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Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study.
Infection. 2013 Feb; 41(1):175-86.I

Abstract

OBJECTIVE

The aim was to compare the efficacy and safety of two antibiotic regimens in patients with diabetic foot infections (DFIs).

METHODS

Data of a subset of patients enrolled in the RELIEF trial with DFIs requiring surgery and antibiotics were evaluated retrospectively. DFI was diagnosed on the basis of the modified Wagner, University of Texas, and PEDIS classification systems. Patients were randomized to receive either intravenous/oral moxifloxacin (MXF, N = 110) 400 mg q.d. or intravenous piperacillin/tazobactam 4.0/0.5 g t.d.s. followed by oral amoxicillin/clavulanate 875/125 mg b.d. (PIP/TAZ-AMC, N = 96), for 7-21 days until the end of treatment (EOT). The primary endpoint was clinical cure rates in the per-protocol (PP) population at the test-of-cure visit (TOC, 14-28 days after EOT).

RESULTS

There were no significant differences between the demographic characteristics of PP patients in either treatment group. At TOC, MXF and PIP/TAZ-AMC had similar efficacy in both the PP and intent-to-treat (ITT) populations: MXF: 76.4 % versus PIP/TAZ-AMC: 78.1 %; 95 % confidence interval (CI) -14.5 %, 9.0 % in the PP population; MXF: 69.9 % versus PIP/TAZ-AMC: 69.1 %; 95 % CI -12.4 %, 12.1 % in the ITT population. The overall bacteriological success rates were similar in both treatment groups (MXF: 71.7 % versus PIP/TAZ-AMC: 71.8 %; 95 % CI -16.9 %, 10.7 %). A similar proportion of patients (ITT population) experienced any adverse events in both treatment groups (MXF: 30.9 % versus PIP/TAZ-AMC: 31.8 %, respectively). Death occurred in three MXF-treated patients and one PIP/TAZ-AMC-treated patient; these were unrelated to the study drugs.

CONCLUSION

Moxifloxacin has shown favorable safety and efficacy profiles in DFI patients and could be an alternative antibiotic therapy in the management of DFI.

CLINICAL TRIAL

NCT00402727.

Authors+Show Affiliations

Department of Internal Medicine, Division of Endocrinology, CARIM and CAPHRI Institute, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands. n.schaper@mumc.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23180507

Citation

Schaper, N C., et al. "Efficacy and Safety of IV/PO Moxifloxacin and IV Piperacillin/tazobactam Followed By PO Amoxicillin/clavulanic Acid in the Treatment of Diabetic Foot Infections: Results of the RELIEF Study." Infection, vol. 41, no. 1, 2013, pp. 175-86.
Schaper NC, Dryden M, Kujath P, et al. Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. Infection. 2013;41(1):175-86.
Schaper, N. C., Dryden, M., Kujath, P., Nathwani, D., Arvis, P., Reimnitz, P., Alder, J., & Gyssens, I. C. (2013). Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. Infection, 41(1), 175-86. https://doi.org/10.1007/s15010-012-0367-x
Schaper NC, et al. Efficacy and Safety of IV/PO Moxifloxacin and IV Piperacillin/tazobactam Followed By PO Amoxicillin/clavulanic Acid in the Treatment of Diabetic Foot Infections: Results of the RELIEF Study. Infection. 2013;41(1):175-86. PubMed PMID: 23180507.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. AU - Schaper,N C, AU - Dryden,M, AU - Kujath,P, AU - Nathwani,D, AU - Arvis,P, AU - Reimnitz,P, AU - Alder,J, AU - Gyssens,I C, Y1 - 2012/11/23/ PY - 2012/08/09/received PY - 2012/11/06/accepted PY - 2012/11/28/entrez PY - 2012/11/28/pubmed PY - 2013/7/19/medline SP - 175 EP - 86 JF - Infection JO - Infection VL - 41 IS - 1 N2 - OBJECTIVE: The aim was to compare the efficacy and safety of two antibiotic regimens in patients with diabetic foot infections (DFIs). METHODS: Data of a subset of patients enrolled in the RELIEF trial with DFIs requiring surgery and antibiotics were evaluated retrospectively. DFI was diagnosed on the basis of the modified Wagner, University of Texas, and PEDIS classification systems. Patients were randomized to receive either intravenous/oral moxifloxacin (MXF, N = 110) 400 mg q.d. or intravenous piperacillin/tazobactam 4.0/0.5 g t.d.s. followed by oral amoxicillin/clavulanate 875/125 mg b.d. (PIP/TAZ-AMC, N = 96), for 7-21 days until the end of treatment (EOT). The primary endpoint was clinical cure rates in the per-protocol (PP) population at the test-of-cure visit (TOC, 14-28 days after EOT). RESULTS: There were no significant differences between the demographic characteristics of PP patients in either treatment group. At TOC, MXF and PIP/TAZ-AMC had similar efficacy in both the PP and intent-to-treat (ITT) populations: MXF: 76.4 % versus PIP/TAZ-AMC: 78.1 %; 95 % confidence interval (CI) -14.5 %, 9.0 % in the PP population; MXF: 69.9 % versus PIP/TAZ-AMC: 69.1 %; 95 % CI -12.4 %, 12.1 % in the ITT population. The overall bacteriological success rates were similar in both treatment groups (MXF: 71.7 % versus PIP/TAZ-AMC: 71.8 %; 95 % CI -16.9 %, 10.7 %). A similar proportion of patients (ITT population) experienced any adverse events in both treatment groups (MXF: 30.9 % versus PIP/TAZ-AMC: 31.8 %, respectively). Death occurred in three MXF-treated patients and one PIP/TAZ-AMC-treated patient; these were unrelated to the study drugs. CONCLUSION: Moxifloxacin has shown favorable safety and efficacy profiles in DFI patients and could be an alternative antibiotic therapy in the management of DFI. CLINICAL TRIAL: NCT00402727. SN - 1439-0973 UR - https://www.unboundmedicine.com/medline/citation/23180507/Efficacy_and_safety_of_IV/PO_moxifloxacin_and_IV_piperacillin/tazobactam_followed_by_PO_amoxicillin/clavulanic_acid_in_the_treatment_of_diabetic_foot_infections:_results_of_the_RELIEF_study_ L2 - https://doi.org/10.1007/s15010-012-0367-x DB - PRIME DP - Unbound Medicine ER -