Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 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

Evangelos J Giamarellos-Bourboulis  1 , Vassiliki Mylona, Anastasia Antonopoulou, Iraklis Tsangaris, Ioannis Koutelidakis, Androniki Marioli, Maria Raftogiannis, Petros Kopterides, Korina Lymberopoulou, Maria Mouktaroudi, Christos Papageorgiou, Basileios Papaziogas, Antonia-Panagiota Georgopoulou, Thomas Tsaganos, Evangelos Papadomichelakis, Charalambos Gogos, Malvina Ladas, Athina Savva, Aimilia Pelekanou, Fotini Baziaka, Pantelis Koutoukas, Theodora Kanni, Aikaterini Spyridaki, Nikolaos Maniatis, Nikolaos Pelekanos, Antigone Kotsaki, Ilia Vaki, Emmanuel E Douzinas, Georgios Koratzanis, Apostolos Armaganidis
Affiliations
Randomized Controlled Trial

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

Evangelos J Giamarellos-Bourboulis et al. J Antimicrob Chemother. 2014 Apr.

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.

PubMed Disclaimer

Publication types

MeSH terms