ArticleAntimicrobial agents and chemotherapy2016
Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients.
Article in Antimicrobial agents and chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01893346 (A Phase I Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ceftazidime-Avibactam), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 I Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ceftazidime-Avibactam (CAZ-AVI) in Children From 3 Months of Age to <18 Years Who Are Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Infection
Who cites it
30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 59 citations in OpenAlex.
- Efficacy of Ceftazidime-avibactam in treating Gram-negative infections: a systematic review and meta-analysis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025Pooled it
- Pharmacological aspects and spectrum of action of ceftazidime-avibactam: a systematic review.Infection · 2018Pooled it
- Population Pharmacokinetic Modeling and Probability of Pharmacodynamic Target Attainment for Ceftazidime-Avibactam in Pediatric Patients Aged 3 Months and Older.Clinical pharmacology and therapeutics · 2022Trial
- Population Pharmacokinetics and Dosing Optimization of Ceftazidime in Infants.Antimicrobial agents and chemotherapy · 2018Trial
- Reserve antibiotics in paediatrics: single-centre clinical experience and antimicrobial stewardship implementation.European journal of pediatrics · 2026Observational
- Stewardship Challenges, PK/PD Evidence, and Prescribing Appropriateness for Recently Approved Antibiotics in Pediatric Practice.Antibiotics (Basel, Switzerland) · 2026Review
- Antimicrobial Resistance in Pediatric Infections: Current Status, Challenges, and Future Directions.Antibiotics (Basel, Switzerland) · 2026Review
- Ceftazidime-avibactam for multidrug and pandrug-resistant gram-negative infections in critically Ill children: a single-center pediatric ıntensive care experience.European journal of pediatrics · 2026Observational
- Do the redefined EUCAST susceptibility categories warrant adjustment of paediatric antibiotic dosages? Pragmatic physiologically based pharmacokinetic modelling of four commonly used agents.The Journal of antimicrobial chemotherapy · 2026Article
- Drug-resistant gram-negative bacterial infections in children in the Oceania region: review of the epidemiology, antimicrobial availability, treatment, clinical trial and pharmacokinetic data, and key evidence gaps.The Lancet regional health. Western Pacific · 2025Review
- Ceftazidime/Avibactam for the Treatment of Infections in Children: A Case Series of Real-World Use.Paediatric drugs · 2025Review
- Multi-Drug Resistant Gram-Negative Sepsis in Neonates: The Special Role of Ceftazidime/Avibactam and Ceftolozane/Tazobactam.Medicines (Basel, Switzerland) · 2025Review
- Clinical efficacy, safety and pharmacokinetics of novel β-lactam/β-lactamase inhibitor combinations: a systematic review.JAC-antimicrobial resistance · 2025Review
- Ceftazidime-Avibactam as a Salvage Treatment for Severely Infected Immunosuppressed Children.Drug design, development and therapy · 2024Article
- Novel Beta Lactam Antibiotics for the Treatment of Multidrug-Resistant Gram-Negative Infections in Children: A Narrative Review.Microorganisms · 2023Review
- Use of Newer and Repurposed Antibiotics against Gram-Negative Bacteria in Neonates.Antibiotics (Basel, Switzerland) · 2023Review
- New Antimicrobials for the Treatment of Neonatal Sepsis Caused by Multi-Drug-Resistant Bacteria: A Systematic Review.Antibiotics (Basel, Switzerland) · 2023Review
- Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022Review
- Intravenous Ceftazidime-Avibactam in Extremely Premature Neonates With Carbapenem-Resistant Enterobacteriaceae: Two Case Reports.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Carbapenem-Resistant Gram-Negative Bacterial Infections in Children.Antimicrobial agents and chemotherapy · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 11 institutions in 2 countries.
Funding
Abstract
This study aimed to investigate the pharmacokinetics (PK), safety, and tolerability of a single dose of ceftazidime-avibactam in pediatric patients. A phase I, multicenter, open-label PK study was conducted in pediatric patients hospitalized with an infection and receiving systemic antibiotic therapy. Patients were enrolled into four age cohorts (cohort 1, ≥12 to <18 years; cohort 2, ≥6 to <12 years; cohort 3, ≥2 to <6 years; cohort 4, ≥3 months to <2 years). Patients received a single 2-h intravenous infusion of ceftazidime-avibactam (cohort 1, 2,000 to 500 mg; cohort 2, 2,000 to 500 mg [≥40 kg] or 50 to 12.5 mg/kg [<40 kg]; cohorts 3 and 4, 50 to 12.5 mg/kg). Blood samples were collected to describe individual PK characteristics for ceftazidime and avibactam. Population PK modeling was used to describe characteristics of ceftazidime and avibactam PK across all age groups. Safety and tolerability were assessed. Thirty-two patients received study drug. Mean plasma concentration-time curves, geometric mean maximum concentration (Cmax), and area under the concentration-time curve from time zero to infinity (AUC0-∞) were similar across all cohorts for both drugs. Six patients (18.8%) reported an adverse event, all mild or moderate in intensity. No deaths or serious adverse events occurred. The single-dose PK of ceftazidime and avibactam were comparable between each of the 4 age cohorts investigated and were broadly similar to those previously observed in adults. No new safety concerns were identified. (This study has been registered at ClinicalTrials.gov under registration no. NCT01893346.).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.