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OpenTrials
Completed

NCT Number: NCT00297674

Intravenous Clarithromycin in Septic Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1st Department of Critical Care, Evangelismos General Hospital, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Intravenous Clarithromycin

Drug

Primary outcomes

  1. Estimation of crude mortality by any reason of each study group

  2. Estimation of attributable mortality by VAP of each study group

  3. 7-day mortality rate of each group

  4. 28-mortality rate of each group

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

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

  7. Days of resolution of VAP

  8. Days in ICU after diagnosis of VAP

Secondary outcomes

  1. Influence of administration of clarithromycin on systemic inflammatory response

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

Clarithromycin as Immunomodulatory Therapy for the Management of Septic Syndrome by Ventilator-Associated Pneumonia

Important dates

Study start
2004
Study completion
2005
First posted
Feb 28, 2006
Registry last updated
Feb 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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