Evidence map›Paper›PMID 16236177›Full record

Trial reportBMC infectious diseases2005

A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID Numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744].

María E Oliva, Arcot Rekha, Albert Yellin, Jacyr Pasternak, Maria Campos, Gilbert M Rose, Timothy Babinchak, Evelyn J Ellis-Grosse, Evan Loh, 301 Study Group

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in BMC infectious diseases, 2005. 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 47 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 9 pooled it
10.3field-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.

NCT00081744 phase3completednot on this map

A Multicenter, Double-Blind, Randomized Comparison Study Of the Efficacy and Safety of Tigecycline to Imipenem/ Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects

TypeinterventionalSponsorWyeth is now a wholly owned subsidiary of PfizerRan2002 to 2004Enrolled850ConditionsGram-Positive Bacterial Infections, Cross InfectionArmsTigecycline
NCT03973775 phase3completednot on this mapstarted 2018, after this paper: background citation

A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group, Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies

TypeinterventionalSponsorSaptalis Pharmaceuticals LLCRan2018 to 2018Enrolled126ConditionsScabiesArmsPermethrin Cream 5%
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 9 syntheses or guidelines pooled it, 153 citations in OpenAlex.

  1. Pooled it
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  4. 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
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  7. 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
  8. Pooled it
  9. Pooled it
  10. Trial
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  15. Review
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  18. Radiosynthesis and Preclinical Evaluation of [Pharmaceuticals (Basel, Switzerland) · 2024
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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

10 authors at 5 institutions in 5 countries.

María E OlivaHospital San Martin, Provincia de Entre Rios, Argentina. mariaeugeniaoliva@yahoo.com.ar
Arcot Rekha
Albert Yellin
Jacyr Pasternak
Maria Campos
Gilbert M Rose
Timothy Babinchak
Evelyn J Ellis-Grosse
Evan Loh
301 Study Group
Women's Health Research Institute · CABeneficência Portuguesa de São Paulo · BRHospital Dipreca · CLLAC+USC Medical Center · USSri Ramachandra Institute of Higher Education and Research · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundComplicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. The efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI.

methodsA prospective, double-blind, multinational trial was conducted in which patients with cIAI randomly received intravenous (IV) tigecycline (100 mg initial dose, then 50 mg every 12 hours [q12h]) or IV IMI/CIS (500/500 mg q6h or adjusted for renal dysfunction) for 5 to14 days. Clinical response at the test-of-cure (TOC) visit (14-35 days after therapy) for microbiologically evaluable (ME) and microbiological modified intent-to-treat (m-mITT) populations were the co-primary efficacy endpoint populations.

resultsA total of 825 patients received >or= 1 dose of study drug. The primary diagnoses for the ME group were complicated appendicitis (59%), and intestinal (8.8%) and gastric/duodenal perforations (4.6%). For the ME group, clinical cure rates at TOC were 80.6% (199/247) for tigecycline versus 82.4% (210/255) for IMI/CIS (95% CI -8.4, 5.1 for non-inferiority tigecycline versus IMI/CIS). Corresponding clinical cure rates within the m-mITT population were 73.5% (227/309) for tigecycline versus 78.2% (244/312) for IMI/CIS (95% CI -11.0, 2.5). Nausea (31.0% tigecycline, 24.8% IMI/CIS [P = 0.052]), vomiting (25.7% tigecycline, 19.4% IMI/CIS [P = 0.037]), and diarrhea (21.3% tigecycline, 18.9% IMI/CIS [P = 0.435]) were the most frequently reported adverse events.

conclusionThis study demonstrates that tigecycline is as efficacious as imipenem/cilastatin in the treatment of patients with cIAI.

Indexed as

AbdomenAdultAnti-Bacterial AgentsAppendicitisBacterial InfectionsCholecystitisCilastatinCilastatin, Imipenem Drug CombinationDiverticulitisDouble-Blind MethodDrug CombinationsFemaleHumansImipenemIntestinal PerforationMaleAnti-Bacterial AgentsCilastatinCilastatin, Imipenem Drug CombinationDrug CombinationsImipenemMinocyclineTigecycline

Identifiers

PMID16236177
PMCPMC1277826
OpenAlexW1522563507

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.