aztreonam has been researched along with Soft Tissue Infections in 7 studies
Aztreonam: A monocyclic beta-lactam antibiotic originally isolated from Chromobacterium violaceum. It is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinfection with gram-positive organisms.
aztreonam : A synthetic monocyclic beta-lactam antibiotic (monobactam), used primarily to treat infections caused by Gram-negative bacteria. It inhibits mucopeptide synthesis in the bacterial cell wall, thereby blocking peptidoglycan crosslinking.
Soft Tissue Infections: Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)
| Excerpt | Relevance | Reference |
|---|---|---|
| " Equally important is the need to provide therapy that is safe and well tolerated." | 2.75 | Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. ( Corrado, ML, 2010) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 6 (85.71) | 24.3611 |
| 2020's | 1 (14.29) | 2.80 |
| Authors | Studies |
|---|---|
| Miller, J | 1 |
| Hall, B | 1 |
| Wilson, K | 1 |
| Cobian, J | 1 |
| Eckmann, C | 1 |
| Dryden, M | 1 |
| Zhang, Y | 1 |
| Wilson, D | 1 |
| Iaconis, JP | 1 |
| Gonzalez, J | 1 |
| Corey, GR | 2 |
| Wilcox, MH | 2 |
| Talbot, GH | 2 |
| Thye, D | 2 |
| Friedland, D | 2 |
| Baculik, T | 2 |
| Corrado, ML | 1 |
| Giuliano, C | 1 |
| Kale-Pradhan, PB | 1 |
| Johnson, LB | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) vs Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissu[NCT02202135] | Phase 3 | 4 participants (Actual) | Interventional | 2014-06-30 | Terminated (stopped due to "Overall study status is changed to Terminated due to low enrollment") | ||
| A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft T[NCT01499277] | Phase 3 | 802 participants (Actual) | Interventional | 2012-05-31 | Completed | ||
| A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection[NCT00424190] | Phase 3 | 698 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
| A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)[NCT00423657] | Phase 3 | 680 participants (Actual) | Interventional | 2007-03-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose. (NCT02202135)
Timeframe: 7 to 20 days after last dose of study drug
| Intervention | Participant (Number) | ||
|---|---|---|---|
| Clinical cure | Clinical failure | Indeterminate | |
| Ceftaroline | 3 | 0 | 1 |
The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC. (NCT01499277)
Timeframe: 21 to 42 days after the last dose of study drug
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Relapse | No relapse | Indeterminate | Missing | |
| Ceftaroline | 3 | 335 | 3 | 1 |
| Vancomycin/Aztreonam | 3 | 174 | 3 | 0 |
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. (NCT01499277)
Timeframe: On day of last dose of study drug (or + 1 day)
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Clinical cure | Clinical failure | Indeterminate | Missing | |
| Ceftaroline | 429 | 44 | 31 | 2 |
| Vancomycin/Aztreonam | 213 | 29 | 11 | 2 |
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. (NCT01499277)
Timeframe: On day of last dose of study drug (or +1 day)
| Intervention | Participants (Number) | |
|---|---|---|
| Clinical cure | Clinical failure | |
| Ceftaroline | 356 | 39 |
| Vancomycin/Aztreonam | 184 | 27 |
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug
| Intervention | Participant (Number) | ||
|---|---|---|---|
| Clinical cure | Clinical failure | indeterminate | |
| Ceftaroline | 396 | 58 | 52 |
| Vancomycin/Aztreonam | 202 | 34 | 19 |
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug
| Intervention | Participant (Number) | |
|---|---|---|
| Clinical cure | Clinical failure | |
| Ceftaroline | 342 | 53 |
| Vancomycin/Aztreonam | 180 | 31 |
The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline. (NCT01499277)
