M. Xenopi Pulmonary Infection: A Randomized Clinical Trial Comparing Rifampin + Ethambutol + Either Clarithromycin or Moxifloxacin: The Camomy Study

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Andrejak, Claire | Veziris, N. | Lescure, F.-X. | Ampere, A. | Appere de Vecchi, C. | Audoly, C. | Blanc, F.-X. | Bergeron Lafaurie, A. | Bergot, E. | Bervar, J.-F. | Bildstein, F. | Bourdin, A. | Boutoille, D. | Bouvry, D. | Catherinot, E. | Claude, F. | Couturaud, F. | Degano, B. | Deslee, G. | Dupuy-Grasset, M. | Gagnadoux, F. | Georges, Marjorie | Godet, C. | Greib, C. | Jais, X. | Kerjouan, M. | Le Meunier, F. | Mal, H. | Maitre, B. | Marchand-Adam, S. | Marquette, C.-H. | Morel, H. | Morisse, H. | Nieves, A. | Philippe, B. | Priou, P. | Schlemmer, F. | Salaun, M. | Tattevin, P. | Tazi, A. | Cadranel, J. | Jounieaux, V.

Edité par CCSD ; American Thoracic Society -

Meeting abstract de l'International Conference of the American-Thoracic-Society (ATS 2024), May 17-22, 2024, San Diego, Calif.. International audience. Rationale: Mycobacterium xenopi (MX) pulmonary infections are associated with a poor prognosis. No data are available on 6-month (M6) culture conversion rate under antibiotics and optimal treatment is unknown. Only two randomized studies, which included 42 and 34 patients, have been conducted. No difference has been observed but power was low. Evidence based data are needed in order to improve management of MX pulmonary infections. Apart of rifampin, clarithromycin (CLA) and moxifloxacin (MXF) appear as drugs with the lowest minimal inhibitory concentration. Methods: We conducted an open randomized trial in patients with MX pulmonary disease in order to evaluate the M6 culture conversion rate under MX treatment (main objective) and to compare efficacy and tolerance of rifampin and ethambutol regimen combined with MXF or CLA (secondary objectives) with analysis in intention-to-treat (ITT) and in per protocol (PP). Results: Ninety-two patients were included (45 in CLA arm and 47 in MXF). Nine patients were secondary excluded (absence of M6 control sample). Finally, 44 patients (CLA) and 39 patients (MXF) were included in the analysis. These 83 patients (72.3% males, mean age 59 years old) had a mean of 3 positive samples at inclusion, with positive smear in 44%. In PP analysis, the M6 culture conversion was 85.5% (80.0% in MXF group and 90.2% in CLA group, p=0.17), and in ITT 88%, (93.2% in CLA group and, 82.1% in MXF group, p=0.11). No statistical difference was found in term of tolerance (p=0.55). The main severe adverse events were related to ethambutol and rifampicin. The Rhodes score, used to evaluate the digestive tolerance was not different between the 2 arms. Conclusion: In this randomized study, a regimen combining rifampin, ethambutol and either CLA or MXF reached a high culture conversion rate at 6 months. No difference was observed in term of efficacy between CLA and MXF containing regimen, even if there was a trend in favor of CLA.

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