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Effect of clarithromycin in patients with suspected Gram-negative sepsis: results of a randomized controlled trial.

TitleEffect of clarithromycin in patients with suspected Gram-negative sepsis: results of a randomized controlled trial.
Publication TypeJournal Article
Year of Publication2014
AuthorsGiamarellos-Bourboulis, E. J., Mylona V., Antonopoulou A., Tsangaris I., Koutelidakis I., Marioli A., Raftogiannis M., Kopterides P., Lymberopoulou K., Mouktaroudi M., Papageorgiou C., Papaziogas B., Georgopoulou A-P., Tsaganos T., Papadomichelakis E., Gogos C., Ladas M., Savva A., Pelekanou A., Baziaka F., Koutoukas P., Kanni T., Spyridaki A., Maniatis N., Pelekanos N., Kotsaki A., Vaki I., Douzinas E. E., Koratzanis G., & Armaganidis A.
JournalJ Antimicrob Chemother
Date Published2014 Apr
KeywordsAdministration, Intravenous, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Clarithromycin, Double-Blind Method, Female, Gram-Negative Bacterial Infections, Health Care Costs, Humans, Male, Middle Aged, Placebos, Prospective Studies, Sepsis, Survival Analysis, Treatment Outcome, Young Adult

BACKGROUND: A previous randomized study showed that clarithromycin decreases the risk of death due to ventilator-associated pneumonia and shortens the time until infection resolution. The efficacy of clarithromycin was tested in a larger population with sepsis.METHODS: Six hundred patients with systemic inflammatory response syndrome due to acute pyelonephritis, acute intra-abdominal infections or primary Gram-negative bacteraemia were enrolled in a double-blind, randomized, multicentre trial. Clarithromycin (1 g) was administered intravenously once daily for 4 days consecutively in 302 patients; another 298 patients were treated with placebo. Mortality was the primary outcome; resolution of infection and hospitalization costs were the secondary outcomes.RESULTS: The groups were well matched for demographics, disease severity, microbiology and appropriateness of the administered antimicrobials. Overall 28 day mortality was 17.1% (51 deaths) in the placebo arm and 18.5% (56 deaths) in the clarithromycin arm (P = 0.671). Nineteen out of 26 placebo-treated patients with septic shock and multiple organ dysfunctions died (73.1%) compared with 15 out of 28 clarithromycin-treated patients (53.6%, P = 0.020). The median time until resolution of infection was 5 days in both arms. In the subgroup with severe sepsis/shock, this was 10 days in the placebo arm and 6 days in the clarithromycin arm (P = 0.037). The cost of hospitalization was lower after treatment with clarithromycin (P = 0.044). Serious adverse events were observed in 1.3% and 0.7% of placebo- and clarithromycin-treated patients, respectively (P = 0.502).CONCLUSIONS: Intravenous clarithromycin did not affect overall mortality; however, administration shortened the time to resolution of infection and decreased the hospitalization costs.

Alternate JournalJ. Antimicrob. Chemother.
PubMed ID24292991


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