Page last updated: 2024-10-23

aztreonam and Systemic Inflammatory Response Syndrome

aztreonam has been researched along with Systemic Inflammatory Response Syndrome in 1 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.

Systemic Inflammatory Response Syndrome: A systemic inflammatory response to a variety of clinical insults, characterized by two or more of the following conditions: (1) fever

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's1 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Dryden, M1
Zhang, Y1
Wilson, D1
Iaconis, JP1
Gonzalez, J1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 34 participants (Actual)Interventional2014-06-30Terminated (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 3802 participants (Actual)Interventional2012-05-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Clinical Response at TOC

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

InterventionParticipant (Number)
Clinical cureClinical failureIndeterminate
Ceftaroline301

Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC

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

,
InterventionParticipants (Number)
RelapseNo relapseIndeterminateMissing
Ceftaroline333531
Vancomycin/Aztreonam317430

Clinical Response at End of Treatment (EOT) in MITT Analysis Set

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)

,
InterventionParticipants (Number)
Clinical cureClinical failureIndeterminateMissing
Ceftaroline42944312
Vancomycin/Aztreonam21329112

Clinical Response at EOT in CE Analysis Set

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)

,
InterventionParticipants (Number)
Clinical cureClinical failure
Ceftaroline35639
Vancomycin/Aztreonam18427

Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set

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

,
InterventionParticipant (Number)
Clinical cureClinical failureindeterminate
Ceftaroline3965852
Vancomycin/Aztreonam2023419

Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set

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

,
InterventionParticipant (Number)
Clinical cureClinical failure
Ceftaroline34253
Vancomycin/Aztreonam18031

Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set

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

,
InterventionParticipants (Number)
successfailureIndeterminate
Ceftaroline4452833
Vancomycin/Aztreonam2291115

Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set

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

,
InterventionParticipant (Number)
FavorableUnfavorableIndeterminate
Ceftaroline2031728
Vancomycin/Aztreonam1091710

Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME

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

,
InterventionParticipants (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)
Ceftaroline9132231416090511206140614040
Vancomycin/Aztreonam49812370900041913110202050

Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set

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

,
InterventionParticipant (Number)
FavourableUnfavorable
Ceftaroline16714
Vancomycin/Aztreonam9814

Trials

1 trial available for aztreonam and Systemic Inflammatory Response Syndrome

ArticleYear
A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities
    The Journal of antimicrobial chemotherapy, 2016, Volume: 71, Issue:12

    Topics: Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Aztr

2016
A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities
    The Journal of antimicrobial chemotherapy, 2016, Volume: 71, Issue:12

    Topics: Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Aztr

2016
A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities
    The Journal of antimicrobial chemotherapy, 2016, Volume: 71, Issue:12

    Topics: Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Aztr

2016
A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities
    The Journal of antimicrobial chemotherapy, 2016, Volume: 71, Issue:12

    Topics: Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Aztr

2016