Article ; Online: Effect of intravenous clarithromycin in patients with sepsis, respiratory and multiple organ dysfunction syndrome: a randomized clinical trial.
Critical care (London, England)
2022 Volume 26, Issue 1, Page(s) 183
Abstract: Background: Clarithromycin may act as immune-regulating treatment in sepsis and acute respiratory dysfunction syndrome. However, clinical evidence remains inconclusive. We aimed to evaluate whether clarithromycin improves 28-day mortality among patients ...
| Abstract | Background: Clarithromycin may act as immune-regulating treatment in sepsis and acute respiratory dysfunction syndrome. However, clinical evidence remains inconclusive. We aimed to evaluate whether clarithromycin improves 28-day mortality among patients with sepsis, respiratory and multiple organ dysfunction syndrome. Methods: We conducted a multicenter, randomized, clinical trial in patients with sepsis. Participants with ratio of partial oxygen pressure to fraction of inspired oxygen less than 200 and more than 3 SOFA points from systems other than the respiratory function were enrolled between December 2017 and September 2019. Patients were randomized to receive 1 gr of clarithromycin or placebo intravenously once daily for 4 consecutive days. The primary endpoint was 28-day all-cause mortality. Secondary outcomes were 90-day mortality; sepsis response (defined as at least 25% decrease in SOFA score by day 7); sepsis recurrence; and differences in peripheral blood cell populations and leukocyte transcriptomics. Results: Fifty-five patients were allocated to each arm. By day 28, 27 (49.1%) patients in the clarithromycin and 25 (45.5%) in the placebo group died (risk difference 3.6% [95% confidence interval (CI) - 15.7 to 22.7]; P = 0.703, adjusted OR 1.03 [95%CI 0.35-3.06]; P = 0.959). There were no statistical differences in 90-day mortality and sepsis response. Clarithromycin was associated with lower incidence of sepsis recurrence (OR 0.21 [95%CI 0.06-0.68]; P = 0.012); significant increase in monocyte HLA-DR expression; expansion of non-classical monocytes; and upregulation of genes involved in cholesterol homeostasis. Serious and non-serious adverse events were equally distributed. Conclusions: Clarithromycin did not reduce mortality among patients with sepsis with respiratory and multiple organ dysfunction. Clarithromycin was associated with lower sepsis recurrence, possibly through a mechanism of immune restoration. Clinical trial registration clinicaltrials.gov identifier NCT03345992 registered 17 November 2017; EudraCT 2017-001056-55. |
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| MeSH term(s) | Administration, Intravenous ; Clarithromycin/pharmacology ; Clarithromycin/therapeutic use ; Humans ; Multiple Organ Failure/complications ; Multiple Organ Failure/drug therapy ; Oxygen/therapeutic use ; Sepsis/complications |
| Chemical Substances | Clarithromycin (H1250JIK0A) ; Oxygen (S88TT14065) |
| Language | English |
| Publishing date | 2022-06-18 |
| Publishing country | England |
| Document type | Journal Article ; Multicenter Study ; Randomized Controlled Trial |
| ZDB-ID | 2041406-7 |
| ISSN | 1466-609X ; 1364-8535 |
| ISSN (online) | 1466-609X |
| ISSN | 1364-8535 |
| DOI | 10.1186/s13054-022-04055-4 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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