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Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections.
Ann Surg. 2006 Aug; 244(2):204-11.AnnS

Abstract

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+Show Affiliations

Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH 44109-1998, USA. mmalangoni@metrohealth.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16858182

Citation

Malangoni, Mark A., et al. "Randomized Controlled Trial of Moxifloxacin Compared With Piperacillin-tazobactam and Amoxicillin-clavulanate for the Treatment of Complicated Intra-abdominal Infections." Annals of Surgery, vol. 244, no. 2, 2006, pp. 204-11.
Malangoni MA, Song J, Herrington J, et al. Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections. Ann Surg. 2006;244(2):204-11.
Malangoni, M. A., Song, J., Herrington, J., Choudhri, S., & Pertel, P. (2006). Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections. Annals of Surgery, 244(2), 204-11.
Malangoni MA, et al. Randomized Controlled Trial of Moxifloxacin Compared With Piperacillin-tazobactam and Amoxicillin-clavulanate for the Treatment of Complicated Intra-abdominal Infections. Ann Surg. 2006;244(2):204-11. PubMed PMID: 16858182.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections. AU - Malangoni,Mark A, AU - Song,James, AU - Herrington,Janet, AU - Choudhri,Shurjeel, AU - Pertel,Peter, PY - 2006/7/22/pubmed PY - 2006/9/6/medline PY - 2006/7/22/entrez SP - 204 EP - 11 JF - Annals of surgery JO - Ann. Surg. VL - 244 IS - 2 N2 - 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. SN - 0003-4932 UR - https://www.unboundmedicine.com/medline/citation/16858182/Randomized_controlled_trial_of_moxifloxacin_compared_with_piperacillin_tazobactam_and_amoxicillin_clavulanate_for_the_treatment_of_complicated_intra_abdominal_infections_ L2 - http://Insights.ovid.com/pubmed?pmid=16858182 DB - PRIME DP - Unbound Medicine ER -