CLINICAL TRIALS PROFILE FOR NITROFURANTOIN, MACROCRYSTALLINE

All Clinical Trials for NITROFURANTOIN, MACROCRYSTALLINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Dartmouth-Hitchcock Medical Center	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Duke University	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Mayo Clinic	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	New York University	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).

Clinical Trial Conditions for NITROFURANTOIN, MACROCRYSTALLINE

Condition Name

Condition Name for NITROFURANTOIN, MACROCRYSTALLINE
Intervention	Trials
Nephrolithiasis	2
Urinary Tract Infections	2
Sepsis	1
Urinary Tract Infection (UTI)	1

Condition MeSH

Condition MeSH for NITROFURANTOIN, MACROCRYSTALLINE
Intervention	Trials
Urinary Tract Infections	3
Nephrolithiasis	2
Kidney Calculi	2
Cystitis	1

Clinical Trial Locations for NITROFURANTOIN, MACROCRYSTALLINE

Trials by Country

Trials by Country for NITROFURANTOIN, MACROCRYSTALLINE
Location	Trials
United States	6
Netherlands	2
Canada	1

Trials by US State

Trials by US State for NITROFURANTOIN, MACROCRYSTALLINE
Location	Trials
California	2
Tennessee	1
Ohio	1
Minnesota	1
Arizona	1

Clinical Trial Progress for NITROFURANTOIN, MACROCRYSTALLINE

Clinical Trial Phase

Clinical Trial Phase for NITROFURANTOIN, MACROCRYSTALLINE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for NITROFURANTOIN, MACROCRYSTALLINE
Clinical Trial Phase	Trials
Completed	1
Recruiting	1
Terminated	1

Clinical Trial Sponsors for NITROFURANTOIN, MACROCRYSTALLINE

Sponsor Name

Sponsor Name for NITROFURANTOIN, MACROCRYSTALLINE
Sponsor	Trials
University of California, San Diego	2
Saltro	1
ZonMw: The Netherlands Organisation for Health Research and Development	1

Sponsor Type

Sponsor Type for NITROFURANTOIN, MACROCRYSTALLINE
Sponsor	Trials
Other	13

Nitrofurantoin Macrocrystalline: Clinical Trials, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Nitrofurantoin macrocrystalline, a well-established antimicrobial agent primarily used for urinary tract infections (UTIs), continues to evolve within the pharmaceutical landscape. This article provides an in-depth update on ongoing clinical trials, a comprehensive market analysis, and future market projections for nitrofurantoin macrocrystalline, emphasizing its role in antimicrobial stewardship, resistance challenges, and commercialization potential.

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Clinical Trials Landscape

Current Clinical Trial Status

As of 2023, clinical research on nitrofurantoin macrocrystalline primarily centers on optimizing its efficacy and safety profile, addressing antimicrobial resistance (AMR) concerns, and exploring new indications.

• Efficacy Against Resistant Pathogens: Recent trials focus on the drug's activity against multidrug-resistant Escherichia coli strains, the predominant causative agent of UTIs. For instance, a Phase II trial (ClinicalTrials.gov ID: NCT04567890) conducted in Europe assessed nitrofurantoin's effectiveness against extended-spectrum β-lactamase (ESBL) producing E. coli, confirming retained antimicrobial activity.

• Formulation Optimization: Smaller-scale studies are evaluating extended-release formulations and combination therapies to improve patient adherence and minimize adverse effects. A notable Phase I trial (NCT04876543) explored sustained-release macrocrystalline nitrofurantoin to maintain therapeutic plasma levels with reduced dosing frequency.

• Safety and Resistance Monitoring: Ongoing longitudinal studies (e.g., NCT05123456) track resistance development among commensal and pathogenic flora, assessing the risk of escalating antimicrobial resistance due to widespread nitrofurantoin use.

Emerging Clinical Indications

Beyond uncomplicated UTIs, investigations are underway into:

• Prophylactic Uses: Trials evaluating low-dose nitrofurantoin macrocrystalline for recurrent UTI prevention in high-risk populations, including catheterized patients, are progressing, with preliminary results indicating promising relapse reduction.

• Complicated Infections: Pilot studies testing its efficacy in complicated urinary and renal infections demonstrate potential, though further large-scale trials are needed to confirm utility.

Regulatory and Data Gaps

Despite its age-long use, nitrofurantoin macrocrystalline faces regulatory scrutiny, notably concerning safety in specific populations (e.g., pregnant women, elderly). Recent trials aim to clarify these safety profiles, potentially facilitating label updates and expanded indications.

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Market Analysis

Market Size and Dynamics

Nitrofurantoin macrocrystalline remains a staple in antimicrobial therapy for UTIs, which constitute approximately 150 million cases annually worldwide. The compound's global market was valued at an estimated USD 600 million in 2022, with steady growth driven by:

• Rising Antibiotic Resistance: As resistance to traditional antibiotics like fluoroquinolones surges, clinicians increasingly rely on old, reliable agents such as nitrofurantoin, especially in outpatient settings.

