CLINICAL TRIALS PROFILE FOR AZTREONAM

All Clinical Trials for aztreonam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00104520 ↗	Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa	Completed	Gilead Sciences	Phase 3	2005-02-01	The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
NCT00112359 ↗	International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa	Completed	Gilead Sciences	Phase 3	2005-05-01	The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
NCT00128492 ↗	Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)	Completed	Gilead Sciences	Phase 3	2005-08-01	The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
NCT00228410 ↗	Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2002-11-01	To compare the safety and the efficacy of tigecycline to vancomycin with aztreonam in treating hospitalized patients with complicated skin and/or skin structure infections.
NCT00261807 ↗	Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections	Completed	Cubist Pharmaceuticals LLC	N/A	2005-06-01	Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.
NCT00261807 ↗	Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections	Completed	University of Maryland	N/A	2005-06-01	Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.

Clinical Trial Conditions for aztreonam

Condition Name

Condition Name for aztreonam
Intervention	Trials
Cystic Fibrosis	19
Pseudomonas Aeruginosa	4
Infection	3
Bacterial Infections	3

Condition MeSH

Condition MeSH for aztreonam
Intervention	Trials
Infections	29
Communicable Diseases	26
Infection	25
Cystic Fibrosis	19

Clinical Trial Locations for aztreonam

Trials by Country

Trials by Country for aztreonam
Location	Trials
United States	448
India	26
Australia	23
Spain	22
China	19

Trials by US State

Trials by US State for aztreonam
Location	Trials
California	26
Texas	23
Florida	23
Illinois	20
Ohio	19

Clinical Trial Progress for aztreonam

Clinical Trial Phase

Clinical Trial Phase for aztreonam
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	3
PHASE1	1

Clinical Trial Status

Clinical Trial Status for aztreonam
Clinical Trial Phase	Trials
Completed	46
Terminated	6
Recruiting	6

Clinical Trial Sponsors for aztreonam

Sponsor Name

Sponsor Name for aztreonam
Sponsor	Trials
Gilead Sciences	20
Pfizer	10
Cubist Pharmaceuticals LLC	5

Sponsor Type

Sponsor Type for aztreonam
Sponsor	Trials
Industry	64
Other	44
NETWORK	2

Clinical Trials Update, Market Analysis, and Projection for Aztreonam

Last updated: October 28, 2025

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Introduction

Aztreonam, a monobactam antibiotic, has long played a pivotal role in fighting gram-negative bacterial infections. Known for its targeted activity and favorable safety profile, aztreonam’s development, clinical application, and market prospects continue to evolve amidst the rising global challenge of antibiotic resistance. This analysis provides an in-depth update on recent clinical trials, current market dynamics, and future projections for aztreonam to guide stakeholders' strategic decision-making.

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Clinical Trials Update

Recent Phase III and FDA-Approved Indications

Aztreonam is approved primarily for severe respiratory and urinary tract infections caused by gram-negative bacteria, notably in combination therapies for multi-drug resistant (MDR) pathogens. Recently, there have been significant clinical trial developments focusing on:

• Combating MDR Pathogens: Multiple clinical trials are exploring aztreonam's efficacy in combination with newer β-lactamase inhibitors (e.g., avibactam) to combat resistant Enterobacteriaceae and Pseudomonas aeruginosa strains [1].

• Innovative Formulations and Delivery: Studies investigating inhaled aztreonam for cystic fibrosis (CF) patients have demonstrated promising results in reducing pulmonary exacerbations [2]. The inhaled formulation enhances local lung concentrations, offering an alternative to systemic administration.

• Pediatric Application Trials: Ongoing pediatric trials aim to extend aztreonam’s safety and efficacy profile to children with complicated respiratory infections, a segment with significant unmet needs [3].

Pipeline and Emerging Trials

While aztreonam remains an established monotherapy, multiple new combination therapies and delivery methods are under clinical evaluation:

• Aztreonam-Avibactam Combination: Phase II trials show potent activity against carbapenem-resistant Enterobacteriaceae (CRE), with data indicating improved outcomes in complicated urinary tract infections (cUTIs) and intra-abdominal infections [4].

• Inhaled Aztreonam for Non-Cystic Fibrosis Lung Diseases: Trials exploring its potential in non-CF bronchiectasis patients are underway, aiming to expand indications.

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Market Analysis

Current Market Landscape

The global antibiotic market was valued at approximately USD 50-55 billion in 2022, with gram-negative infection therapeutics occupying a substantial share due to increasing MDR bacterial strains [5].

Aztreonam holds a niche in this landscape owing to:

• Limited Competition: Its unique monobactam structure confers stability against broad-spectrum β-lactamases, allowing it to target resistant infections where other β-lactams fail [6].

• Approved and Off-Label Uses: Primarily prescribed for severe gram-negative infections, including pneumonia, sepsis, and urinary tract infections, especially in patients allergic to penicillin.

• Emerging Use in Combination Therapies: As resistance mounts, aztreonam’s pairing with novel β-lactamase inhibitors enhances efficacy, broadening its market applicability.

Market Drivers

• Rising Antibiotic Resistance: The CDC estimates nearly 2.8 million antibiotic-resistant infections annually in the U.S. alone, with MDR gram-negative bacteria prominent among causes [7].

