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Moxifloxacin monotherapy compared to amoxicillin-clavulanate plus roxithromycin for nonsevere community-acquired pneumonia in adults with risk factors

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Abstract

The objective of this study was to assess the efficacy and safety of moxifloxacin versus amoxicillin-clavulanate plus roxithromycin (comparator) in adult community-acquired pneumonia (CAP) patients with risk factors. In this comparative, randomized, multicenter, open-label study, patients hospitalized for CAP received a 10-day oral treatment with either moxifloxacin (400 mg o.d.) or amoxicillin-clavulanate (1,000/125 mg t.i.d.) plus roxithromycin (150 mg b.i.d.). Clinical and bacteriological outcomes were assessed during test of cure and follow-up visits (5–7 days and 21–28 days after the end of treatment, respectively). Of 349 randomized patients, 346 were included in the intent-to-treat analysis and 289 in the per-protocol analysis. Their baseline characteristics were comparable. The most frequent risk factors for mortality were age >65 years (50.0%), alcoholism (23.1%), and comorbidities (50.6%); chronic obstructive pulmonary disease (COPD) (25.4%) and diabetes mellitus (13.6%) were the most common associated comorbidities. A causative pathogen was documented in 66 of 346 (19.1%) of the patients (including 21 with positive blood cultures). Respective per-protocol clinical success rates at test-of-cure (primary efficacy endpoint) for moxifloxacin and comparator were 131 of 151 (86.8%) and 120 of 138 (87.0%), with a 95% confidence interval (CI) of −8.0–7.6 for the difference. Bacteriological success rates (eradication) were 23 of 30 (76.7%) and 23 of 31 (74.2%); rates for patients with positive blood cultures were 10 of 14 and 4 of 6. Persistent clinical success rates at follow-up were 118 of 120 (98.3%) and 102 of 106 (96.2%), with a 95%CI of −2.2–6.4 for the difference. The intent-to-treat analysis confirmed these results. Adverse events associated with moxifloxacin and the comparator drug were reported for 42 of 171 (24.6%) and 50 of 175 (28.6%) of the patients, respectively, and comprised predominantly digestive disorders, which occurred in 9.4% and 21.1%. On the basis of these results, once-daily oral moxifloxacin alone is as effective as amoxicillin-clavulanate plus roxithromycin for the treatment of CAP in patients with risk factors.

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Acknowledgements

This work was supported by a research grant from Bayer Pharma, France. The corresponding author, as principal investigator, received grants for the coordination of the study. He and the other members of the IZIPAC Study Group Scientific Committee received grants for their review and individual validation of the patient cases. These financial sources have not in any way had an impact on either the selection and interpretation of published data or the preparation of this manuscript. Members of the IZIPAC Study Group: Scientific Committee: C. Brambilla, M. Garre, H. Portier, and P. Zuck. Investigators: F. Al Freijat, H. Berard, F. Benhamou, F. Bonnaud, A. Bosseray, O. Bouchard, J. Boyer, P. Brouqui, R. Cevallos, J.M. Chavaillon, C. Chidiac, H. De Cremoux, P. Dellamonica, B. Desurmont-Salasc, P. Duguet, M. Dupon, B. Duvert, D. Debieuvre, M.C. Dombret, P. Dore, J.M. Estavoyer, L. Falchero, E. Fournier, M. Garre, D. Gora, F. Goutorbe, J.R. Harle, D. Herman, J. Hermann, B. Herer, A. Huchon, R. Jaussaud, C. Jordy, H. Jullian, S. Khatibi, R. Lachaussée, A. Lagier, T. Langin, P. Laurent, T. Lazard, F.X. Lebas, F. Lecomte, P. Leophonte, G. Lepeu, B. Lorcerie, P. Loste, D. Malvy, G. Mangiapan, Y. Martinet, T. May, P. Meekel, V. Meunier, D. Merrien, P. Morlat, M. Mornet, G. Nouvet, F. Paganin, J.C. Pellegrin, H. Portier, P. Poubeau, T. Prazuck, A. Proust, A. Prud’homme, F. Roblot, J. Rottner, D. Salmon, J. Seigneur, T. Simon, J.P. Stahl, M. Thomas, A. Tonnel, J.P. Vagneur, C. Verkindre, P. Vinceneux, M.A. Vincent, P.M. Viso, L. Vives, P. Vivet, Y. Zein, and P. Zuck

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Authors and Affiliations

  1. CHU de Dijon, Hôpital du Bocage, BP 1542, 21034, Dijon Cedex, France

    H. Portier

  2. CHR de Grenoble, BP 217, 38043, Grenoble Cedex, France

    C. Brambilla

  3. CHU La Cavale Blanche, Boulevard Tanguy Prigent, 29609, Brest Cedex, France

    M. Garre

  4. Centre Hospitalier Sud-Réunion, BP 350, 97448, Saint Pierre Cedex, La Réunion, France

    F. Paganin & P. Poubeau

  5. CHR de Metz-Thionville, 28–32 rue du XXème Corps Américain, BP 90770, 57019, Metz Cedex, France

    P. Zuck

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  1. H. Portier
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  2. C. Brambilla
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  3. M. Garre
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  4. F. Paganin
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  5. P. Poubeau
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  6. P. Zuck
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Correspondence to H. Portier.

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Portier, H., Brambilla, C., Garre, M. et al. Moxifloxacin monotherapy compared to amoxicillin-clavulanate plus roxithromycin for nonsevere community-acquired pneumonia in adults with risk factors. Eur J Clin Microbiol Infect Dis 24, 367–376 (2005). https://doi.org/10.1007/s10096-005-1347-1

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