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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01025180
Acronym
Pro-SEPS
Enrollment
62
Registered
2009-12-03
Start date
2007-12-31
Completion date
2010-03-31
Last updated
2010-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis

Keywords

safety, Procalcitonin, PCT, SOFA, Sepsis, Antibiotic, Strategy, SIRS, severe sepsis without obvious infection

Brief 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.

Interventions

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

Brahms France
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* hospitalized in resuscitation ward * severe sepsis symptomatology * at least 2 SIRS criteria * no infectious etiology 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

Design outcomes

Primary

MeasureTime frame
rate of patients undergoing antibiotic treatment at D5.at D5

Secondary

MeasureTime frame
evolution of the SOFA score between D0, D3 and D5.D30

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026