Trial reportThe Journal of antimicrobial chemotherapy2020
Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study.
Trial report in The Journal of antimicrobial chemotherapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02655419 (A PHASE IIA PROSPECTIVE, OPEN-LABEL, MULTICENTER STUDY TO DETERMINE THE PHARMACOKINETICS), which is not on this map. Cited by 71 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase iia prospective, open-label, multicenter study to determine the pharmacokinetics (pk) and safety and tolerability of aztreonam-avibactam (atm-avi) for the treatment of complicated intra-abdominal infections (ciais) in hospitalized adults
Who cites it
71 citing papers in PubMed.
- Population pharmacokinetic/pharmacodynamic modeling to optimize aztreonam-avibactam dose regimens for adult patients.Antimicrobial agents and chemotherapy · 2025Trial
- Dose selection for aztreonam-avibactam, including adjustments for renal impairment, for Phase IIa and Phase III evaluation.European journal of clinical pharmacology · 2024Trial
- Trial
- The global epidemiology and treatment of metallo-β-lactamase-producing gram-negative pathogens.JAC-antimicrobial resistance · 2026Review
- Article
- Aztreonam-avibactam at the frontline: A dual-agent approach to metallo-β-lactamase resistance.The Journal of antibiotics · 2026Review
- Dosing Regimen Optimization of Aztreonam/Avibactam According to Renal Function Stratification: A Population Pharmacokinetic-Guided Simulation Study.Antibiotics (Basel, Switzerland) · 2026Article
- In vitro activity of aztreonam/avibactam and comparators against Enterobacterales isolates from patients with hospital-acquired pneumonia, ventilator-associated pneumonia, and complicated intra-abdominal infections (ATLAS, 2021-2022).The Journal of antimicrobial chemotherapy · 2026Article
- Ceftazidime/avibactam and aztreonam combined with an aminoglycoside combat metallo-β-lactamase-producingAntimicrobial agents and chemotherapy · 2026Article
- Antibiotic hybrids: A promising strategy to replenish the pipeline and combat antimicrobial resistance.Journal of microbiology (Seoul, Korea) · 2026Review
- Pharmacokinetics of Aztreonam-Avibactam After Single- and Multiple-Dose Administration: A Phase 1, Open-Label Study in Healthy Chinese Participants and Ethnic Comparison with Non-Chinese Participants.Clinical pharmacology in drug development · 2026Article
- Microbiological, Clinical, and Pharmacokinetic/Pharmacodynamic Data to Support EUCAST Aztreonam-Avibactam Minimum Inhibitory Concentration Susceptibility Breakpoints Against Enterobacterales.Infectious diseases and therapy · 2026Article
- Synergistic activity of ceftazidime/avibactam combined with aztreonam against MBL-producingFrontiers in cellular and infection microbiology · 2026Article
- Current progress in antibacterial agents for carbapenem-resistant enterobacterales.Frontiers in pharmacology · 2026Review
- Review
- Management of an infection from NDM-1-producingASM case reports · 2026Article
- β-Lactam/β-Lactamase Inhibitor Combinations in Sepsis-Associated Acute Kidney Injury and Renal Replacement Therapy.Antibiotics (Basel, Switzerland) · 2025Review
- Aztreonam-avibactam for the treatment of serious infections caused by metallo-β-lactamase-producing Gram-negative pathogens: a Phase 3 randomized trial (ASSEMBLE).JAC-antimicrobial resistance · 2025Article
- Review
- Clinical efficacy, safety and pharmacokinetics of novel β-lactam/β-lactamase inhibitor combinations: a systematic review.JAC-antimicrobial resistance · 2025Review
11 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo investigate pharmacokinetics (PK) and safety (primary objectives) and efficacy (secondary objective) of the investigational monobactam/β-lactamase inhibitor combination aztreonam/avibactam in patients with complicated intra-abdominal infection (cIAI).
methodsThis Phase 2a open-label, multicentre study (NCT02655419; EudraCT 2015-002726-39) enrolled adults with cIAI into sequential cohorts for 5-14 days treatment. Cohort 1 patients received an aztreonam/avibactam loading dose of 500/137 mg (30 min infusion), followed by maintenance doses of 1500/410 mg (3 h infusions) q6h; Cohort 2 received 500/167 mg (30 min infusion), followed by 1500/500 mg (3 h infusions) q6h. Cohort 3 was an extension of exposure at the higher dose regimen. Doses were adjusted for creatinine clearance of 31-50 mL/min (Cohorts 2 + 3). All patients received IV metronidazole 500 mg q8h. PK, safety and efficacy were assessed.
resultsThirty-four patients (Cohort 1, n = 16; Cohorts 2 + 3, n = 18) comprised the modified ITT (MITT) population. Mean exposures of aztreonam and avibactam in Cohorts 2 + 3 were consistent with those predicted to achieve joint PK/pharmacodynamic target attainment in >90% patients. Adverse events (AEs) were similar between cohorts. The most common AEs were hepatic enzyme increases [n = 9 (26.5%)] and diarrhoea [n = 5 (14.7%)]. Clinical cure rates at the test-of-cure visit overall were 20/34 (58.8%) (MITT) and 14/23 (60.9%) (microbiological-MITT population).
conclusionsObserved AEs were consistent with the known safety profile of aztreonam monotherapy, with no new safety concerns identified. These data support selection of the aztreonam/avibactam 500/167 mg (30 min infusion) loading dose and 1500/500 mg (3 h infusions) maintenance dose q6h regimen, in patients with creatinine clearance >50 mL/min, for the Phase 3 development programme.
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