Evidence map›Paper›PMID 19740418›Full record

Trial reportBMC pulmonary medicine2009

Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia.

Cristina Tanaseanu, Slobodan Milutinovic, Petre I Calistru, Janos Strausz, Marius Zolubas, Valeriy Chernyak, Nathalie Dartois, Nathalie Castaing, Hassan Gandjini, C Angel Cooper and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pulmonary medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00081575 (A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Intravenous Tigecycline Vs Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia), which is not on this map. Cited by 22 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 5 pooled it
4.6field-weighted citation impact, top 5% 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.

NCT00081575 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Intravenous Tigecycline Vs Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia

TypeinterventionalSponsorWyeth is now a wholly owned subsidiary of PfizerRan2004 to 2005Enrolled434ConditionsCommunity-Acquired Infections, Bacterial Pneumonia, Cross InfectionArmsTigecycline, Levofloxacin
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Busting the Myth of "Static vs Cidal": A Systemic Literature Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Pooled it
  2. Assessment of bias in outcomes reported in trials on pneumonia: a systematic review.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2014
    Pooled it
  3. Excess deaths associated with tigecycline after approval based on noninferiority trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012
    Pooled it
  4. Guidelines for the management of adult lower respiratory tract infections--full version.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2011
    Guideline
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Tigecycline and Hypoglycemia, When and How?The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2024
    Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Efficacy of intravenous tigecycline in patients withInfection and drug resistance · 2017
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. A new paradigm for clinical trials in antibiotherapy?The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2011
    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

11 authors at 5 institutions in 4 countries.

Cristina TanaseanuSt Pantelimon Clinical Emergency Hospital, Bucharest, Romania. cristina.tanaseanu@gmail.com
Slobodan Milutinovic
Petre I Calistru
Janos Strausz
Marius Zolubas
Valeriy Chernyak
Nathalie Dartois
Nathalie Castaing
Hassan Gandjini
C Angel Cooper
313 Study Group
Institut Français du Textile et de l'Habillement · FRCherkasy State Technological University · UAClinical Emergency Hospital Bucharest · ROSpitalul Clinic Dr. Victor Babes · RORepublic Klaipeda Hospital · LT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTigecycline, an expanded broad-spectrum glycylcycline, exhibits in vitro activity against many common pathogens associated with community-acquired pneumonia (CAP), as well as penetration into lung tissues that suggests effectiveness in hospitalized CAP patients. The aim of the present study was to compare the efficacy and safety of intravenous (IV) tigecycline with IV levofloxacin in hospitalized adults with CAP.

methodsIn this prospective, double-blind, non-inferiority phase 3 trial, eligible patients with a clinical diagnosis of CAP supported by radiographic evidence were stratified by Fine Pneumonia Severity Index and randomized to tigecycline or levofloxacin for 7-14 days of therapy. Co-primary efficacy endpoints were clinical response in the clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure (Day 10-21 post-therapy).

resultsOf the 428 patients who received at least one dose of study drug, 79% had CAP of mild-moderate severity according to their Fine score. Clinical cure rates for the CE population were 88.9% for tigecycline and 85.3% for levofloxacin. Corresponding c-mITT population rates were 83.7% and 81.5%, respectively. Eradication rates for Streptococcus pneumoniae were 92% for tigecycline and 89% for levofloxacin. Nausea, vomiting, and diarrhoea were the most frequently reported adverse events. Rates of premature discontinuation of study drug or study withdrawal because of any adverse event were similar for both study drugs.

conclusionThese findings suggest that IV tigecycline is non-inferior to IV levofloxacin and is generally well-tolerated in the treatment of hospitalized adults with CAP.

trial registrationNCT00081575.

Indexed as

LevofloxacinAdolescentAdultAgedAnti-Bacterial AgentsCommunity-Acquired InfectionsDiarrheaDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInfusions, IntravenousMaleMiddle AgedMinocyclineNauseaAnti-Bacterial AgentsLevofloxacinMinocyclineOfloxacinTigecycline

Identifiers

PMID19740418
PMCPMC2753558
OpenAlexW2154159203

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.