Evidence map›Paper›PMID 27550351›Full record

Trial reportAntimicrobial agents and chemotherapy2016

Population Pharmacokinetics and Safety of Ceftolozane-Tazobactam in Adult Cystic Fibrosis Patients Admitted with Acute Pulmonary Exacerbation.

Marguerite L Monogue, Rebecca S Pettit, Marianne Muhlebach, Jeffrey J Cies, David P Nicolau, Joseph L Kuti

2 registry-linked trialsOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report 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 2 registered trials, which are not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
6.4field-weighted citation impact, top 4% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02421120 phase4completednot on this map

A Prospective, Multicenter, Open-Label Study to Assess Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients Admitted With Acute Pulmonary Exacerbation

TypeinterventionalSponsorJoseph L. Kuti, PharmDRan2015 to 2016Enrolled21ConditionsCystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation, Pseudomonas Aeruginosa InfectionArmsCeftolozane/Tazobactam
NCT03581370 phase3recruitingnot on this mapstarted 2018, after this paper: background citation

Comparison of Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients with Ventilator Associated-pneumonia to Pseudomonas Aeruginosa in Intensive Care Units

TypeinterventionalSponsorUniversity Hospital, ToulouseRan2018 to 2025Enrolled80ConditionsVentilator-associated PneumoniaArms1 hour infusion, 4 hours infusion
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Therapeutic Interventions forJournal of clinical medicine · 2024
    Review
  11. Article
  12. Article
  13. Pharmaceutics · 2021
    Article
  14. Ceftolozane/tazobactam for Pseudomonas aeruginosa pulmonary exacerbations in cystic fibrosis adult patients: a case series.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021
    Article
  15. Review
  16. Article
  17. Spotlight on New Antibiotics for the Treatment of Pneumonia.Clinical medicine insights. Circulatory, respiratory and pulmonary medicine · 2020
    Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Marguerite L MonogueCenter for Anti-Infective Research & Development, Hartford Hospital, Hartford, Connecticut, USA.
Rebecca S PettitRiley Hospital for Children, Indianapolis, Indiana, USA.
Marianne MuhlebachUniversity of North Carolina, Chapel Hill, North Carolina, USA.
Jeffrey J CiesSt. Christopher's Hospital for Children, Philadelphia, Pennsylvania, USA.
David P NicolauCenter for Anti-Infective Research & Development, Hartford Hospital, Hartford, Connecticut, USA.
Joseph L KutiCenter for Anti-Infective Research & Development, Hartford Hospital, Hartford, Connecticut, USA joseph.kuti@hhchealth.org.
Hartford Financial Services (United States)Hartford Hospital · USRiley Hospital for Children · USSt. Christopher's Hospital for Children · USUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ceftolozane-tazobactam has potent activity against Pseudomonas aeruginosa, a pathogen associated with cystic fibrosis (CF) acute pulmonary exacerbations (APE). Due to the rapid elimination of many antibiotics, CF patients frequently have altered pharmacokinetics. In this multicenter, open-label study, we described the population pharmacokinetics and safety of ceftolozane-tazobactam at 3 g every 8 h (q8h) in 20 adult CF patients admitted with APE. Population pharmacokinetics were determined using the nonparametric adaptive grid program in Pmetrics for R. A 5,000-patient Monte Carlo simulation was performed to determine the probability of target attainment (PTA) for the ceftolozane component at 1.5 g and 3 g of ceftolozane-tazobactam q8h across a range of MICs using a primary threshold exposure of 60% free time above the MIC (fT>MIC). In these 20 adult CF patients, ceftolozane and tazobactam concentration data were best described by 2-compartment models, and ceftolozane clearance (CL) was significantly correlated with creatinine clearance (r = 0.71, P < 0.001). These data suggest that ceftolozane and tazobactam clearance estimates in CF patients are similar to those in adults without CF (ceftolozane CF CL, 4.76 ± 1.13 liter/h; tazobactam CF CL, 20.51 ± 4.41 liter/h). However, estimates of the volume of the central compartment (V

Indexed as

Acute DiseaseAdolescentAdultAnti-Bacterial AgentsCephalosporinsCystic FibrosisFemaleHumansInfusions, IntravenousLungMaleMethicillin-Resistant Staphylococcus aureusMicrobial Sensitivity TestsMiddle AgedMonte Carlo MethodPatient SafetyAnti-Bacterial Agentsceftolozane, tazobactam drug combinationCephalosporinsPenicillanic AcidTazobactam

Identifiers

PMID27550351
PMCPMC5075062
OpenAlexW2515632632

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.