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.
Looking for future studies?
Notify MeKey information
Conditions
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
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
Primary outcomes
-
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
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients
NCT02389036
Critical Illness, Cross Infection
Sydney, New South Wales, Australia
View Trial DetailsEarly Severe Illness TrAnslational BioLogy InformaticS in Humans
NCT05591924
ARDS, Cognition Disorders
London, Ontario, Canada
View Trial DetailsA Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
NCT04335539
Bacterial Infections, Bacterial Infections and Mycoses
Brussels, Belgium
View Trial DetailsStudy of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
NCT02714595
Bloodstream Infections (BSI), Complicated Urinary Tract Infection (cUTI)
Hartford, Connecticut, United States
View Trial Details