Evidence map›Paper›PMID 23357775›Full record

Trial reportAntimicrobial agents and chemotherapy2013

Randomized phase 2 trial to evaluate the clinical efficacy of two high-dosage tigecycline regimens versus imipenem-cilastatin for treatment of hospital-acquired pneumonia.

Julio Ramirez, Nathalie Dartois, Hassan Gandjini, Jean Li Yan, Joan Korth-Bradley, Paul C McGovern

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00707239 (A Phase 2, Multicenter, Randomized, Double-Blind, Comparative Study Of The Safety And Efficacy of 2 Doses Of Tigecycline Versus Imipenem/Cilastatin For The Treatment Of Subjects With Hospital-Acquired Pneumonia), which is not on this map. Cited by 105 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
105citing papers in PubMed, 9 pooled it
10.7field-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.

NCT00707239 phase2terminatednot on this map

A Phase 2, Multicenter, Randomized, Double-Blind, Comparative Study Of The Safety And Efficacy of 2 Doses Of Tigecycline Versus Imipenem/Cilastatin For The Treatment Of Subjects With Hospital-Acquired Pneumonia

TypeinterventionalSponsorPfizerRan2008 to 2011Enrolled108ConditionsPneumonia, BacterialArmstigecycline, imipenem/cilastatin
3 · Its place in the literature

Who cites it

105 citing papers in PubMed, 9 syntheses or guidelines pooled it, 234 citations in OpenAlex.

  1. Pooled it
  2. Population Pharmacokinetics of Tigecycline: A Systematic Review.Drug design, development and therapy · 2022
    Pooled it
  3. Pooled it
  4. Pooled it
  5. 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
  6. Antibiotics for ventilator-associated pneumonia.The Cochrane database of systematic reviews · 2016
    Pooled it
  7. Pooled it
  8. Guideline
  9. Combination antibiotic treatment versus monotherapy for multidrug-resistant, extensively drug-resistant, and pandrug-resistant Acinetobacter infections: a systematic review.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2014
    Pooled it
  10. Trial
  11. Trial
  12. Co-occurrence of blaBMC microbiology · 2026
    Article
  13. Turning the Tide Against Carbapenem-resistantOpen forum infectious diseases · 2025
    Article
  14. Static vs. cidal: it's not complex; it's simply incorrect.Antimicrobial agents and chemotherapy · 2025
    Article
  15. Article
  16. Observational
  17. Review
  18. Review
  19. Article
  20. Review

45 more citing papers are in PubMed but not listed here.

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 3 institutions in 2 countries.

Julio RamirezUniversity of Louisville, Louisville, Kentucky, USA. j.ramirez@louisville.edu
Nathalie Dartois
Hassan Gandjini
Jean Li Yan
Joan Korth-Bradley
Paul C McGovern
Pfizer (United States) · USPfizer (France) · FRUniversity of Louisville · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a previous phase 3 study, the cure rates that occurred in patients with hospital-acquired pneumonia treated with tigecycline at the approved dose were lower than those seen with patients treated with imipenem and cilastatin (imipenem/cilastatin). We hypothesized that a higher dose of tigecycline is necessary in patients with hospital-acquired pneumonia. This phase 2 study compared the safety and efficacy of two higher doses of tigecycline with imipenem/cilastatin in subjects with hospital-acquired pneumonia. Subjects with hospital-acquired pneumonia were randomized to receive one of two doses of tigecycline (150 mg followed by 75 mg every 12 h or 200 mg followed by 100 mg every 12 h) or 1 g of imipenem/cilastatin every 8 h. Empirical adjunctive therapy was administered for initial coverage of methicillin-resistant Staphylococcus aureus and Pseudomonas aeruginosa infection, depending on the randomization regimen. Clinical response, defined as cure, failure of treatment, or indeterminate outcome, was assessed 10 to 21 days after the last day of therapy. In the clinically evaluable population, clinical cure with tigecycline 100 mg (17/20, 85.0%) was numerically higher than with tigecycline 75 mg (16/23, 69.6%) and imipenem/cilastatin (18/24, 75.0%). No new safety signals with the high-dose tigecycline were identified. A numerically higher clinical response was observed with the 100-mg dose of tigecycline. This supports our hypothesis that a higher area under the concentration-time curve over 24 h in the steady state divided by the MIC (AUC/MIC ratio) may be necessary to achieve clinical cure in patients with hospital-acquired pneumonia. Further studies are necessary. (The ClinicalTrials.gov identifier for this clinical trial is NCT00707239.).

Indexed as

AdultAgedAnti-Bacterial AgentsCilastatinCilastatin, Imipenem Drug CombinationDrug CombinationsFemaleHumansImipenemMaleMiddle AgedMinocyclinePneumoniaTigecyclineAnti-Bacterial AgentsCilastatinCilastatin, Imipenem Drug CombinationDrug CombinationsImipenemMinocyclineTigecycline

Identifiers

PMID23357775
PMCPMC3623336
OpenAlexW2036173518

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.