NCT01025180

Trial name or title	Study of procalcitonin (procalcitonin)‐guided antibiotic use in severe sepsis patients without obvious infection (Pro‐SEPS)
Methods	RCT
Participants	Inclusion criteria: Hospitalised in resuscitation ward Severe sepsis symptomatology At least 2 SIRS criteria No infectious aetiology detected At least one organ deficiency Exclusion criteria: The presence of a pathogen agent or infectious centre clearly identified Pregnancy Burned Patients with therapeutic limitation Recent surgery Secondary neutropenia
Interventions	Procalcitonin testing for AB guidance
Outcomes	Primary outcome measure: Rate of patients undergoing antibiotic treatment at D5 (time frame: at D5) (designated as safety issue: Yes) Secondary outcome measures: Evolution of the SOFA score between D0, D3 and D5 (time frame: D30) (designated as safety issue: Yes)
Starting date	1 December 2009
Contact information	Djillali Annane: Professor, Co‐ordinator and Principal Investigator
Notes	Quote: "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 multicentre study is a randomised prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotic therapy 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 criterion 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 enrolment is 30 days."