Timeframe: 48 to 72 hours after first dose of study drug
| Intervention | Participants (Number) | ||
|---|---|---|---|
| success | failure | Indeterminate | |
| Ceftaroline | 445 | 28 | 33 |
| Vancomycin/Aztreonam | 229 | 11 | 15 |
Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug
| Intervention | Participant (Number) | ||
|---|---|---|---|
| Favorable | Unfavorable | Indeterminate | |
| Ceftaroline | 203 | 17 | 28 |
| Vancomycin/Aztreonam | 109 | 17 | 10 |
Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug
| Intervention | Participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MSSA - Favorable; (n=94, 57) | MSSA - Unfavorable; (n=94, 57) | MRSA - Favorable; (n=25, 15) | MRSA - Unfavorable; (n=25, 15) | Streptococcus pyogenes - Favorable; (n=15, 7) | Streptococcus pyogenes - Unfavorable; (n=15, 7) | Streptococcus agalactiae - Favorable; (n=6, 9) | Streptococcus agalactiae - Unfavorable; (n=6, 9) | Streptococcus dysgalactiae - Favorable; (n=9, 0) | Streptococcus dysgalactiae - Unfavorable; (n=9, 0) | Enterococcus faecalis - Favorable; (n=6, 5) | Enterococcus faecalis - Unfavorable; (n=6, 5) | Escherichia coli - Favorable; (n=12, 10) | Escherichia coli - Unfavorable; (n=12, 10) | Klebsiella pneumoniae - Favorable; (n=7, 4) | Klebsiella pneumoniae - Unfavorable; (n=7, 4) | Klebsiella oxytoca - Favorable; (n=4, 1) | Klebsiella oxytoca - Unfavorable; (n=4, 1) | Proteus mirabilis - Favorable; (n=7, 2) | Proteus mirabilis - Unfavorable; (n=7, 2) | Morganella morganii - Favorable; (n=4, 2) | Morganella morganii - Unfavorable; (n=4, 2) | Enterobacter cloacae - Favorable; (n=4, 5) | Enterobacter cloacae - Unfavorable; (n=4, 5) | |
| Ceftaroline | 91 | 3 | 22 | 3 | 14 | 1 | 6 | 0 | 9 | 0 | 5 | 1 | 12 | 0 | 6 | 1 | 4 | 0 | 6 | 1 | 4 | 0 | 4 | 0 |
| Vancomycin/Aztreonam | 49 | 8 | 12 | 3 | 7 | 0 | 9 | 0 | 0 | 0 | 4 | 1 | 9 | 1 | 3 | 1 | 1 | 0 | 2 | 0 | 2 | 0 | 5 | 0 |
Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. (NCT01499277)
Timeframe: 7 to 20 days after the last dose of study drug
| Intervention | Participant (Number) | |
|---|---|---|
| Favourable | Unfavorable | |
| Ceftaroline | 167 | 14 |
| Vancomycin/Aztreonam | 98 | 14 |
"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.~Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.~Indeterminate: Inability to determine an outcome" (NCT00424190)
Timeframe: 8-15 days after the end of treatment
| Intervention | participants (Number) | ||
|---|---|---|---|
| Clinical Cure | Clinical Failure | Indeterminate | |
| Ceftaroline Fosamil for Injection | 304 | 29 | 18 |
| IV Vancomycin Plus IV Aztreonam | 297 | 21 | 29 |
"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.~Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.~Indeterminate: Inability to determine an outcome" (NCT00423657)
Timeframe: 8-15 days after last dose of study drug administration
| Intervention | participants (Number) | ||
|---|---|---|---|
| Clinical Cure | Clinical Failure | Indeterminate | |
| Ceftaroline for Injection | 291 | 25 | 26 |
| IV Vancomycin Plus IV Aztreonam | 289 | 28 | 21 |
4 trials available for aztreonam and Soft Tissue Infections
3 other studies available for aztreonam and Soft Tissue Infections
| Article | Year |
|---|---|
Impact of SEP-1 on broad-spectrum combination antibiotic therapy in the emergency department.
Topics: Adult; Aged; Anti-Bacterial Agents; Aztreonam; beta-Lactams; Cefepime; Centers for Medicare and Medi | 2020 |
[Efficacy of ceftaroline in treating complicated skin and soft tissue infections].
Topics: Aztreonam; Ceftaroline; Cephalosporins; Drug Therapy, Combination; Humans; Randomized Controlled Tri | 2014 |
Early response of ceftaroline fosamic in the treatment of soft-tissue infections.
Topics: Anti-Bacterial Agents; Aztreonam; Ceftaroline; Cephalosporins; Community-Acquired Infections; Endpoi | 2012 |