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Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy--EORTC infectious diseases group trial XV.
J Clin Oncol. 2013 Mar 20; 31(9):1149-56.JC

Abstract

PURPOSE

This double-blind, multicenter trial compared the efficacy and safety of a single daily oral dose of moxifloxacin with oral combination therapy in low-risk febrile neutropenic patients with cancer.

PATIENTS AND METHODS

Inclusion criteria were cancer, febrile neutropenia, low risk of complications as predicted by a Multinational Association for Supportive Care in Cancer (MASCC) score > 20, ability to swallow, and ≤ one single intravenous dose of empiric antibiotic therapy before study drug treatment initiation. Early discharge was encouraged when a set of predefined criteria was met. Patients received either moxifloxacin (400 mg once daily) monotherapy or oral ciprofloxacin (750 mg twice daily) plus amoxicillin/clavulanic acid (1,000 mg twice daily). The trial was designed to show equivalence of the two drug regimens in terms of therapy success, defined as defervescence and improvement in clinical status during study drug treatment (< 10% difference).

RESULTS

Among the 333 patients evaluated in an intention-to-treat analysis, therapy success was observed in 80% of the patients administered moxifloxacin and in 82% of the patients administered combination therapy (95% CI for the difference, -10% to 8%, consistent with equivalence). Minor differences in tolerability, safety, and reasons for failure were observed. More than 50% of the patients in the two arms were discharged on protocol therapy, with 5% readmissions among those in either arm. Survival was similar (99%) in both arms.

CONCLUSION

Monotherapy with once daily oral moxifloxacin is efficacious and safe in low-risk febrile neutropenic patients identified with the help of the MASCC scoring system, discharged early, and observed as outpatients.

Authors+Show Affiliations

Universitätsklinikum Freiburg, Freiburg, Germany. kern@if-freiburg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23358983

Citation

Kern, Winfried V., et al. "Oral Antibiotics for Fever in Low-risk Neutropenic Patients With Cancer: a Double-blind, Randomized, Multicenter Trial Comparing Single Daily Moxifloxacin With Twice Daily Ciprofloxacin Plus Amoxicillin/clavulanic Acid Combination therapy--EORTC Infectious Diseases Group Trial XV." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 31, no. 9, 2013, pp. 1149-56.
Kern WV, Marchetti O, Drgona L, et al. Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy--EORTC infectious diseases group trial XV. J Clin Oncol. 2013;31(9):1149-56.
Kern, W. V., Marchetti, O., Drgona, L., Akan, H., Aoun, M., Akova, M., de Bock, R., Paesmans, M., Viscoli, C., & Calandra, T. (2013). Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy--EORTC infectious diseases group trial XV. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 31(9), 1149-56. https://doi.org/10.1200/JCO.2012.45.8109
Kern WV, et al. Oral Antibiotics for Fever in Low-risk Neutropenic Patients With Cancer: a Double-blind, Randomized, Multicenter Trial Comparing Single Daily Moxifloxacin With Twice Daily Ciprofloxacin Plus Amoxicillin/clavulanic Acid Combination therapy--EORTC Infectious Diseases Group Trial XV. J Clin Oncol. 2013 Mar 20;31(9):1149-56. PubMed PMID: 23358983.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy--EORTC infectious diseases group trial XV. AU - Kern,Winfried V, AU - Marchetti,Oscar, AU - Drgona,Lubos, AU - Akan,Hamdi, AU - Aoun,Mickel, AU - Akova,Murat, AU - de Bock,Robrecht, AU - Paesmans,Marianne, AU - Viscoli,Claudio, AU - Calandra,Thierry, Y1 - 2013/01/28/ PY - 2013/1/30/entrez PY - 2013/1/30/pubmed PY - 2013/5/7/medline SP - 1149 EP - 56 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 31 IS - 9 N2 - PURPOSE: This double-blind, multicenter trial compared the efficacy and safety of a single daily oral dose of moxifloxacin with oral combination therapy in low-risk febrile neutropenic patients with cancer. PATIENTS AND METHODS: Inclusion criteria were cancer, febrile neutropenia, low risk of complications as predicted by a Multinational Association for Supportive Care in Cancer (MASCC) score > 20, ability to swallow, and ≤ one single intravenous dose of empiric antibiotic therapy before study drug treatment initiation. Early discharge was encouraged when a set of predefined criteria was met. Patients received either moxifloxacin (400 mg once daily) monotherapy or oral ciprofloxacin (750 mg twice daily) plus amoxicillin/clavulanic acid (1,000 mg twice daily). The trial was designed to show equivalence of the two drug regimens in terms of therapy success, defined as defervescence and improvement in clinical status during study drug treatment (< 10% difference). RESULTS: Among the 333 patients evaluated in an intention-to-treat analysis, therapy success was observed in 80% of the patients administered moxifloxacin and in 82% of the patients administered combination therapy (95% CI for the difference, -10% to 8%, consistent with equivalence). Minor differences in tolerability, safety, and reasons for failure were observed. More than 50% of the patients in the two arms were discharged on protocol therapy, with 5% readmissions among those in either arm. Survival was similar (99%) in both arms. CONCLUSION: Monotherapy with once daily oral moxifloxacin is efficacious and safe in low-risk febrile neutropenic patients identified with the help of the MASCC scoring system, discharged early, and observed as outpatients. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/23358983/Oral_antibiotics_for_fever_in_low_risk_neutropenic_patients_with_cancer:_a_double_blind_randomized_multicenter_trial_comparing_single_daily_moxifloxacin_with_twice_daily_ciprofloxacin_plus_amoxicillin/clavulanic_acid_combination_therapy__EORTC_infectious_diseases_group_trial_XV_ L2 - https://ascopubs.org/doi/10.1200/JCO.2012.45.8109?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -