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Clarithromycin as Immunomodulator for the Management of Sepsis

NCT01223690 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2011-08-04

No results posted yet for this study

Summary

The herein protocol is based on the results of one former clinical trial conducted by our study group showing the considerable efficacy of intravenously administered clarithromycin as an adjuvant to antimicrobial chemotherapy for patients with sepsis, septic shock and respiratory failure in the field of ventilator-associated pneumonia. The proposed clinical trial is based on the need to generalize the application of intravenous clarithromycin in the total of admitted septic patients irrespective of the underlying cause of sepsis.

Conditions

  • Sepsis
  • Severe Sepsis
  • Septic Shock

Interventions

DRUG

Clarithromycin

1000 mg diluted into 250 ml of dextrose 5% administered intravenously within one hour of continuous infusion for four consecutive days

DRUG

Dextrose 5%

1000 mg diluted into 250 ml of dextrose 5% administered intravenously within one hour of continuous infusion for four consecutive days

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Evangelos Giamarellos-Bourboulis, MD, PhD · National and Kapodistrian University of Athens

  • Helen Giamarellou, MD, PhD · National and Kapodistrian University of Athens

  • Apostolos Armaganidis, MD · National and Kapodistrian University of Athens

  • George Koratzanis, MD · Sismanogleion Athens General Hospital

  • Charalambos Gogos, MD, PhD · University of Patras

  • Konstantinos Atmatzidis, MD · University of Thessaloniki

  • Emmanouel Douzinas, MD, PhD · National and Kapodistrian University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-11-30
Completion
2011-04-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01223690 on ClinicalTrials.gov