OBJECTIVE: To compare the safety and efficacy of sequential intravenous (IV) to oral (PO) moxifloxacin treatment against a standard antimicrobial regimen of IV piperacillin-tazobactam followed by PO amoxicillin-clavulanate for the treatment of adults with complicated intra-abdominal infection (cIAI). SUMMARY BACKGROUND DATA: cIAIs are commonly due to mixed aerobic and anaerobic bacteria and require both source control and broad-spectrum antibiotic therapy. METHODS: A prospective, double-blind, randomized, phase III comparative trial. Patients with cIAI were stratified by disease severity (APACHE II score) and randomized to either IV/PO moxifloxacin (400 mg q24 hours) or comparator (IV piperacillin-tazobactam [3.0/0.375 g q6 hours] +/- PO amoxicillin-clavulanate [800 mg/114 mg q12 hours]), each for 5 to 14 days. The primary efficacy variable was clinical cure rate at the test-of-cure visit (days 25-50). Bacteriologic outcomes were also determined. RESULTS: : Of 656 intent-to-treat patients, 379 (58%) were valid to assess efficacy (183 moxifloxacin, 196 comparator). Demographic and baseline medical characteristics were similar between the 2 groups. Clinical cure rates at test-of-cure were 80% (146 of 183) for moxifloxacin versus 78% (153 of 196) for comparator (95% confidence interval, -7.4%, 9.3%). The clinical cure rate at test-of-cure for hospital-acquired cIAI was higher with moxifloxacin (82%, 22 of 27) versus comparator (55%, 17 of 31; P = 0.05); rates were similar for community-acquired infections (80% [124 of 156] versus 82% [136 of 165], respectively). Bacterial eradication rates were 78% (117 of 150) with moxifloxacin versus 77% (126 of 163) in the comparator group (95% confidence interval, -9.9%, 8.7%). CONCLUSIONS: Once daily IV/PO moxifloxacin monotherapy was as least as effective as standard IV piperacillin-tazobactam/PO amoxicillin-clavulanate dosed multiple times daily for the treatment of cIAIs.
RCT Entities:
OBJECTIVE: To compare the safety and efficacy of sequential intravenous (IV) to oral (PO) moxifloxacin treatment against a standard antimicrobial regimen of IV piperacillin-tazobactam followed by PO amoxicillin-clavulanate for the treatment of adults with complicated intra-abdominal infection (cIAI). SUMMARY BACKGROUND DATA: cIAIs are commonly due to mixed aerobic and anaerobic bacteria and require both source control and broad-spectrum antibiotic therapy. METHODS: A prospective, double-blind, randomized, phase III comparative trial. Patients with cIAI were stratified by disease severity (APACHE II score) and randomized to either IV/PO moxifloxacin (400 mg q24 hours) or comparator (IV piperacillin-tazobactam [3.0/0.375 g q6 hours] +/- PO amoxicillin-clavulanate [800 mg/114 mg q12 hours]), each for 5 to 14 days. The primary efficacy variable was clinical cure rate at the test-of-cure visit (days 25-50). Bacteriologic outcomes were also determined. RESULTS: : Of 656 intent-to-treat patients, 379 (58%) were valid to assess efficacy (183 moxifloxacin, 196 comparator). Demographic and baseline medical characteristics were similar between the 2 groups. Clinical cure rates at test-of-cure were 80% (146 of 183) for moxifloxacin versus 78% (153 of 196) for comparator (95% confidence interval, -7.4%, 9.3%). The clinical cure rate at test-of-cure for hospital-acquired cIAI was higher with moxifloxacin (82%, 22 of 27) versus comparator (55%, 17 of 31; P = 0.05); rates were similar for community-acquired infections (80% [124 of 156] versus 82% [136 of 165], respectively). Bacterial eradication rates were 78% (117 of 150) with moxifloxacin versus 77% (126 of 163) in the comparator group (95% confidence interval, -9.9%, 8.7%). CONCLUSIONS: Once daily IV/PO moxifloxacin monotherapy was as least as effective as standard IV piperacillin-tazobactam/PO amoxicillin-clavulanate dosed multiple times daily for the treatment of cIAIs.
Authors: Joseph S Solomkin; John E Mazuski; Ellen J Baron; Robert G Sawyer; Avery B Nathens; Joseph T DiPiro; Timothy Buchman; E Patchen Dellinger; John Jernigan; Sherwood Gorbach; Anthony W Chow; John Bartlett Journal: Clin Infect Dis Date: 2003-09-25 Impact factor: 9.079
Authors: S M Cohn; P A Lipsett; T G Buchman; W G Cheadle; J W Milsom; S O'Marro; A E Yellin; S Jungerwirth; E V Rochefort; D C Haverstock; S F Kowalsky Journal: Ann Surg Date: 2000-08 Impact factor: 12.969
Authors: Yoav Golan; Laura A McDermott; Nilda V Jacobus; Ellie J C Goldstein; Sydney Finegold; Lizzie J Harrell; David W Hecht; Stephen G Jenkins; C Pierson; Richard Venezia; Jack Rihs; Paul Iannini; Sherwood L Gorbach; David R Snydman Journal: J Antimicrob Chemother Date: 2003-07-15 Impact factor: 5.790
Authors: John E Mazuski; Robert G Sawyer; Avery B Nathens; Joseph T DiPiro; Moshe Schein; Kenneth A Kudsk; Charles Yowler Journal: Surg Infect (Larchmt) Date: 2002 Impact factor: 2.150
Authors: Charles E Edmiston; Candace J Krepel; Gary R Seabrook; Lewis R Somberg; Atilla Nakeeb; Robert A Cambria; Jonathan B Towne Journal: Antimicrob Agents Chemother Date: 2004-03 Impact factor: 5.191
Authors: Anthony W Chow; Gerald A Evans; Avery B Nathens; Chad G Ball; Glen Hansen; Godfrey Km Harding; Andrew W Kirkpatrick; Karl Weiss; George G Zhanel Journal: Can J Infect Dis Med Microbiol Date: 2010 Impact factor: 2.471
Authors: Jan J De Waele; Jose M Tellado; Günter Weiss; Jeffrey Alder; Frank Kruesmann; Pierre Arvis; Tajamul Hussain; Joseph S Solomkin Journal: Surg Infect (Larchmt) Date: 2014-05-15 Impact factor: 2.150
Authors: Georg Cachovan; Rainer H Böger; Ina Giersdorf; Olaf Hallier; Thomas Streichert; Munif Haddad; Ursula Platzer; Gerhard Schön; Karl Wegscheider; Ingo Sobottka Journal: Antimicrob Agents Chemother Date: 2010-12-20 Impact factor: 5.191
Authors: Michael A West; Ernest E Moore; Michael B Shapiro; Avery B Nathens; Joseph Cuschieri; Jeffrey L Johnson; Brian G Harbrecht; Joseph P Minei; Paul E Bankey; Ronald V Maier Journal: J Trauma Date: 2008-12