SynthesisClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012
Excess deaths associated with tigecycline after approval based on noninferiority trials.
Synthesis in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 120 papers, 6 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
120 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- The efficacy and safety of eravacycline compared with current clinically common antibiotics in the treatment of adults with complicated intra-abdominal infections: A Bayesian network meta-analysis.Frontiers in medicine · 2022Pooled it
- Population Pharmacokinetics of Tigecycline: A Systematic Review.Drug design, development and therapy · 2022Pooled it
- Effectiveness and Safety of High Dose Tigecycline for the Treatment of Severe Infections: A Systematic Review and Meta-Analysis.Advances in therapy · 2020Pooled it
- Efficacy and safety of high-dose tigecycline for the treatment of infectious diseases: A meta-analysis.Medicine · 2019Pooled it
- Clinical practice guidelines for the provision of renal service in Hong Kong: Infection Control in Renal Service.Nephrology (Carlton, Vic.) · 2019Guideline
- The efficacy and safety of tigecycline for the treatment of bloodstream infections: a systematic review and meta-analysis.Annals of clinical microbiology and antimicrobials · 2017Pooled it
- Epidemiology and molecular characterization of bacteremia due to carbapenem-resistant Klebsiella pneumoniae in transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2013Trial
- Tetracyclines, a timely resurgence or doomed to fail again?Journal of medical microbiology · 2026Review
- Reply to Chirumbolo, "Antimicrobial regimens for the treatment of pan-drug-resistantAntimicrobial agents and chemotherapy · 2026Article
- Integrating machine learning and artificial intelligence in the management of Acinetobacter infections: a narrative review.Infection · 2026Review
- Beyond β-Lactams: Defining the Role of Eravacycline in Multidrug-Resistant and Metallo-β-Lactamase-Producing Infections.Antibiotics (Basel, Switzerland) · 2026Review
- In-Hospital Mortality Predictors and a Bayesian Weighted-Incidence Antibiogram in Infective Endocarditis: A Seven-Year Cohort Study from a Mexican Tertiary University Hospital.Medical sciences (Basel, Switzerland) · 2026Article
- Residual confounding and outcome definition in observational comparisons of PDR-Antimicrobial agents and chemotherapy · 2026Article
- Sulbactam-Durlobactam in the Treatment of Bloodstream Infection Due to Carbapenem-ResistantJournal of clinical medicine · 2026Review
- Antimicrobial Pharmacokinetic and Pharmacodynamic Considerations in Special Populations: A Call to Action.Open forum infectious diseases · 2026Review
- Review
- Isoniazid potentiates tigecycline to kill methicillin-resistantEmerging microbes & infections · 2025Article
- Review
- Article
- Carbapenem-resistantiScience · 2024Review
60 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
backgroundOn the basis of noninferiority trials, tigecycline received Food and Drug Administration (FDA) approval in 2005. In 2010, the FDA warned in a safety communication that tigecycline was associated with an increased risk of death.
methodsPubMed, EMBASE, Scopus, and ClinicalTrials.gov were searched using the terms "tigecycline" and "randomized controlled trial (RCT)" through April 2011. Excess deaths and noncure rates for both approved and nonapproved indications were examined using meta-analysis.
resultsTen published and 3 unpublished studies met inclusion criteria (N = 7434). No significant heterogeneity was seen for mortality (I(2 )= 0%; P = .99) or noncure rates (I(2 )= 25%; P = .19). Across randomized controlled trials, tigecycline was associated with increased mortality (risk difference [RD], 0.7%; 95% confidence interval [CI], 0.1%-1.2%; P = .01) and noncure rates (RD, 2.9%; 95% CI, 0.6%-5.2%; P = .01). Effects were not isolated to type of infection or comparator antibiotic regimen, and the impact on survival remained significant when limited to trials of approved indications (I(2 )= 0%; RD, 0.6%; P = .04). A pooled analysis of the 5 trials completed by early 2005 before tigecycline was approved would have demonstrated a similar harmful effect of tigecycline on survival (I(2 )= 0%; RD, 0.7%; P = .06).
conclusionsPooling noninferiority studies to examine survival may help ensure the safety and efficacy of new antibiotics. The association of tigecycline with excess deaths and noncure includes indications for which it is approved and marketed. Tigecycline cannot be relied on in serious infections.
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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.