Trial reportBMC infectious diseases2010
Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial.
Trial report in BMC infectious diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00136201 (A Multicenter, Randomized, Open-Label Comparison of the Safety and Efficacy of Tigecycline> vs Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Chinese Subjects), which is not on this map. Cited by 18 papers, 7 of them syntheses that pooled 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.
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.
A Multicenter, Randomized, Open-Label Comparison of the Safety and Efficacy of Tigecycline> vs Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Chinese Subjects
Who cites it
18 citing papers in PubMed, 7 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Efficacy, safety, and tolerability of antimicrobial agents for complicated intra-abdominal infection: a systematic review and network meta-analysis.BMC infectious diseases · 2023Pooled 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
- Pooled it
- Busting the Myth of "Static vs Cidal": A Systemic Literature Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Pooled it
- Empiric therapy for hospital-acquired, Gram-negative complicated intra-abdominal infection and complicated urinary tract infections: a systematic literature review of current and emerging treatment options.BMC infectious diseases · 2015Pooled it
- Excess deaths associated with tigecycline after approval based on noninferiority trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012Pooled it
- Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease.Antimicrobial agents and chemotherapy · 2011Pooled it
- Gram-negative bacterial infection randomized controlled trials (RCTs) in the 21st century: characteristics and evolution.JAC-antimicrobial resistance · 2026Review
- Optimal empiric treatment for KPC-2-producing Klebsiella pneumoniae infections in critically ill patients with normal or decreased renal function using Monte Carlo simulation.BMC infectious diseases · 2021Article
- Cost-effectiveness analysis comparing ceftazidime/avibactam (CAZ-AVI) as empirical treatment comparing to ceftolozane/tazobactam and to meropenem for complicated intra-abdominal infection (cIAI).Antimicrobial resistance and infection control · 2019Article
- 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 in China.Therapeutics and clinical risk management · 2018Article
- Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database.Yonsei medical journal · 2017Article
- Efficacy of intravenous tigecycline in patients withInfection and drug resistance · 2017Article
- The Antibiotic Drug Tigecycline: A Focus on its Promising Anticancer Properties.Frontiers in pharmacology · 2016Review
- Clinical Experience of Patients Receiving Doripenem-Containing Regimens for the Treatment of Healthcare-Associated Infections.PloS one · 2016Article
- Tigecycline use in critically ill patients: a multicentre prospective observational study in the intensive care setting.Intensive care medicine · 2014Observational
- In vitro activity of tigecycline against clinical isolates of carbapenem resistant Acinetobacter baumannii complex in Pretoria, South Africa.BMC research notes · 2012Article
- Clarification to the systematic review and meta-analysis involving tigecycline.Antimicrobial agents and chemotherapy · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 14 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTigecycline, a first-in-class broad-spectrum glycylcycline antibiotic, has broad-spectrum in vitro activity against bacteria commonly encountered in complicated intra-abdominal infections (cIAIs), including aerobic and facultative Gram-positive and Gram-negative bacteria and anaerobic bacteria. In the current trial, tigecycline was evaluated for safety and efficacy vs. imipenem/cilastatin in hospitalized Chinese patients with cIAIs.
methodsIn this phase 3, multicenter, open-label study, patients were randomly assigned to receive IV tigecycline or imipenem/cilastatin for </=2 weeks. The primary efficacy endpoints were clinical response at the test-of-cure visit (12-37 days after therapy) for the microbiologic modified intent-to-treat and microbiologically evaluable populations. Because the study was not powered to demonstrate non-inferiority between tigecycline and imipenem/cilastatin, no formal statistical analysis was performed. Two-sided 95% confidence intervals (CIs) were calculated for the response rates in each treatment group and for differences between treatment groups for descriptive purposes.
resultsOne hundred ninety-nine patients received >/=1 dose of study drug and comprised the modified intent-to-treat population. In the microbiologically evaluable population, 86.5% (45 of 52) of tigecycline- and 97.9% (47 of 48) of imipenem/cilastatin-treated patients were cured at the test-of-cure assessment (12-37 days after therapy); in the microbiologic modified intent-to-treat population, cure rates were 81.7% (49 of 60) and 90.9% (50 of 55), respectively. The overall incidence of treatment-emergent adverse events was 80.4% for tigecycline vs. 53.9% after imipenem/cilastatin therapy (P < 0.001), primarily due to gastrointestinal-related events, especially nausea (21.6% vs. 3.9%; P < 0.001) and vomiting (12.4% vs. 2.0%; P = 0.005).
conclusionsClinical cure rates for tigecycline were consistent with those found in global cIAI studies. The overall safety profile was also consistent with that observed in global studies of tigecycline for treatment of cIAI, as well as that observed in analyses of Chinese patients in those studies; no novel trends were observed.
trial registrationClinicalTrials.gov NCT00136201.
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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.