CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN HYDROCHLORIDE

505(b)(2) Clinical Trials for CIPROFLOXACIN HYDROCHLORIDE

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 HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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).

Clinical Trial Conditions for CIPROFLOXACIN HYDROCHLORIDE

Condition Name

Condition Name for CIPROFLOXACIN HYDROCHLORIDE
Intervention	Trials
Urinary Tract Infections	16
Healthy	12
Infection	8
Cystic Fibrosis	7

Condition MeSH

Condition MeSH for CIPROFLOXACIN HYDROCHLORIDE
Intervention	Trials
Infections	47
Infection	39
Communicable Diseases	36
Urinary Tract Infections	31

Clinical Trial Locations for CIPROFLOXACIN HYDROCHLORIDE

Trials by Country

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−

Trials by Country for CIPROFLOXACIN HYDROCHLORIDE
Location	Trials
United States	504
Germany	44
United Kingdom	43
Spain	41
Canada	39

Trials by US State

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−

Trials by US State for CIPROFLOXACIN HYDROCHLORIDE
Location	Trials
Texas	33
California	31
Florida	27
North Carolina	24
Ohio	23

Clinical Trial Progress for CIPROFLOXACIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CIPROFLOXACIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	65
Phase 3	66
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for CIPROFLOXACIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	169
Recruiting	35
Not yet recruiting	30

Clinical Trial Sponsors for CIPROFLOXACIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for CIPROFLOXACIN HYDROCHLORIDE
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 HYDROCHLORIDE
Sponsor	Trials
Other	360
Industry	143
NIH	20

Ciprofloxacin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Ciprofloxacin Hydrochloride

Ciprofloxacin hydrochloride, a member of the fluoroquinolone family of antibiotics, is widely recognized for its broad-spectrum efficacy against both Gram-positive and Gram-negative bacteria, as well as various other microorganisms. This antibiotic is used to treat a range of bacterial infections, including urinary tract infections (UTIs), skin and soft tissue infections, respiratory tract infections, and intra-abdominal infections.

Clinical Trials and Efficacy

Pharmacodynamic Profiling

Recent studies have focused on the pharmacodynamic profiling of ciprofloxacin, particularly in treating urinary tract infections caused by ceftriaxone-resistant Escherichia coli. These studies involve dynamic bladder infection models to simulate different dosing regimens of oral ciprofloxacin. The results indicate that for susceptible isolates (MIC ≤ 0.25 mg/L), a dosing regimen of 250 mg every 12 hours is effective, while for isolates with MIC ≤ 1 mg/L, a regimen of 750 mg every 12 hours promotes significant bacterial killing[1].

Clinical Experience

A comprehensive analysis of 146 clinical trials involving oral ciprofloxacin has demonstrated its efficacy and safety. These trials, which included 3,981 patients, showed that ciprofloxacin at dosages ranging from 250 to 750 mg every 12 hours was effective in treating various infections. Ciprofloxacin was found to be as effective as other standard therapeutic agents, such as trimethoprim/sulfamethoxazole and cefotaxime, in treating urinary tract and skin infections. It also showed superior results in eradicating causative organisms in respiratory tract infections compared to ampicillin[4].

Adverse Reactions and Resistance

While ciprofloxacin is generally well-tolerated, adverse reactions were reported in 16.2% of the patients treated, with most being mild or moderate and resolving after therapy completion. However, the emergence of resistant organisms associated with ciprofloxacin therapy has been a concern, though it is reported infrequently[4].

Market Analysis

Global Market Size and Growth

The global ciprofloxacin hydrochloride market is projected to grow significantly over the next decade. From a market size of USD 970.53 million in 2023, it is expected to reach USD 1684.78 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.32% during the forecast period (2024-2032)[2].

Regional Insights

The Asia Pacific region is anticipated to dominate the market during the forecast period, driven by the high prevalence of bacterial infections and the need for effective antibiotics. Other significant markets include the United States, Europe, China, Japan, India, and Brazil[2][3].

