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.
NCT00003824 ↗	S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer	Terminated	National Cancer Institute (NCI)	Phase 3	1999-04-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.

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	16
Healthy	12
Infection	8
Crohn's Disease	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	31

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	504
Germany	44
United Kingdom	43
Spain	41
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
New York	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
Phase 4	65
Phase 3	66
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Ciprofloxacin In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	169
Recruiting	35
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	360
Industry	143
NIH	20

Ciprofloxacin in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction

Ciprofloxacin, a broad-spectrum antibiotic, is widely used to treat various bacterial infections. When administered in a dextrose solution, it is often used for intravenous therapy. Here, we will delve into the latest clinical trials, market analysis, and future projections for ciprofloxacin in dextrose 5% in plastic containers.

Clinical Trials Update

RESPIRE Trials

One of the significant clinical trials involving ciprofloxacin, although not specifically in dextrose solution, is the RESPIRE trials. These trials focus on ciprofloxacin dry powder for inhalation (DPI) to reduce exacerbations in patients with non-cystic fibrosis bronchiectasis (NCFB). The RESPIRE 1 trial, a phase III placebo-controlled randomized trial, evaluated the efficacy and safety of intermittent ciprofloxacin DPI regimens over 48 weeks. Patients were randomized to receive either ciprofloxacin DPI or placebo in cycles of 14 or 28 days on/off. The trial aimed to prolong the time to the first exacerbation and reduce the frequency of exacerbations. While this trial does not directly involve ciprofloxacin in dextrose, it highlights the ongoing research and development efforts to expand the therapeutic applications of ciprofloxacin[1].

Combination Therapies

Another clinical trial worth noting is the one that evaluated the efficacy and safety of ciprofloxacin plus fluocinolone acetonide. This randomized clinical trial involved 493 patients and compared the therapeutic outcomes of ciprofloxacin plus fluocinolone against each agent alone. The results showed that the combination therapy was not significantly superior to ciprofloxacin alone for the primary outcome at visit 3 but was superior at visit 4 in some populations. This study, while not directly related to the dextrose formulation, underscores the continuous exploration of ciprofloxacin's therapeutic potential in various combinations[4].

Market Analysis

Global Market Trends

The global ciprofloxacin market is anticipated to witness significant growth. According to market research reports, the ciprofloxacin market is expected to grow at a positive compound annual growth rate (CAGR) from 2024 to 2031. The market size and revenue share are analyzed at the global, regional, and country levels, providing a comprehensive overview of the industry trends and market dynamics[5].

Key Players and Market Share

Major players in the ciprofloxacin market include SUN PHARM, Kores India, DR REDDYS LABS, Bayer AG, Aurobindo Pharma, Quimica Sintetica, and Neuland Laboratories. These companies are driving the market through strategic collaborations, mergers and acquisitions, and innovative product developments. The market share analysis highlights the competitive landscape and the dominance of these key players[2].

Regional Analysis

The ciprofloxacin market is segmented into major regions such as North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region's revenue share and current trends are analyzed to provide a detailed understanding of the market's geographical distribution. This segmentation helps in identifying high-growth regions and opportunities for market expansion[5].

Market Projections

Forecast Period

The forecast period for the ciprofloxacin market extends from 2025 to 2031. During this period, the market is expected to grow driven by increasing demand for antibiotics, rising healthcare expenditures, and advancements in pharmaceutical technology. The report provides detailed forecasts, including market size, revenue, and CAGR, which are essential for strategists, marketers, and senior management to make informed decisions[5].

Drivers and Opportunities

The growth of the ciprofloxacin market is driven by several factors, including the increasing prevalence of bacterial infections, the need for effective antibiotic treatments, and the expanding healthcare infrastructure in developing countries. Additionally, the rise in research and development activities aimed at improving antibiotic efficacy and reducing resistance is expected to drive market growth[5].

Challenges and Restraints

Despite the positive outlook, the ciprofloxacin market faces challenges such as antibiotic resistance, stringent regulatory requirements, and the potential for side effects. These factors can impact market growth and necessitate continuous innovation and regulatory compliance[5].

Administration and Storage of Ciprofloxacin in Dextrose 5%

Preparation and Administration

Ciprofloxacin in dextrose 5% is typically administered intravenously. The solution must be prepared according to the manufacturer's instructions, ensuring the correct dilution and storage conditions. For example, ciprofloxacin oral suspension, though different in formulation, requires vigorous shaking before use and should not be frozen[3].

Storage Conditions

The reconstituted solution of ciprofloxacin in dextrose 5% must be stored under specific conditions to maintain its stability. It should be kept below 30 degrees C (86 degrees F) and not frozen. Proper storage is crucial to ensure the efficacy and safety of the medication[3].

Key Takeaways

• Clinical Trials: Ongoing trials like the RESPIRE trials and combination therapy studies highlight the continuous effort to expand ciprofloxacin's therapeutic applications.
• Market Growth: The global ciprofloxacin market is projected to grow significantly from 2025 to 2031, driven by increasing demand and advancements in pharmaceutical technology.
• Key Players: Major pharmaceutical companies are driving the market through strategic collaborations and innovative product developments.
• Regional Analysis: The market is segmented into major regions, with each region's revenue share and trends analyzed to identify growth opportunities.
• Administration and Storage: Proper preparation, administration, and storage of ciprofloxacin in dextrose 5% are crucial for its efficacy and safety.

FAQs

What is the current status of the RESPIRE trials for ciprofloxacin DPI?

The RESPIRE trials are phase III clinical trials evaluating the efficacy and safety of ciprofloxacin DPI in reducing exacerbations in patients with non-cystic fibrosis bronchiectasis. The results of the RESPIRE 1 trial have been reported, showing the impact of intermittent ciprofloxacin DPI regimens on exacerbation frequency[1].

Who are the key players in the global ciprofloxacin market?

Key players include SUN PHARM, Kores India, DR REDDYS LABS, Bayer AG, Aurobindo Pharma, Quimica Sintetica, and Neuland Laboratories. These companies are significant due to their market share, strategic collaborations, and innovative product developments[2].

What are the forecasted growth rates for the ciprofloxacin market from 2025 to 2031?

The ciprofloxacin market is expected to grow at a positive CAGR from 2025 to 2031, driven by increasing demand for antibiotics and advancements in pharmaceutical technology. The exact CAGR is provided in detailed market reports[5].

How should ciprofloxacin in dextrose 5% be stored?

The reconstituted solution of ciprofloxacin in dextrose 5% should be stored below 30 degrees C (86 degrees F) and should not be frozen to maintain its stability[3].

What are the main drivers of the ciprofloxacin market growth?

The growth is driven by the increasing prevalence of bacterial infections, the need for effective antibiotic treatments, and the expanding healthcare infrastructure in developing countries. Additionally, advancements in pharmaceutical technology and research aimed at improving antibiotic efficacy contribute to market growth[5].

Sources

1. ERS Publications: "RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in patients with non-cystic fibrosis bronchiectasis."
2. OpenPR: "Global Ciprofloxacin HCl Market Is Likely to Witness Tremendous Growth by 2025."
3. PDR.net: "Cipro - Drug Summary."
4. JAMA Network: "Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide."
5. Cognitive Market Research: "Ciprofloxacin Market Report 2024 (Global Edition)."