Titre :

Effects of Long-term Norfloxacin Therapy in Patients with Advanced Cirrhosis.

Auteur(s) :

Moreau, Richard [Auteur]
Centre de recherche sur l'Inflammation [CRI (UMR_S_1149 / ERL_8252 / U1149)]
Elkrief, Laure [Auteur]
Bureau, Christophe [Auteur]
Perarnau, Jean-Marc [Auteur]
Thevenot, Thierry [Auteur]
Saliba, Faouzi [Auteur]
Louvet, Alexandre [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Nahon, Pierre [Auteur]
Génomique Fonctionnelle des Tumeurs Solides [U1162]
Lannes, Adrien [Auteur]
Anty, Rodolphe [Auteur]
Hillaire, Sophie [Auteur]
Pasquet, Blandine [Auteur]
Ozenne, Violaine [Auteur]
Rudler, Marika [Auteur]
Ollivier-Hourmand, Isabelle [Auteur]
Robic Marie, Angele [Auteur]
D'alteroche, Louis [Auteur]
Di Martino, Vincent [Auteur]
Ripault, Marie-Pierre [Auteur]
Pauwels, Arnaud [Auteur]
Grange, Jean-Didier [Auteur]
Carbonell, Nicolas [Auteur]
Bronowicki, Jean-Pierre [Auteur]
Université de Lorraine [UL]
Payance, Audrey [Auteur]
Rautou, Pierre-Emmanuel [Auteur]
Valla, Dominique [Auteur]
Centre de recherche sur l'Inflammation [CRI (UMR_S_1149 / ERL_8252 / U1149)]
Gault, Nathalie [Auteur]
Centre d'investigation Clinique [CHU Bichat] - Épidémiologie clinique [CIC 1425]
Lebrec, Didier [Auteur]

Titre de la revue :

Gastroenterology

Nom court de la revue :

Gastroenterology

Numéro :

155

Pagination :

1816-1827.e9

Date de publication :

2018-12

Mot(s)-clé(s) :

Inflammation
NORFLOCIR Trial
Liver-Related Complications
Risk Factor

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Background & Aims: There is debate over the effects of long-term oral fluoroquinolone therapy in patients with advanced cirrhosis. We performed a randomized controlled trial to evaluate the effects of long-term treatment ...
Lire la suite >Background & Aims: There is debate over the effects of long-term oral fluoroquinolone therapy in patients with advanced cirrhosis. We performed a randomized controlled trial to evaluate the effects of long-term treatment with the fluoroquinolone norfloxacin on survival of patients with cirrhosis. Methods: We performed a double-blind trial of 291 patients with Child-Pugh class C cirrhosis who had not received recent fluoroquinolone therapy. The study was performed at 18 clinical sites in France from April 2010 through November 2014. Patients were randomly assigned to groups given 400 mg norfloxacin (n = 144) or placebo (n = 147) once daily for 6 months. Patients were evaluated monthly for the first 6 months and at 9 months and 12 months thereafter. The primary outcome was 6-month mortality, estimated by the Kaplan–Meier method, censoring spontaneous bacterial peritonitis, liver transplantation, or loss during follow-up. Results: The Kaplan–Meier estimate for 6-month mortality was 14.8% for patients receiving norfloxacin and 19.7% for patients receiving placebo (P = .21). In competing risk analysis that took liver transplantation into account, the cumulative incidence of death at 6 months was significantly lower in the norfloxacin group than in the placebo group (subdistribution hazard ratio, 0.59; 95% confidence interval, 0.35–0.99). The subdistribution hazard ratio for death at 6 months with norfloxacin vs placebo was 0.35 (95% confidence interval, 0.13–0.93) in patients with ascites fluid protein concentrations <15 g/L and 1.39 (95% confidence interval, 0.42–4.57) in patients with ascites fluid protein concentrations ≥15 g/L. Norfloxacin significantly decreased the incidence of any and Gram-negative bacterial infections without increasing infections caused by Clostridium difficile or multiresistant bacteria. Conclusions: In a randomized controlled trial of patients with advanced cirrhosis without recent fluoroquinolone therapy, norfloxacin did not reduce 6-month mortality, estimated by the Kaplan–Meier method. Norfloxacin, however, appears to increase survival of patients with low ascites fluid protein concentrations. ClinicalTrials.gov ID: NCT01037959.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Inserm
Université de Lille
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Équipe(s) de recherche :

Inflammatory digestive disease : pathophysiology and therapeutic targets developement

Date de dépôt :

2019-03-01T14:34:34Z
2024-02-01T09:39:23Z