Evidence map›Paper›PMID 16251309›Full record

Trial reportAntimicrobial agents and chemotherapy2005

Safety and efficacy of tigecycline in treatment of skin and skin structure infections: results of a double-blind phase 3 comparison study with vancomycin-aztreonam.

Johannes Breedt, Jüri Teras, Janis Gardovskis, Frans Jacobus Maritz, Tiit Vaasna, Douglas Patrick Ross, Martine Gioud-Paquet, Nathalie Dartois, Evelyn J Ellis-Grosse, Evan Loh and 1 more

Abstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 8 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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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  4. 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
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  8. Interventions for cellulitis and erysipelas.The Cochrane database of systematic reviews · 2010
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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

11 authors.

Johannes BreedtEugene Marais Hospital, Les Marais, Pretoria, Republic of South Africa. jbreedt@gpnet.net
Jüri Teras
Janis Gardovskis
Frans Jacobus Maritz
Tiit Vaasna
Douglas Patrick Ross
Martine Gioud-Paquet
Nathalie Dartois
Evelyn J Ellis-Grosse
Evan Loh
Tigecycline 305 cSSSI Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a randomized, double-blind, controlled trial, 546 patients with complicated skin and skin structure infections received tigecycline 100 mg/day (a 100-mg initial dose and then 50 mg intravenously twice daily) or the combination of vancomycin 2 g/day (1 g intravenously twice daily) and aztreonam 4 g/day (2 g intravenously twice daily) for up to 14 days. The primary end point was the clinical response in the clinical modified intent-to-treat (c-mITT) and clinically evaluable (CE) populations at the test-of-cure visit 12 to 92 days after the last dose. The microbiologic response at the test-of-cure visit was also assessed. Safety was assessed by physical examination, laboratory results, and adverse event reporting. Five hundred twenty patients were included in the c-mITT population (tigecycline group, n = 261; combination group, n = 259), and 436 were clinically evaluable (tigecycline group, n = 223; combination group, n = 213). The clinical responses in the tigecycline and the combination vancomycin and aztreonam groups were similar in the c-mITT population (84.3% versus 86.9%; difference, -2.6% [95% confidence interval, -9.0, 3.8]; P = 0.4755) and the CE population (89.7% versus 94.4%; difference, -4.7% [95% confidence interval, -10.2, 0.8]; P = 0.1015). Microbiologic eradication (documented or presumed) occurred in 84.8% of the patients receiving tigecycline and 93.2% of the patients receiving vancomycin and aztreonam (difference, -8.5 [95% confidence interval, -16.0, -1.0]; P = 0.0243). The numbers of patients reporting adverse events were similar in the two groups, with increased nausea and vomiting rates in the tigecycline group and an increased incidence of rash and increases in alanine aminotransferase and aspartate aminotransferase levels in the combination vancomycin and aztreonam group. Tigecycline was shown to be safe and effective for the treatment of complicated skin and skin structure infections.

Indexed as

AdultAgedAlanine TransaminaseAspartate AminotransferasesAztreonamDrug Therapy, CombinationFemaleHumansMaleMiddle AgedMinocyclineSkin Diseases, BacterialTigecyclineVancomycinAlanine TransaminaseAspartate AminotransferasesAztreonamMinocyclineTigecyclineVancomycin

Identifiers

PMID16251309
PMCPMC1280174

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.