Evidence map›Paper›PMID 34374952›Full record

ArticleInfectious diseases and therapy2021

Clinical and Microbiological Outcomes of Ceftazidime-Avibactam Treatment in Adults with Gram-Negative Bacteremia: A Subset Analysis from the Phase 3 Clinical Trial Program.

John E Mazuski, Florian Wagenlehner, Antoni Torres, Yehuda Carmeli, Joseph W Chow, Dalia Wajsbrot, Gregory G Stone, Paurus Irani, David Bharucha, Karen Cheng and 1 more

6 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.4field-weighted citation impact, top 19% 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.

NCT01499290 phase3completednot on this map

A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

TypeinterventionalSponsorPfizerRan2012 to 2014Enrolled493ConditionsComplicated Intra-Abdominal InfectionArmsCAZ-AVI, Metronidazole, Meropenem
NCT01595438 phase3completednot on this map

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

TypeinterventionalSponsorPfizerRan2012 to 2014Enrolled598ConditionsComplicated Urinary Tract Infection (cUTI) Including Acute PyelonephritisArmsCeftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral), or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
NCT01599806 phase3completednot on this map

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

TypeinterventionalSponsorPfizerRan2012 to 2014Enrolled641ConditionsComplicated Urinary Tract Infection (cUTI) Including Acute PyelonephritisArmsCeftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral), or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
NCT01644643 phase3completednot on this map

An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

TypeinterventionalSponsorPfizerRan2013 to 2014Enrolled345ConditionsComplicated Urinary Tract Infection, Complicated Intra-abdominal InfectionArmsCeftazidime - Avibactam ( CAZ-AVI), Best Available Therapy, Metronidazole
NCT01726023 phase3completednot on this map

A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

TypeinterventionalSponsorPfizerRan2013 to 2015Enrolled486ConditionsComplicated Intra-abdominal InfectionArmsCeftazidime-avibactam, metronidazole, Meropenem
NCT01808092 phase3completednot on this map

A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

TypeinterventionalSponsorPfizerRan2013 to 2016Enrolled969ConditionsNosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP)Armsceftazidim-avibactam (CAZ-AVI, experimental product), meropenem (active comparator)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Resistance inAntibiotics (Basel, Switzerland) · 2023
    Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Reviewing novel treatment options for carbapenem-resistantExpert review of anti-infective therapy
    Review
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

11 authors at 7 institutions in 5 countries.

John E MazuskiDepartment of Surgery, Washington University School of Medicine, St Louis, MO, USA.
Florian WagenlehnerDepartment of Urology, Pediatric Urology and Andrology, Justus-Liebig-University, Giessen, Germany.ORCID https://orcid.org/0000-0002-2909-0797
Antoni TorresDepartment of Pulmonology, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERES, ICREA, Barcelona, Spain.ORCID https://orcid.org/0000-0002-5649-7699
Yehuda CarmeliDivision of Epidemiology, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Joseph W ChowGlobal Product Development, Pfizer, Collegeville, PA, USA.
Dalia WajsbrotBiostatistics, Pfizer, New York, NY, USA.
Gregory G StoneMicrobiology, Internal Medicine, Pfizer, Groton, CT, USA.
Paurus IraniGlobal Medical Affairs, Pfizer, Tadworth, Surrey, UK.
David BharuchaClinical Development, AbbVie, Madison, NJ, USA.
Karen ChengSafety Surveillance and Risk Management, Pfizer, Sandwich, Kent, UK.ORCID https://orcid.org/0000-0002-4004-4847
Margaret TawadrousGlobal Product Development, Pfizer, Inc, 445 Eastern Point Road, Groton, CT, 06340, USA. Margaret.Tawadrous@pfizer.com.ORCID http://orcid.org/0000-0002-6815-2647
Pfizer (United States) · USPfizer (United Kingdom) · GBAbbVie (United States) · USConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESJustus-Liebig-Universität Gießen · DETel Aviv Sourasky Medical Center · ILWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis exploratory analysis assessed efficacy and safety outcomes in patients with Gram-negative bacteremia treated with ceftazidime-avibactam or comparator across five phase 3, randomized, controlled, multi-center trials in adults with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI)/pyelonephritis, hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP).

methodsIn each trial, RECLAIM and RECLAIM 3 (cIAI; NCT01499290/NCT01726023), REPRISE (cIAI/cUTI; NCT01644643), RECAPTURE (cUTI; NCT01595438/NCT01599806), and REPROVE (HAP/VAP; NCT01808092), patients were randomized 1:1 to intravenous ceftazidime-avibactam (plus metronidazole for those with cIAI) or comparators (carbapenems in > 97% patients) for 5-21 days. Efficacy assessments included clinical and microbiological responses at the test-of-cure visit in the pooled Gram-negative extended microbiologically evaluable (GNeME) population (bacteremia subset). Safety outcomes were summarized for patients with positive bacterial blood culture(s) at baseline who received ≥ 1 dose of study treatment.

resultsThe overall safety population included 4050 patients (ceftazidime-avibactam, n = 2024; comparator, n = 2026). The GNeME population (bacteremia subset) comprised 101 patients (ceftazidime-avibactam, n = 54; comparator, n = 47). Clinical cure rates (all indications combined) were 47/54 (87.0%) for ceftazidime-avibactam and 39/47 (83.0%) for comparators; favorable microbiological response rates were 43/54 (79.6%) and 32/47 (68.1%), respectively. Clinical and microbiological responses in the bacteremia subset were generally similar to those in the overall set. The pattern of adverse events in patients with bacteremia was similar between treatment groups and was consistent with the known safety profile of ceftazidime-avibactam.

conclusionThis analysis provides supportive evidence of the efficacy and safety of ceftazidime-avibactam in patients with Gram-negative bacteremia associated with cIAI, cUTI/pyelonephritis, or HAP/VAP.

Indexed as

BacteremiaCeftazidime-avibactamComplicated intra-abdominal infectionComplicated urinary tract infectionEfficacyHospital-acquired pneumonia

Identifiers

PMID34374952
PMCPMC8353612
OpenAlexW3192067479

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.