Evidence map›Paper›PMID 27313268›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

Ceftazidime-avibactam Versus Doripenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: RECAPTURE, a Phase 3 Randomized Trial Program.

Florian M Wagenlehner, Jack D Sobel, Paul Newell, Jon Armstrong, Xiangning Huang, Gregory G Stone, Katrina Yates, Leanne B Gasink

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 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 162 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
162citing papers in PubMed, 10 pooled it
31.5field-weighted citation impact, top 1% 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.

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)
3 · Its place in the literature

Who cites it

162 citing papers in PubMed, 10 syntheses or guidelines pooled it, 342 citations in OpenAlex.

  1. 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 · 2025
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  17. Antimicrobial agents and chemotherapy · 2020
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102 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Florian M WagenlehnerJustus-Liebig-University, Giessen, Germany.
Jack D SobelDetroit Medical Center, Michigan.
Paul NewellAstraZeneca, Alderley Park, Cheshire.
Jon ArmstrongAstraZeneca, Alderley Park, Cheshire.
Xiangning HuangAstraZeneca, Cambridge, United Kingdom.
Gregory G StoneAstraZeneca, Waltham, Massachusetts.
Katrina YatesAstraZeneca, Alderley Park, Cheshire.
Leanne B GasinkAstraZeneca, Wilmington, Delaware.
AstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USDetroit Medical Center · USUniversity of Giessen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe global emergence of carbapenem-resistant Enterobacteriaceae highlights the urgent need to reduce carbapenem dependence. The phase 3 RECAPTURE program compared the efficacy and safety of ceftazidime-avibactam and doripenem in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis.

methodsHospitalized adults with suspected or microbiologically confirmed cUTI/acute pyelonephritis were randomized 1:1 to ceftazidime-avibactam 2000 mg/500 mg every 8 hours or doripenem 500 mg every 8 hours (doses adjusted for renal function), with possible oral antibiotic switch after ≥5 days (total treatment duration up to 10 days or 14 days for patients with bacteremia).

resultsOf 1033 randomized patients, 393 and 417 treated with ceftazidime-avibactam and doripenem, respectively, were eligible for the primary efficacy analyses; 19.6% had ceftazidime-nonsusceptible baseline pathogens. Noninferiority of ceftazidime-avibactam vs doripenem was demonstrated for the US Food and Drug Administration co-primary endpoints of (1) patient-reported symptomatic resolution at day 5: 276 of 393 (70.2%) vs 276 of 417 (66.2%) patients (difference, 4.0% [95% confidence interval {CI}, -2.39% to 10.42%]); and (2) combined symptomatic resolution/microbiological eradication at test of cure (TOC): 280 of 393 (71.2%) vs 269 of 417 (64.5%) patients (difference, 6.7% [95% CI, .30% to 13.12%]). Microbiological eradication at TOC (European Medicines Agency primary endpoint) occurred in 304 of 393 (77.4%) ceftazidime-avibactam vs 296 of 417 (71.0%) doripenem patients (difference, 6.4% [95% CI, .33% to 12.36%]), demonstrating superiority at the 5% significance level. Both treatments showed similar efficacy against ceftazidime-nonsusceptible pathogens. Ceftazidime-avibactam had a safety profile consistent with that of ceftazidime alone.

conclusionsCeftazidime-avibactam was highly effective for the empiric treatment of cUTI (including acute pyelonephritis), and may offer an alternative to carbapenems in this setting. CLINICAL TRIALS REGISTRATION: NCT01595438; NCT01599806.

Indexed as

AdultAgedAnti-Bacterial AgentsAzabicyclo CompoundsCarbapenemsCeftazidimeDoripenemDrug CombinationsFemaleHumansMaleMiddle AgedPyelonephritisUrinary Tract InfectionsAnti-Bacterial Agentsavibactam, ceftazidime drug combinationAzabicyclo CompoundsCarbapenemsCeftazidimeDoripenemDrug Combinationsacute pyelonephritisceftazidime-avibactamcomplicated urinary tract infection

Identifiers

PMID27313268
PMCPMC4996135
OpenAlexW2437593726

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.