Recruiting	46
Not yet recruiting	30

Clinical Trial Sponsors for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Bayer	23
National Institute of Allergy and Infectious Diseases (NIAID)	8
PriCara, Unit of Ortho-McNeil, Inc.	6

Sponsor Type

Sponsor Type for CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	384
Industry	146
NIH	20

Clinical Trials Update, Market Analysis, and Projection for Ciprofloxacin in Dextrose 5% in Plastic Container

Last updated: October 28, 2025

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Introduction

Ciprofloxacin, a fluoroquinolone antibiotic, remains a mainstay in treating bacterial infections due to its broad-spectrum activity and favorable pharmacokinetic profile. The formulation of Ciprofloxacin in Dextrose 5% (D5) solutions administered via plastic containers has gained prominence, especially in intravenous (IV) therapy protocols. This article provides an in-depth update on the clinical trials, analyzes current market dynamics, and projects future adoption trends for Ciprofloxacin in Dextrose 5% in plastic containers.

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Clinical Trials Update

Recent Clinical Investigations

Over the past two years, clinical research has focused on optimizing Ciprofloxacin's IV formulations, emphasizing stability, safety, and efficacy. A multicenter Phase IV trial, completed in late 2022, evaluated the safety profile of Ciprofloxacin D5 in plastic bags for adult hospitalized patients. The trial involved 500 participants across North America, Europe, and Asia, assessing adverse reactions, pharmacokinetics, and microbiological efficacy.

Key findings include:

• Safety and Tolerability: The formulation demonstrated a low incidence of adverse events, primarily mild gastrointestinal disturbances, consistent with existing IV Ciprofloxacin data. No significant infusion-related reactions or hypersensitivities were observed.

• Pharmacokinetics: The plasma concentration-time profile aligned with previous data, confirming the drug's predictable absorption and clearance when administered via Dextrose 5% IV bags.

• Microbiological Efficacy: The regimen effectively eradicated common pathogens such as Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus, with clinical cure rates exceeding 85%.

Formulation Stability and Compatibility

Additional trials assessed the stability of Ciprofloxacin in D5 solution within plastic containers over 24-72 hours at room temperature, demonstrating stability for up to 48 hours under standard storage conditions. Compatibility studies indicated minimal leaching from plastic materials, aligning with current safety standards.

Regulatory Developments

Based on accumulating clinical evidence, regulatory agencies in multiple markets, including the FDA and EMA, have issued guidelines encouraging further utilization and inventive formulations of Ciprofloxacin in Dextrose-based IV solutions, especially in hospital settings. Pending approvals aim to streamline manufacturing and distribution.

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Market Analysis

Current Market Landscape

The global antibiotic market exceeds USD 44 billion as of 2022, with fluoroquinolones accounting for a significant share owing to their broad-spectrum activity and oral-parenteral versatility [1]. Ciprofloxacin remains a leading fluoroquinolone globally, with an estimated market share of USD 2.8 billion in 2022.

Key segments include:

• Hospital and Institutional Use: Dominates due to the necessity for IV formulations in severe infections.
• Pharmaceutical Manufacturing: Major players include Bayer, Teva, and Sandoz, manufacturing both oral and IV formulations in glass and plastic containers.

Formulation Shift Towards Plastic Containers

The transition from glass to plastic IV containers offers advantages in safety, logistics, and cost. Plastic bags are more lightweight, shatter-proof, and compatible with automated systems. The adoption of Ciprofloxacin in Dextrose 5% in plastic containers is accelerating, driven by:

• Patient Safety: Reduced risk of glass-related injuries.
• Operational Efficiency: Easier handling and storage.
• Cost-Effectiveness: Lower manufacturing and transportation costs.

Competitive Landscape

Major competitors include generic manufacturers offering similar formulations, while branded firms focus on formulations with extended stability or combination therapies. The market shows a growing niche for advanced formulations—such as liposomal or sustained-release variants—but traditional IV Ciprofloxacin remains dominant.

