Intravenous Clarithromycin in Septic Syndrome

NCT00297674 | Completed Phase 4

• 1 other identifier: ACA-GREC-2004-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this clinical trial is to clarify the clinical efficacy of clarithromycin as immunotherapy for the management of septic syndrome by ventilator-associated pneumonia.

Conditions

Sepsis; Ventilator Associated Pneumonia

Keywords

clarithromycin; sepsis; immunomodulation

Outcome Measures

Primary Outcomes (8)

• Estimation of crude mortality by any reason of each study group

• Estimation of attributable mortality by VAP of each study group

• 7-day mortality rate of each group

• 28-mortality rate of each group

• Rate of progression to multiple organ failure and septic shock (and number of failing organs) of each study group

• Time to progression to multiple organ failure and septic shock of each study group

• Days of resolution of VAP

• Days in ICU after diagnosis of VAP

Secondary Outcomes (1)

• Influence of administration of clarithromycin on systemic inflammatory response

Interventions

Intravenous Clarithromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent provided by first or second degree relatives;
• intubation and mechanical ventilation at least 48 hours prior to enrolment; c) age of patients equal to or more than 18 years;
• d) diagnosis of Ventilator Associated Pneumonia; and e) signs of sepsis

You may not qualify if:

• neutropenia, defined as less than 500 neutrophils/mm3;
• HIV infection;
• oral intake of corticosteroids at a dose equal to or higher than 1mg/kg equivalent prednisone for a period greater than one month;
• administration of drotrecogin alpha the last five days prior to enrolment; and e) atrioventricular block of second or third degree.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (3)

1st Department of Critical Care, Evangelismos General Hospital

Athens, 106 72, Greece

Location

2nd Department of Critical Care, ATTIKON University Hospital

Athens, 124 64, Greece

Location

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, 124 64, Greece

Location

Related Publications (8)

• Giamarellos-Bourboulis EJ, Adamis T, Laoutaris G, Sabracos L, Koussoulas V, Mouktaroudi M, Perrea D, Karayannacos PE, Giamarellou H. Immunomodulatory clarithromycin treatment of experimental sepsis and acute pyelonephritis caused by multidrug-resistant Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2004 Jan;48(1):93-9. doi: 10.1128/AAC.48.1.93-99.2004.

  PMID: 14693524 BACKGROUND

• Giamarellos-Bourboulis EJ, Baziaka F, Antonopoulou A, Koutoukas P, Kousoulas V, Sabracos L, Panagou C, Perrea D, Giamarellou H. Clarithromycin co-administered with amikacin attenuates systemic inflammation in experimental sepsis with Escherichia coli. Int J Antimicrob Agents. 2005 Feb;25(2):168-72. doi: 10.1016/j.ijantimicag.2004.08.018.

  PMID: 15664488 BACKGROUND

• Giamarellos-Bourboulis E, Adamis T, Sabracos L, Raftogiannis M, Baziaka F, Tsaganos T, Koutoukas P, Plachouras D, Karayannacos P, Giamarellou H. Clarithromycin: immunomodulatory therapy of experimental sepsis and acute pyelonephritis by Escherichia coli. Scand J Infect Dis. 2005;37(1):48-54. doi: 10.1080/00365540510026832.

  PMID: 15764190 BACKGROUND

• Vittoros V, Kyriazopoulou E, Lada M, Tsangaris I, Koutelidakis IM, Giamarellos-Bourboulis EJ. Soluble fms-like tyrosine kinase 1, placental growth factor and procalcitonin as biomarkers of gram-negative sepsis: Analysis through a derivation and a validation cohort. Medicine (Baltimore). 2021 Nov 5;100(44):e27662. doi: 10.1097/MD.0000000000027662.

  PMID: 34871241 DERIVED

• Karakike E, Kyriazopoulou E, Tsangaris I, Routsi C, Vincent JL, Giamarellos-Bourboulis EJ. The early change of SOFA score as a prognostic marker of 28-day sepsis mortality: analysis through a derivation and a validation cohort. Crit Care. 2019 Nov 29;23(1):387. doi: 10.1186/s13054-019-2665-5.

  PMID: 31783881 DERIVED

• Strouvalis I, Routsi C, Adamopoulou M, Raftogiannis M, Renieris G, Orfanos SE, Kotanidou A, Sabracos L, Giamarellos-Bourboulis EJ. Early increase of VEGF-A is associated with resolution of ventilator-associated pneumonia: Clinical and experimental evidence. Respirology. 2018 Oct;23(10):942-949. doi: 10.1111/resp.13320. Epub 2018 May 9.

  PMID: 29741298 DERIVED

• Tsaganos T, Raftogiannis M, Pratikaki M, Christodoulou S, Kotanidou A, Papadomichelakis E, Armaganidis A, Routsi C, Giamarellos-Bourboulis EJ. Clarithromycin Leads to Long-Term Survival and Cost Benefit in Ventilator-Associated Pneumonia and Sepsis. Antimicrob Agents Chemother. 2016 May 23;60(6):3640-6. doi: 10.1128/AAC.02974-15. Print 2016 Jun.

  PMID: 27044546 DERIVED

• Giamarellos-Bourboulis EJ. Immunomodulatory therapies for sepsis: unexpected effects with macrolides. Int J Antimicrob Agents. 2008 Nov;32 Suppl 1:S39-43. doi: 10.1016/j.ijantimicag.2008.06.004. Epub 2008 Aug 15.

  PMID: 18707849 DERIVED

MeSH Terms

Conditions

Sepsis; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes

Study Officials

• Evangelos J Giamarellos-Bourboulis, MD, PhD

  University of Athens, Medical School, Greece

  STUDY CHAIR

• Helen Giamarellou, MD, PhD

  University of Athens, Medical School, Greece

  PRINCIPAL INVESTIGATOR

• Apostolos Armaganidis, MD, PhD

  University of Athens, Medical School, Greece

  PRINCIPAL INVESTIGATOR

• Charis Roussos, MD, PhD

  University of Athens, Medical School, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 27, 2006
• First Posted: February 28, 2006
• Study Start: June 1, 2004
• Study Completion: December 1, 2005
• Last Updated: February 28, 2006

Record last verified: 2004-07

Locations

GR (3)