PMID- 20670293
OWN - NLM
STAT- MEDLINE
DCOM- 20101104
LR  - 20220330
IS  - 1469-0691 (Electronic)
IS  - 1198-743X (Linking)
VI  - 16
IP  - 8
DP  - 2010 Aug
TI  - A multicentre, open-label, randomized comparative study of tigecycline versus 
      ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects 
      with complicated intra-abdominal infections.
PG  - 1274-81
LID - 10.1111/j.1469-0691.2010.03122.x [doi]
AB  - Tigecycline (TGC) has demonstrated clinical efficacy and safety, in comparison 
      with imipenem/cilastatin in phase 3 clinical trials, for complicated 
      intra-abdominal infection (cIAI). The present study comprised a multicentre, 
      open-label, randomized study of TGC vs. ceftriaxone plus metronidazole (CTX/MET) 
      for the treatment of patients with cIAI. Eligible subjects were randomized (1:1) 
      to receive either an initial dose of TGC (100 mg) followed by 50 mg every 12 h or 
      CTX (2 g once daily) plus MET (1-2 g daily), for 4-14 days. The primary endpoint 
      was the clinical response in the clinically evaluable (CE) population at the test 
      of cure (TOC) assessment. Of 473 randomized subjects, 376 were CE. Among these, 
      clinical cure rates were 70.4% (133/189) with TGC vs. 74.3% (139/187) with 
      CTX/MET (95% CI -13.1 to 5.1; p 0.009 for non-inferiority). Clinical cure rates 
      for subjects with Acute Physiological and Chronic Health Evaluation II scores > 
      or =10 were 56.8% (21/37) with TGC vs. 58.3% (21/36) with CTX/MET. The 
      microbiologic response was similar between the two treatment arms, with 
      microbiological eradication at TOC achieved in 68.1% (94/138) of TGC-treated 
      subjects and 71.5% (98/137) of CTX/MET-treated subjects. (The most frequently 
      reported adverse events (AEs) for both treatment arms were nausea (TGC, 38.6% vs 
      CTX/MET, 27.7%) and vomiting (TGC, 23.3% vs CTX/MET, 17.7%). Overall 
      discontinuation rates as a result of an AE were 8.9% and 4.8% in TGC- and 
      comparator-treated subjects, respectively. The results obtained in the present 
      study demonstrate that TGC monotherapy is non-inferior to a combination regimen 
      of CTX/MET with respect to treating subjects with cIAI.
FAU - Towfigh, S
AU  - Towfigh S
AD  - Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA. 
      Shirin.towfigh@cshs.org
FAU - Pasternak, J
AU  - Pasternak J
FAU - Poirier, A
AU  - Poirier A
FAU - Leister, H
AU  - Leister H
FAU - Babinchak, T
AU  - Babinchak T
LA  - eng
SI  - ClinicalTrials.gov/NCT00195351
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Clin Microbiol Infect
JT  - Clinical microbiology and infection : the official publication of the European 
      Society of Clinical Microbiology and Infectious Diseases
JID - 9516420
RN  - 0 (Anti-Infective Agents)
RN  - 140QMO216E (Metronidazole)
RN  - 70JE2N95KR (Tigecycline)
RN  - 75J73V1629 (Ceftriaxone)
RN  - FYY3R43WGO (Minocycline)
SB  - IM
MH  - Abdomen/*microbiology
MH  - Anti-Infective Agents/*administration & dosage/adverse effects
MH  - Bacteria/isolation & purification
MH  - Bacterial Infections/*drug therapy
MH  - Ceftriaxone/*administration & dosage/adverse effects
MH  - Drug Therapy, Combination/methods
MH  - Female
MH  - Gastrointestinal Diseases/*drug therapy
MH  - Humans
MH  - Male
MH  - Metronidazole/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Minocycline/administration & dosage/adverse effects/*analogs & derivatives
MH  - Tigecycline
MH  - Treatment Outcome
EDAT- 2010/07/31 06:00
MHDA- 2010/11/05 06:00
CRDT- 2010/07/31 06:00
PHST- 2010/07/31 06:00 [entrez]
PHST- 2010/07/31 06:00 [pubmed]
PHST- 2010/11/05 06:00 [medline]
AID - S1198-743X(14)64230-0 [pii]
AID - 10.1111/j.1469-0691.2010.03122.x [doi]
PST - ppublish
SO  - Clin Microbiol Infect. 2010 Aug;16(8):1274-81. doi: 
      10.1111/j.1469-0691.2010.03122.x.