CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 600 enrolled
Drug / intervention
Clarithromycin +1 moredrug
Likely dose
Clarithromycin 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01223690
NCT01223690Phase 3Completed

A Double-blind Randomized Placebo-controlled Clinical Trial of the Safety and Efficacy of Intravenous Clarithromycin as Immunomodulatory Therapy for the Management of Sepsis

University of Athens·interventional·Posted Oct 19, 2010·Updated Aug 4, 2011

In Brief

A Phase 3 clinical trial evaluating Clarithromycin and Dextrose 5% for Sepsis and 2 related conditions. Completed, enrolled 600 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2010
Enrollment StartJul 1, 2007
Primary CompletionNov 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.7 years ago

Interventions

Clarithromycindrug

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

Dextrose 5%drug

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