AZTREONAM
Aztreonam is a monobactam antibacterial used to manage various infections caused by susceptible Gram-negative bacteria. It helps patients with conditions ranging from urinary tract and respiratory infections to more severe cases like septicemia and intra-abdominal infections. Clinicians typically prescribe this medication when culture results or local epidemiology suggest that these specific bacteria are responsible for the illness.
How AZTREONAM Works
Aztreonam works by inhibiting the synthesis of bacterial cell walls, which leads to the death of the bacteria. As a bactericidal agent, it maintains its activity even in the presence of certain enzymes, such as penicillinases and cephalosporinases, that often break down other antibiotics.
Details
- Status
- Prescription
- First Approved
- 2010-06-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AZTREONAM Approval History
What AZTREONAM Treats
8 indicationsAZTREONAM is approved for 8 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
- Pyelonephritis
- Cystitis
- Lower Respiratory Tract Infection
- Pneumonia
- Bronchitis
- Septicemia
- Skin and Skin-Structure Infection
AZTREONAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AZTREONAM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03867734 results posted | STUDY00003878-02 | Ph 2, Ph 3 | completed | Aztreonam for Pharyngeal Gonorrhea |
| NCT02894684 AZTEC-CF | 2016AZLIND001 | Ph 4 | completed | Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis |
| NCT02276482 results posted | 1986-012 TR701-122, 2014-004023-40 | Ph 3 | completed | Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012) |
| NCT01659866 results posted | STU00059558 EAM-237 | Ph 4 | completed | Antibiotic Prophylaxis for Transrectal Prostate Biopsy |
| NCT03376529 | SPR741-102 | Ph 1 | completed | Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741 |
| NCT01984684 results posted | RX-3341-303 | Ph 3 | completed | Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections |
| NCT01811732 results posted | RX-3341-302 2012-001767-71 | Ph 3 | completed | Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections |
| NCT02202135 results posted | D3720C00001sub | Ph 3 | terminated | Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections. |
| NCT01499277 results posted | D3720C00001 2011-004013-16 | Ph 3 | completed | Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections |
| NCT00633152 results posted | P903-19 | Ph 2 | completed | Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AZTREONAM FDA Label Details
Indications & Usage
AZTREONAM is indicated for the treatment of Urinary Tract Infection; Pyelonephritis; Cystitis; Lower Respiratory Tract Infection; Pneumonia; Bronchitis; Septicemia; Skin and Skin-Structure Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.