CLINICAL TRIALS PROFILE FOR MACROBID

All Clinical Trials for Macrobid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00391651 ↗	Short Course Nitrofurantoin for Acute Cystitis	Completed	Procter and Gamble	Phase 2	2002-01-01	The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance. Procedures subjects will undergo once they have read and signed the consent are: Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine sample and then randomly assigned to one of the two treatment groups. will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time. The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.
NCT00391651 ↗	Short Course Nitrofurantoin for Acute Cystitis	Completed	University of Washington	Phase 2	2002-01-01	The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance. Procedures subjects will undergo once they have read and signed the consent are: Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine sample and then randomly assigned to one of the two treatment groups. will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time. The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.
NCT00649285 ↗	Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg	Completed	Mylan Pharmaceuticals	Phase 1	2002-10-01	The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin monohydrate/macrocrystals capsules to Procter & Gamble's Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.
NCT00734968 ↗	Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence	Completed	Texas A&M University	Phase 4	2008-05-01	This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

Clinical Trial Conditions for Macrobid

Condition Name

Condition Name for Macrobid
Intervention	Trials
Healthy	3
Urinary Tract Infection	3
Urinary Tract Infections	2
Nephrolithiasis	2

Condition MeSH

Condition MeSH for Macrobid
Intervention	Trials
Urinary Tract Infections	8
Infections	5
Infection	4
Communicable Diseases	2

Clinical Trial Locations for Macrobid

Trials by Country

Trials by Country for Macrobid
Location	Trials
United States	18
Canada	1
India	1

Trials by US State

Trials by US State for Macrobid
Location	Trials
West Virginia	2
Washington	2
Pennsylvania	2
California	2
Texas	2

Clinical Trial Progress for Macrobid

Clinical Trial Phase

Clinical Trial Phase for Macrobid
Clinical Trial Phase	Trials
Phase 4	6
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Macrobid
Clinical Trial Phase	Trials
Completed	8
Recruiting	2
Unknown status	1

Clinical Trial Sponsors for Macrobid

Sponsor Name

Sponsor Name for Macrobid
Sponsor	Trials
University of Washington	2
Mylan Pharmaceuticals	2
University of California, San Diego	2

Sponsor Type

Sponsor Type for Macrobid
Sponsor	Trials
Other	21
Industry	4
NIH	1

Current State and Future Projections of Macrobid in the Antibiotic Market

Introduction

Macrobid, a brand name for the antibiotic nitrofurantoin, is widely used for treating urinary tract infections (UTIs). Here, we will delve into recent clinical trials, market analysis, and future projections for Macrobid and the broader antibiotic market.

Clinical Trials Update

Bioequivalence Studies

A recent clinical trial conducted by Mylan aimed to investigate the bioequivalence of Mylan's nitrofurantoin monohydrate/macrocrystals capsules to Procter & Gamble's Macrobid® capsules. This study involved 80 participants and was conducted under fed conditions to assess the bioavailability of the two formulations following a single, oral 100 mg dose. The results of this study are crucial for ensuring that generic versions of Macrobid maintain the same efficacy and safety profile as the branded version[1].

Other Relevant Trials

While there are no recent trials specifically focused on Macrobid, the broader context of antibiotic research is vibrant. For instance, studies on other antibiotics highlight the ongoing efforts to combat antibiotic resistance and develop new therapeutic options. These advancements indirectly influence the market dynamics for established antibiotics like Macrobid[2][5].

Market Analysis

Current Market Size and Growth

The global antibiotic drugs market, which includes Macrobid, is experiencing significant growth. As of 2024, the market is estimated to be valued at $57.36 billion and is projected to reach $73.92 billion by 2029, growing at a CAGR of 4.68% during the forecast period of 2024-2029. This growth is driven by the increasing prevalence of bacterial infections and the critical need for effective antibiotic treatments[2][5].

Market Segmentation

The antibiotic market is segmented by drug class, spectrum, indication, and region. Macrobid falls under the category of narrow-spectrum antibiotics, specifically targeting UTIs. The market analysis includes detailed insights into regions such as the Americas, Europe, Asia Pacific, and the Middle East & Africa, providing a granular understanding of market trends and growth drivers[2][5].