Applications and Types

Ciprofloxacin hydrochloride is used in various applications, with urinary tract infections, respiratory tract infections, and gastrointestinal infections being major segments. The drug is available in multiple formulations, including 0.25 g, 0.5 g, and 1 g per capsule or tablet, which enhances patient compliance[2][3].

Market Dynamics

Drivers

The market growth is driven by several factors, including the increasing prevalence of bacterial infections such as gastroenteritis and bacterial enteric infections. The versatility of ciprofloxacin in addressing a wide spectrum of bacteria and its proven clinical efficacy make it a preferred choice for healthcare professionals. Additionally, the convenience of multiple formulations and the constant threat of foodborne illnesses contribute to the demand for ciprofloxacin hydrochloride[2].

Limitations and Opportunities

Despite its efficacy, the emergence of antibiotic-resistant strains poses a significant challenge. However, this also presents opportunities for ongoing research and development to improve the drug's effectiveness and to explore new applications. The market is also influenced by regulatory changes, technological advancements, and consumer preferences[3].

Competitive Landscape

The global ciprofloxacin hydrochloride market is competitive, with several key players involved in the production and distribution of the drug. Market share is distributed among various types and applications, with a focus on expanding product lines and improving distribution networks. Strategic mergers, acquisitions, and new investments are common in this market, aiming to enhance market presence and respond to growing demand[3].

Forecast and Projections

Consumption Volume and Revenue

The global ciprofloxacin hydrochloride market is expected to see significant growth in both consumption volume and revenue. The forecast indicates an increase in consumption volume and revenue across different regions, with the Asia Pacific region leading the growth. The price trends are expected to remain stable, with potential fluctuations based on market dynamics and regulatory changes[3].

Regional Growth

Regional forecasts suggest that the Asia Pacific, followed by the United States and Europe, will be the key drivers of market growth. The growth in these regions is attributed to the increasing incidence of bacterial infections and the need for effective antibiotic treatments[2][3].

Key Takeaways

• Efficacy and Safety: Ciprofloxacin hydrochloride has been proven effective in treating a broad spectrum of bacterial infections, with a favorable safety profile.
• Market Growth: The global market is projected to grow at a CAGR of 6.32% from 2023 to 2032.
• Regional Dominance: The Asia Pacific region is expected to dominate the market during the forecast period.
• Applications: The drug is widely used in treating urinary tract infections, respiratory tract infections, and gastrointestinal infections.
• Challenges and Opportunities: The emergence of antibiotic-resistant strains is a challenge, but it also presents opportunities for research and development.

FAQs

What is ciprofloxacin hydrochloride used for?

Ciprofloxacin hydrochloride is used to treat various bacterial infections, including urinary tract infections, skin and soft tissue infections, respiratory tract infections, and intra-abdominal infections.

What are the common dosages of ciprofloxacin hydrochloride?

Common dosages range from 250 mg to 750 mg every 12 hours, depending on the type and severity of the infection.

What are the potential side effects of ciprofloxacin hydrochloride?

Adverse reactions include mild to moderate intensity effects such as nausea, diarrhea, and abdominal pain, which typically resolve after therapy completion.

How is the global market for ciprofloxacin hydrochloride expected to grow?

The global market is expected to grow from USD 970.53 million in 2023 to USD 1684.78 million by 2032, at a CAGR of 6.32%.

Which region is expected to dominate the ciprofloxacin hydrochloride market?

The Asia Pacific region is anticipated to dominate the market during the forecast period due to the high prevalence of bacterial infections and the need for effective antibiotics.

Sources

1. Oral ciprofloxacin activity against ceftriaxone-resistant Escherichia coli isolates - Journal of Antimicrobial Chemotherapy[1]
2. Ciprofloxacin HCl Market - Overview and Outlook - Introspectivemarketresearch.com[2]
3. Global Ciprofloxacin Hcl Consumption Market Research Report - Maiaresearch.com[3]
4. Ciprofloxacin: an update on clinical experience - PubMed[4]