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J Antimicrob Chemother. 2014 Apr;69(4):1111-8. doi: 10.1093/jac/dkt475. Epub 2013 Nov 28.

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

Author information

1
4th Department of Internal Medicine, University of Athens, Medical School, 12462 Athens, Greece.

Abstract

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.

KEYWORDS:

bacteraemia; hospitalization costs; intra-abdominal infection; pyelonephritis; respiratory distress syndrome

PMID:
24292991
DOI:
10.1093/jac/dkt475
[Indexed for MEDLINE]

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