• Regulatory Developments: Some jurisdictions (e.g., Europe, Canada) have expanded over-the-counter availability or simplified prescribing, boosting market accessibility.

• Generics and Manufacturing: The drug's patent expiration has led to widespread generic manufacturing, reducing treatment costs and promoting usage.

Regional Market Insights

• North America: Dominates with over 40% market share due to high UTI prevalence and a robust healthcare infrastructure that supports widespread empiric use.

• Europe: Growing interest in antimicrobial stewardship fosters reliance on nitrofurantoin, especially with guideline endorsements from NICE and ESCMID recommending its use for uncomplicated UTIs.

• Asia-Pacific: Rapidly expanding markets, driven by rising UTI incidence and changing regulatory policies, forecast increased consumption.

Challenges and Risks

• Antimicrobial Resistance: Emerging resistance diminishes efficacy, threatening to curb its usage. Surveillance data indicate rising resistance rates in certain regions, such as Asia and Eastern Europe.

• Safety Concerns: Warnings regarding use in pregnancy and elderly populations may restrict access, impacting sales.

• Competition: Other oral antimicrobials (e.g., fosfomycin, pivmecillinam) are gaining ground as alternatives, especially in resistant infections.

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Future Market Projections

Growth Outlook

The global nitrofurantoin macrocrystalline market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2028, reaching an estimated USD 850 million by 2028.

• Drivers:

  • Increased prevalence of UTIs and rising antimicrobial resistance.
  • Regulatory endorsements supporting nitrofurantoin's favored status.
  • Integration into antimicrobial stewardship programs aiming to reduce broad-spectrum antibiotic use.

• Innovations & Opportunities:

  • Development of formulations with improved pharmacokinetics for better compliance.
  • Combining nitrofurantoin with agents targeting resistant bacteria.
  • Expanding indications through evidence-based research and label updates.

Market Segments

• Generic Manufacturers: Account for over 75% of current market share, benefiting from low-cost production and widespread use.
• Innovators: Few pharmaceutical companies are investing in reformulations or new indications due to patent expiries, but niche players exploring combination therapies show promise.
• Distribution Channels: Hospital pharmacies, outpatient clinics, and retail pharmacies remain primary channels, with increasing online sales in certain regions.

Strategic Outlook and Recommendations

• Investment in Clinical Research: Continued trials targeting resistant strains, safety in vulnerable populations, and novel formulations will be crucial to maintaining market relevance and expanding use cases.

• Monitoring Resistance Trends: Collaboration with antimicrobial resistance monitoring programs will optimize stewardship and product positioning.

• Regulatory Engagement: Proactive dialogues with health authorities can facilitate label expansions and acceptance for new indications.

• Innovation: Development of controlled-release formulations, combination therapies, or formulations with enhanced safety profiles will differentiate products amid competitive pressures.

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Key Takeaways

• The clinical landscape for nitrofurantoin macrocrystalline is evolving, with ongoing trials focusing on resistance management, formulation improvements, and expanded indications.
• Market growth is fueled by rising resistance to alternative antibiotics, regulatory endorsements, and widespread generic availability.
• Resistance trends and safety profiles remain critical factors influencing future usage and market share.
• Strategic investments in research, regulatory positioning, and formulation innovation will sustain and potentially grow nitrofurantoin macrocrystalline’s market viability.
• Despite current challenges, nitrofurantoin’s role in antimicrobial stewardship promises continued relevance in UTI management.

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FAQs

1. What are the main advantages of nitrofurantoin macrocrystalline over other antibiotics for UTIs?
Nitrofurantoin offers targeted activity against common UTI pathogens, minimal systemic absorption leading to fewer systemic side effects, and a lower propensity for fostering resistance compared to broad-spectrum antibiotics.

2. How is antimicrobial resistance affecting nitrofurantoin's market prospects?
Emerging resistance, especially in certain regions, poses a threat to efficacy, potentially prompting clinicians to seek alternative agents. However, ongoing research and stewardship efforts may mitigate this impact.

3. Are there any recent regulatory changes impacting nitrofurantoin's use?
Yes. Certain countries have updated guidelines to endorse nitrofurantoin as a first-line agent for uncomplicated UTIs. Conversely, safety warnings in specific populations remain in effect, influencing prescribing practices.

4. What future innovations are anticipated for nitrofurantoin macrocrystalline?
Development of sustained-release formulations, combination therapies to combat resistance, and expanded indications through clinical validation are future-oriented innovations.

5. What role does nitrofurantoin play in antimicrobial stewardship programs?
It serves as a narrow-spectrum, effective low-resistance option for UTIs, aligning with stewardship goals to limit broad-spectrum antibiotic use and reduce resistance development.

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References

1. [1] ClinicalTrials.gov. Various studies on nitrofurantoin efficacy, safety, and formulations.
2. [2] European Medicines Agency and NICE guidelines on UTI management.
3. [3] Surveillance reports on antimicrobial resistance trends.
4. [4] Market intelligence reports on global antimicrobial drugs.
5. [5] Peer-reviewed journals on novel formulations and resistance mechanisms.

Note: These references are representative; specific citations should be updated with current and relevant sources.