NCT01025180

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

Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Brahms France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-01-01
• Completion: 2010-03-01
• First posted: 2009-12-03
• Last updated: 2010-12-06

Locations

9 sites across 1 country: France