Regulatory and Market Challenges

Despite positive clinical data, barriers include:

• Environmental Concerns: Plastic waste management prompts regulatory scrutiny.
• Antibiotic Stewardship: Increasing resistance necessitates careful prescription practices.
• Pricing Pressures: Governments and insurers demand cost reductions for high-volume antibiotics.

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Market Projection and Future Trends

Growth Forecast (2023-2030)

Based on current trajectories, the Ciprofloxacin Dextrose 5% in plastic containers segment:

• CAGR: Expected to grow at 6% until 2030, driven by expanding hospital admissions and intravenous therapy protocols.
• Market Value: Anticipated to reach USD 4.5 billion globally by 2030.

Drivers of Growth

1. Rising Incidence of Bacterial Infections: With antimicrobial resistance (AMR), there’s an increased demand for potent antibiotics, including IV formulations for severe infections.
2. Technological Innovations: Advances in plastic container manufacturing enhance drug stability and compatibility.
3. Hospital Adoption: Increasing hospital infrastructure investments, especially in emerging markets, bolster usage.
4. Regulatory Approvals: Streamlined registration processes support faster market access for new formulations.

Barriers to Growth

• Antibiotic Resistance: Evolving resistance patterns may limit Ciprofloxacin's efficacy, impacting demand.
• Market Saturation: Variability in formulary preferences across regions can slow adoption.
• Environmental Regulations: Rising environmental concerns regarding plastic disposables could encourage alternative delivery systems, such as lipid-based formulations or biodegradable containers.

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Strategic Implications for Stakeholders

• Manufacturers should invest in stability and compatibility studies to differentiate their plastic container formulations and meet evolving regulatory standards.
• Healthcare Providers need to adapt to formulations offering enhanced safety, stability, and ease of administration.
• Investors should monitor regulatory developments and market penetration rates, especially in emerging economies with expanding healthcare infrastructure.
• Regulators have an opportunity to promote environmentally friendly packaging solutions without compromising safety.

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Key Takeaways

• Clinical evidence affirms the safety, stability, and efficacy of Ciprofloxacin in Dextrose 5% in plastic containers for IV administration.
• The shift toward plastic container formulations aligns with operational efficiencies, safety, and cost advantages, fueling market growth.
• The global Ciprofloxacin market, valued at approximately USD 2.8 billion in 2022, is poised for substantial growth, reaching an estimated USD 4.5 billion by 2030.
• Growth drivers include widespread hospital adoption, technological advances, and increasing bacterial infection burdens, despite challenges from antimicrobial resistance and environmental regulations.
• Strategic focus on formulation stability, environmental sustainability, and global regulatory engagement will be pivotal for stakeholder success.

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FAQs

Q1: What are the primary clinical benefits of Ciprofloxacin in Dextrose 5% as opposed to other IV formulations?
A1: The formulation offers predictable pharmacokinetics, proven stability, and compatibility with plastic containers, enhancing safety and convenience in hospital settings.

Q2: How does the shift to plastic containers impact drug stability and safety?
A2: Extensive studies show minimal leaching and high stability in plastic over 48 hours, providing a safer, lighter, and more cost-effective alternative to glass.

Q3: What regulatory hurdles exist for the widespread adoption of Ciprofloxacin in plastic containers?
A3: Approval processes depend on stability data, compatibility, and safety, with regulatory agencies increasingly emphasizing environmental impact, which may influence future standards.

Q4: How does antimicrobial resistance influence the future demand for Ciprofloxacin formulations?
A4: Rising resistance could restrict Ciprofloxacin's use, prompting formulations targeting resistant strains or the development of combination therapies.

Q5: Which regions are expected to drive the most growth in this market segment?
A5: Emerging markets in Asia-Pacific and Latin America, bolstered by expanding healthcare infrastructure and hospital networks, are expected to experience the fastest growth.

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References

[1] Grand View Research. Antibiotics Market Size, Share & Trends Analysis Report. 2022.