Key Players and Competitive Landscape

Major pharmaceutical companies like Pfizer, GSK PLC, and Merck & Co., Inc. are key players in the antibiotic market. These companies are involved in various strategies including mergers and acquisitions, innovative product developments, and emphasis on antibiotic stewardship to combat antibiotic resistance. The competitive landscape is dynamic, with companies continuously seeking to improve their market position through strategic initiatives[2][5].

Market Projections

Growth Drivers

The escalating prevalence of bacterial infections and the perpetual evolution of antibiotic resistance are primary drivers of the antibiotic market's growth. The need for effective treatments, especially for UTIs, ensures a steady demand for antibiotics like Macrobid. Additionally, advancements in antibiotic stewardship and the development of new therapeutic options contribute to the market's expansion[2][5].

Regional Insights

The market analysis provides a detailed breakdown by region, highlighting the varying growth rates and market sizes. For instance, the Americas and Europe are significant markets, while the Asia Pacific region is expected to show substantial growth due to increasing healthcare expenditure and a rising incidence of bacterial infections[2][5].

Challenges and Opportunities

Despite the growth projections, the antibiotic market faces challenges such as antibiotic resistance and regulatory pressures. However, these challenges also present opportunities for innovation and the development of new antibiotics. The emphasis on sustainable development and addressing antibiotic resistance globally is a critical aspect of the market's future trajectory[2][5].

Strategic Insights for Stakeholders

Market Attractiveness

The report on the global antibiotic drugs market provides insights into market attractiveness, helping stakeholders make informed decisions. The analysis includes a country-wise breakdown, which is essential for understanding local market dynamics and identifying potential investment opportunities[2][5].

Forecast and Trends

The forecast period of 2024-2029 is expected to see significant trends, including the rise of broad-spectrum antibiotics and the increasing focus on narrow-spectrum antibiotics like Macrobid. The report underscores the importance of these trends and their implications for market growth and strategic planning within the pharmaceutical sector[2][5].

Key Takeaways

• Bioequivalence Studies: Recent studies ensure that generic versions of Macrobid maintain the same efficacy and safety as the branded version.
• Market Growth: The global antibiotic market is projected to grow at a CAGR of 4.68% from 2024 to 2029.
• Market Segmentation: Macrobid is part of the narrow-spectrum antibiotic segment, targeting UTIs.
• Competitive Landscape: Major pharmaceutical companies are actively involved in strategic initiatives to improve their market position.
• Growth Drivers: Increasing bacterial infections and the need for effective treatments drive the market's growth.
• Regional Insights: The Americas, Europe, and Asia Pacific are key regions with varying growth rates.

FAQs

Q: What is the current market size of the global antibiotic drugs market?

The global antibiotic drugs market is estimated to be valued at $57.36 billion in 2024[2][5].

Q: What is the projected growth rate of the antibiotic market from 2024 to 2029?

The market is expected to grow at a CAGR of 4.68% from 2024 to 2029[2][5].

Q: Which companies are key players in the antibiotic market?

Key players include Pfizer, GSK PLC, Merck & Co., Inc., and others[2][5].

Q: What are the primary drivers of the antibiotic market's growth?

The escalating prevalence of bacterial infections and the need for effective treatments are primary drivers[2][5].

Q: What challenges does the antibiotic market face, and how do these challenges present opportunities?

The market faces challenges such as antibiotic resistance and regulatory pressures, but these also present opportunities for innovation and the development of new antibiotics[2][5].

Sources

1. Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules: ClinicalTrials.gov.
2. Global Antibiotic Drugs Market Analysis Report 2024: Business Wire.
3. MacroGenics Provides Update on Corporate Progress, First Quarter 2024 Financial Results: MacroGenics.
4. EU Clinical Trials Register: EU Clinical Trials Register.
5. Global Antibiotic Drugs Market Research Report 2024: GlobeNewswire.