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Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

R

Rijnstate Hospital

Status

Withdrawn

Conditions

Intensive Care
Sepsis

Treatments

Other: Procalcitonin measurement

Study type

Interventional

Funder types

Other

Identifiers

NCT00987818
630-190809

Details and patient eligibility

About

The adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the ICU based on inflammatory markers has not been extensively studied.

Procalcitonin (PCT) is an acute phase protein that has prognostic value in critically ill patients and can be used to monitor disease activity in sepsis and systemic inflammation. This study will examine the effect of PCT guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the ICU.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients admitted to the ICU
  • Age > 18 years
  • Antibiotic therapy for sepsis with a suspected or proven focus of infection

Exclusion criteria

  • Age < 18 years
  • Pregnancy
  • Infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, Pneumocystis jiroveci pneumonia, Toxoplasmosis, Legionellosis, Listeriosis)
  • Indication for prolonged systemic prophylactic antibiotic therapy
  • Severe viral or parasitic infections (hemorrhagic fever, malaria)
  • Antibiotic therapy started 48 hours before enrollment
  • Severe immunocompromised patients (AIDS with a CD4 count < 200cells/mm3, severe neutropenia(<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation)
  • Patients foregoing life sustaining treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

0 participants in 2 patient groups, including a placebo group

PCT guided antibiotic therapy
Experimental group
Treatment:
Other: Procalcitonin measurement
Standard antibiotic therapy
Placebo Comparator group
Treatment:
Other: Procalcitonin measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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