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.
NCT00261807 ↗	Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections	Completed	University of Maryland, Baltimore	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
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
Florida	23
Texas	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
NIH	2

Last updated: July 28, 2026

Aztreonam clinical trials update, market analysis, and projection (2026-2035)

Aztreonam (injectable) remains a niche, hospital-led antibiotic positioned around Gram-negative coverage, including difficult resistance phenotypes. Clinical activity is concentrated in (i) additional studies that expand indications within complicated infections and (ii) formulation or delivery development intended to improve dosing practicality. Commercially, the addressable market is constrained by limited mono-product demand and strong formulary pressure from broader-spectrum agents, but aztreonam’s relevance persists where clinicians need targeted activity against susceptible Gram-negative pathogens and when beta-lactam intolerance or resistance patterns drive use.

What is aztreonam used for clinically and where is it positioned in infectious disease care?

Aztreonam is a monobactam antibiotic with activity against many Gram-negative bacteria. Clinically, it is used for infections where Gram-negative coverage is required and where cross-reactivity avoidance matters in certain beta-lactam allergy contexts.

Which infection categories drive aztreonam prescribing?

Commonly targeted use areas for aztreonam products include:

• Hospital-acquired and ventilator-associated infections with Gram-negative pathogens
• Complicated urinary tract infections and complicated intra-abdominal infections when susceptibility supports monotherapy or targeted therapy
• Bacteremia and sepsis due to susceptible Gram-negative organisms
• Adjunctive roles in multi-drug regimens depending on local antibiograms

How does aztreonam fit versus cefepime, piperacillin-tazobactam, carbapenems, and aminoglycosides?

• Aztreonam’s differentiation is narrower spectrum relative to carbapenems and piperacillin-tazobactam.
• It can be a practical alternative when broader beta-lactams are not appropriate due to allergy history or stewardship decisions.
• It faces higher resistance attrition risks in settings where extended-spectrum beta-lactamase producers are prevalent and ceftazidime-avibactam or carbapenems are favored.

What are the latest aztreonam clinical trials outcomes and what endpoints are being used?

No current, complete trial register snapshot is provided in the input. Without a verified list of active or recently completed aztreonam trials (NCT numbers, dates, endpoints, arms, results), a complete clinical-trials update cannot be produced accurately.

Which aztreonam trials are most likely to change label scope or improve uptake?

A label-impacting trial for aztreonam would typically target:

• A new or broadened infection entity (for example, additional complicated infection categories)
• Non-inferiority versus standard-of-care for clinical cure and microbiological eradication
• Pharmacokinetic/pharmacodynamic (PK/PD) evidence that supports dosing changes and reduced monitoring burden
• Safety evidence to support expanded use in special populations

Without verified trial data, the most-likely candidates cannot be identified.

What is the current market size for aztreonam and what drives demand?

Aztreonam’s market is shaped by:

• Hospital inpatient formularies and antimicrobial stewardship constraints
• Resistance patterns and the local availability of newer beta-lactam/beta-lactamase inhibitor combinations
• The intensity of use for specific Gram-negative phenotypes and susceptibility rates
• Competitive substitution by broader-spectrum agents

Market demand drivers

• Gram-negative susceptibility windows that still favor aztreonam
• Avoidance of certain beta-lactams when clinical history or institutional protocols restrict options
• Formulary preferences for “coverage-first” regimens in empiric settings

Key demand headwinds

• Broad-spectrum alternatives that outperform on empiric coverage
• Rapid adoption of beta-lactam/beta-lactamase inhibitor platforms in ESBL settings
• Narrow clinical use that reduces inventory turnover versus high-volume antibiotics

How large is the addressable market by region and hospital segment for aztreonam?

Aztreonam demand is generally concentrated in:

• Large hospital systems with established infectious disease and pharmacy stewardship teams
• Regions with high inpatient antibiotic utilization where hospital formularies actively govern IV antibiotic choice

A region-by-region quantified breakdown cannot be produced from the provided input.

What is the aztreonam revenue outlook under competitive substitution and generic pressure?

Aztreonam revenue is typically subject to:

• Price compression as generics expand availability
• Substitution by newer fixed combinations that capture ESBL-related prescribing
• Stability in targeted use cases, tempered by resistance erosion

A defensible forward revenue model requires:

• Current brand/generic share
• Pricing trends and contract dynamics
• Country-level unit volumes and seasonal or regimen-specific prescribing patterns

None of these inputs are available in the prompt.

When does aztreonam lose exclusivity, and what patent or exclusivity events control generic entry risk?

No patent or exclusivity timeline for aztreonam can be constructed from the provided input alone. A correct exclusivity map depends on Orange Book listings and patent numbers (US and other jurisdictions), as well as any Pediatric Exclusivity, 505(b)(2)/505(j) exclusivity, and settlement agreements.

What is the Orange Book status of aztreonam and which patents are listed for each dosage form?

An Orange Book status requires drug product identifiers (NDCs), listed patents (with expiration dates), and whether patents are “drug substance,” “drug product,” or method-of-use. No such listing data is included in the input.

How many aztreonam patents cover formulations, methods of use, or manufacturing processes?

Patent-counting requires:

• A complete patent family set tied to listed Orange Book patents (or equivalent regulatory databases)
• Identification of relevant claim types and jurisdictional coverage

No patent dataset is provided in the input.

Which companies are challenging aztreonam via Paragraph IV and what litigation changes market entry timing?

Paragraph IV risk and litigation timing depend on:

• Filed ANDA details, Paragraph IV certifications, and court dockets
• Settlement dates and market-entry triggers

No ANDA litigation facts are included in the prompt.

How does aztreonam compare with competitor brands and generics in the IV antibiotic market?

Aztreonam competes across multiple axes:

• Spectrum breadth versus anti-ESBL coverage (ceftazidime-avibactam, meropenem, imipenem-cilastatin, cefiderocol depending on setting)
• Tolerability and allergy-driven prescribing constraints
• Cost under hospital pharmacy procurement cycles

Without quantified competitor volumes, share, and pricing trends, a rigorous market projection cannot be produced.

What is the likely aztreonam market scenario for 2026-2035 under three pathways (steady use, share loss, and rebound)?

A projection requires baseline market size, growth drivers, and demand elasticity to substitution. Since those inputs are not provided, any multi-scenario numeric forecast would be speculative.

Key Takeaways

• Aztreonam remains clinically relevant for targeted Gram-negative infections, typically in hospital settings with stewardship-driven use.
• Commercial dynamics favor agents with broader empiric coverage and modern ESBL-oriented platforms, which can limit growth.
• A credible clinical-trials update and a defensible 2026-2035 market forecast require verified trial registers and product/patent/regulatory datasets, which are not present in the provided input.

FAQs

1. Is aztreonam active against ESBL-producing Gram-negative bacteria and how does that affect prescribing?
2. Does aztreonam have safer beta-lactam allergy cross-reactivity than other beta-lactams in clinical protocols?
3. What dosing regimens are used for aztreonam in complicated urinary tract infections and what outcomes are used to evaluate them?
4. How do hospital formulary restrictions and antimicrobial stewardship policies change IV monobactam utilization?
5. What patent and Orange Book events typically govern generic entry for older IV antibiotics like aztreonam?

References

1. No sources were provided in the prompt; no external citations can be generated without a retrievable dataset.