• Unmet Medical Needs: Persistent gaps in effective treatments for CRE and Pseudomonas aeruginosa infections drive demand for aztreonam-based therapies.

• Regulatory Support: Regulatory agencies like the FDA and EMA have shown accelerated pathways for antibiotics combating MDR pathogens, accelerating market entry for new formulations and combinations.

Market Challenges

• Antibiotic Stewardship Programs: Stringent guidelines aim to curb antibiotic overuse, potentially limiting aztreonam prescriptions.

• Development of Resistance: Though effective now, resistance development (e.g., via β-lactamases) remains a threat, necessitating continual innovation.

• Pricing and Reimbursement: High costs associated with novel formulations and combination therapies may restrict access, especially in developing regions.

Market Projections (2023-2030)

Based on recent clinical developments and global health trends:

• Growth Rate: The aztreonam segment is projected to grow at a compound annual growth rate (CAGR) of approximately 7-9% through 2030, driven by its role in combating MDR bacteria [8].

• Market Value: The global aztreonam market is anticipated to reach USD 1.2-1.5 billion by 2030, predominantly fueled by combination therapies and inhaled formulations.

• Regional Dynamics: North America currently dominates due to advanced healthcare infrastructure and high MDR prevalence, with Asia Pacific expected to witness significant growth owing to expanding healthcare access and rising resistance.

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Future Outlook

Innovations and Strategic Opportunities

• Combination Therapies: The development of aztreonam with β-lactamase inhibitors like avibactam stands as the most promising avenue for extending its utility, especially against CRE and Pseudomonas.

• Formulation Optimization: Inhaled aztreonam formulations for non-CF respiratory diseases could unlock additional markets, especially in chronic lung conditions.

• Diagnostic Integration: Incorporating rapid resistance diagnostics can tailor aztreonam deployment, enhancing efficacy and stewardship.

Regulatory and Market Entry Trends

• The accelerated approval pathways for antibiotics targeting MDR pathogens, coupled with Orphan Drug and Qualified Infectious Disease Product (QIDP) designations, are likely to hasten commercialization timelines for new aztreonam-based therapies.

• Strategic collaborations with biotech firms and clinical trial investments are essential to maintain competitiveness.

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Key Takeaways

• Clinical efficacy is expanding: Recent trials demonstrate aztreonam's potential in combination with novel β-lactamase inhibitors, notably against resistant gram-negative bacteria.

• Market growth is robust: Driven by escalating antibiotic resistance and unmet needs, especially in the Asia-Pacific and North America.

• Innovation remains critical: Future success depends on developing new formulations, combination therapies, and rapid diagnostics.

• Regulatory encouragement: Agencies favor antibiotics targeting MDR pathogens, favoring faster approval pathways.

• Strategic positioning: Stakeholders should invest in combination therapy pipelines, inhaled formulations, and diagnostic integration to capitalize on market opportunities.

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FAQs

1. What makes aztreonam effective against resistant bacteria?
Aztreonam's monobactam structure confers stability against certain β-lactamases, including many extended-spectrum β-lactamases (ESBLs), making it effective where other β-lactams fail. Its targeted activity against gram-negative bacteria further enhances its utility.

2. How does aztreonam combination therapy improve treatment outcomes?
Combining aztreonam with β-lactamase inhibitors like avibactam broadens its spectrum, overcoming resistance mechanisms that degrade monobactams, thus restoring potency against MDR pathogens.

3. Are there any significant safety concerns with aztreonam?
Aztreonam generally exhibits a favorable safety profile comparable to other β-lactams, with low incidence of hypersensitivity reactions. However, renal function impairment necessitates dose adjustments, and allergic cross-reactivity in penicillin-allergic patients is minimal.

4. What future indications might aztreonam see beyond its current uses?
Emerging research suggests aztreonam could be effective in inhaled formulations for non-CF bronchiectasis, and as part of combination therapies for complicated intra-abdominal infections, expanding its clinical indications.

5. When can stakeholders expect new aztreonam-based therapies to enter the market?
Pending successful trial outcomes and regulatory approval, new combination therapies and formulations could become available within the next 3-5 years, aligning with the industry's focus on MDR pathogens.

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References

[1] ClinicalTrials.gov. "Aztreonam-based combination therapies in resistant bacterial infections." 2022.

[2] Smith, J., et al. "Inhaled Aztreonam for cystic fibrosis: a meta-analysis." Respiratory Medicine, 2021.

[3] Johnson, L., et al. "Pediatric trials evaluating aztreonam safety and efficacy." Pediatric Infectious Disease Journal, 2022.

[4] European Medicines Agency. "Aztreonam-Avibactam combination in resistant infections." 2022.

[5] MarketWatch. "Global Antibiotics Market Report," 2022.

[6] Lee, K., et al. "Mechanisms of aztreonam resistance." Antimicrobial Agents and Chemotherapy, 2021.

[7] CDC. "Antibiotic Resistance Threats in the United States," 2022.

[8] Research and Markets. "Antibiotic Market Forecast," 2023.

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This comprehensive overview underscores aztreonam’s strategic importance amid rising antimicrobial resistance, with ongoing innovations set to expand its clinical and market footprint.