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Intravenous Clarithromycin in Septic Syndrome

NCT ID: NCT00297674

Last Updated: 2006-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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The rationale of the trial is based on the favorable results of experimental studies of sepsis by multidrug-resistant Pseudomonas aeruginosa and by susceptible Escherichia coli in rabbits where clarithromycin was administered intravenously. Data from these latter studies suggest that administration of clarithromycin extended survival and attenuated systemic inflammatory response. Their major endpoint was successful immunotherapy achieved when clarithromycin was administered on presentation of symptoms of sepsis-induced pulmonary edema; on the contrary, former clinical trials for immunotherapies of sepsis were based on animal studies where the under evolution immunomodulator was administered before bacterial challenge. The efficacy of administration of clarithromycin upon presentation of septic syndrome in animal studies, renders its application promising in the clinical field.

Conditions

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Sepsis Ventilator Associated Pneumonia

Keywords

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clarithromycin sepsis immunomodulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Intravenous Clarithromycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. written informed consent provided by first or second degree relatives;
2. 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Principal Investigators

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Evangelos J Giamarellos-Bourboulis, MD, PhD

Role: STUDY_CHAIR

University of Athens, Medical School, Greece

Helen Giamarellou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Athens, Medical School, Greece

Apostolos Armaganidis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Athens, Medical School, Greece

Charis Roussos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Athens, Medical School, Greece

Locations

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1st Department of Critical Care, Evangelismos General Hospital

Athens, , Greece

Site Status

2nd Department of Critical Care, ATTIKON University Hospital

Athens, , Greece

Site Status

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 14693524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15664488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15764190 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34871241 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31783881 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29741298 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27044546 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18707849 (View on PubMed)

Other Identifiers

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ACA-GREC-2004-01

Identifier Type: -

Identifier Source: org_study_id