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Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection

NCT01025180 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2010-12-06

No results posted yet for this study

Summary

A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.

The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.

This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)

140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.

The primary outcome is the rate of patients undergoing antibiotic treatment at D5.

Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.

Duration of patient enrollment is 30 days.

Conditions

  • Severe Sepsis

Interventions

OTHER

Procalcitonin level

The duration of antibiotic treatment is based on PCT level: * \< 0.25 ng/ml: antibiotic should be stopped * 0.25 \< PCT \<0.5: antibiotic prescription is not recommended * \> 0.5 ng/ml: antibiotic should be used

Sponsors & Collaborators

  • Brahms France

    lead INDUSTRY

Principal Investigators

  • Djillali Annane, Professor · Raymond Poincaré hospital Garches-France

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-01-31
Completion
2010-03-31

Countries

  • France

Study Locations

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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 NCT01025180 on ClinicalTrials.gov