Trial reportCritical care (London, England)2022
Effect of intravenous clarithromycin in patients with sepsis, respiratory and multiple organ dysfunction syndrome: a randomized clinical trial.
Trial report in Critical care (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03345992 (A Double-Blind, Randomized, Placebo-Controlled Clinical Study of the Efficacy of Intravenous Clarithromycin as Adjunctive Treatment in Patients With Sepsis and Respiratory and Multiple Organ Dysfunction Syndrome), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind, Randomized, Placebo-Controlled Clinical Study of the Efficacy of Intravenous Clarithromycin as Adjunctive Treatment in Patients With Sepsis and Respiratory and Multiple Organ Dysfunction Syndrome
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- The impact of different antibiotic injection regimens on patients with severe infections: A meta-analysis.International wound journal · 2024Pooled it
- Molecular pathways driving clarithromycin benefit in community-acquired pneumonia: analysis of the ACCESS randomised trial.EBioMedicine · 2026Trial
- [Pharmacological immunomodulation in sepsis].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2026Review
- Clarithromycin for treating sepsis in adults.The Cochrane database of systematic reviews · 2026Article
- Integrated Transcriptomic Analysis of S100A8/A9 as a Key Biomarker and Therapeutic Target in Sepsis Pathogenesis and AI Drug Repurposing.International journal of molecular sciences · 2025Article
- Macrolide Therapy in Patients with Sepsis or Septic Shock: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2025Review
- Effect of mitochondrial translocator protein TSPO on LPS-induced cardiac dysfunction.Journal of advanced research · 2025Article
- IL-1R2 as a Precision Therapeutic Target in Sepsis: Molecular Insights into Immune Regulation.Current issues in molecular biology · 2025Article
- Association of the ROX index with mortality in sepsis patients: a retrospective study.Frontiers in medicine · 2025Article
- The type of pathogen is associated with organ failure and legacy dysfunction in patients with sepsis.Frontiers in immunology · 2025Article
- "Pleiotropic" Effects of Antibiotics: New Modulators in Human Diseases.Antibiotics (Basel, Switzerland) · 2024Review
- Antibiotic-Induced Immunosuppression-A Focus on Cellular Immunity.Antibiotics (Basel, Switzerland) · 2024Review
- Clinical Phenotyping for Prognosis and Immunotherapy Guidance in Bacterial Sepsis and COVID-19.Critical care explorations · 2024Article
- Assessment of De-Escalation of Empirical Antimicrobial Therapy in Medical Wards with Recognized Prevalence of Multi-Drug-Resistant Pathogens: A Multicenter Prospective Cohort Study in Non-ICU Patients with Microbiologically Documented Infection.Antibiotics (Basel, Switzerland) · 2024Article
- Biological basis of critical illness subclasses: from the bedside to the bench and back again.Critical care (London, England) · 2024Review
- Towards personalized medicine: a scoping review of immunotherapy in sepsis.Critical care (London, England) · 2024Article
- The Interplay between Antibiotics and the Host Immune Response in Sepsis: From Basic Mechanisms to Clinical Considerations: A Comprehensive Narrative Review.Antibiotics (Basel, Switzerland) · 2024Review
- The pathophysiology of sepsis and precision-medicine-based immunotherapy.Nature immunology · 2024Review
- Targeting the host response in sepsis: current approaches and future evidence.Critical care (London, England) · 2023Review
- Article
Corrections and comments
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Authors and funding
28 authors at 13 institutions in 5 countries.
Funding
Abstract
backgroundClarithromycin 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.
methodsWe 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.
resultsFifty-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.
conclusionsClarithromycin 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.