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Intravenous Clarithromycin in Septic Syndrome

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00297674
Enrollment
200
Registered
2006-02-28
Start date
2004-06-30
Completion date
2005-12-31
Last updated
2006-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Ventilator Associated Pneumonia

Keywords

clarithromycin, sepsis, immunomodulation

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.

Detailed description

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.

Interventions

DRUGIntravenous Clarithromycin

Sponsors

University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Days in ICU after diagnosis of VAP
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

Secondary

MeasureTime frame
Influence of administration of clarithromycin on systemic inflammatory response

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026