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Procalcitonin Level and Kinetics in Children With Bacterial Infections
This study has been completed.

First Received on July 9, 2008.   Last Updated on May 17, 2011   History of Changes
Sponsor: Shaare Zedek Medical Center
Information provided by: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00714402
  Purpose

The purposes of this study are:

  1. To determine whether procalcitonin level at admission of pediatric patients with bacterial infections can be used as a marker for prediction of defervescence and hospitalization length
  2. To examine the kinetics of procalcitonin in pediatric patients with bacterial infections and persistent fever

Condition
Bacterial Infections
Bacteremia
Meningitis
Urinary Tract Infection
Mastoiditis
Lobar Pneumonia
Septic Arthritis
Cellulitis
Osteomyelitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Procalcitonin Level as a Prognostic Marker and Its' Kinetics in Children With Bacterial Infections

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • time to defervescence [ Time Frame: discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • length of hospitalization [ Time Frame: discharge ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

whole blood


Estimated Enrollment: 50
Study Start Date: August 2008
Groups/Cohorts
a
children with proven of probable invasive bacterial infections

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hospitalized patients at date of admission

Criteria

Inclusion Criteria:

  • Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture
  • Cellulitis, lobar pneumonia, osteomyelitis,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714402

Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Pob 3235, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Yechiel Schlesinger, MD Shaare Zedek Medical Center
  More Information

Publications:
Le Moullec JM, Jullienne A, Chenais J, Lasmoles F, Guliana JM, Milhaud G, Moukhtar MS. The complete sequence of human preprocalcitonin. FEBS Lett. 1984 Feb 13;167(1):93-7.
Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8.
Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin Guidance of Antibiotic Therapy in Community-acquired Pneumonia: A Randomized Trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. Epub 2006 Apr 7.
Schuetz P, Christ-Crain M, Wolbers M, Schild U, Thomann R, Falconnier C, Widmer I, Neidert S, Blum CA, Schönenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Müller B; ProHOSP study group. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial. BMC Health Serv Res. 2007 Jul 5;7:102.
Nobre V, Harbarth S, Graf JD, Rohner P, Pugin J. Use of procalcitonin to shorten antibiotic treatment duration in septic patients: a randomized trial. Am J Respir Crit Care Med. 2008 Mar 1;177(5):498-505. Epub 2007 Dec 20.
Boussekey N, Leroy O, Alfandari S, Devos P, Georges H, Guery B. Procalcitonin kinetics in the prognosis of severe community-acquired pneumonia. Intensive Care Med. 2006 Mar;32(3):469-72. Epub 2006 Feb 14.
Seligman R, Meisner M, Lisboa TC, Hertz FT, Filippin TB, Fachel JM, Teixeira PJ. Decreases in procalcitonin and C-reactive protein are strong predictors of survival in ventilator-associated pneumonia. Crit Care. 2006;10(5):R125.
Hatherill M, Tibby SM, Turner C, Ratnavel N, Murdoch IA. Procalcitonin and cytokine levels: relationship to organ failure and mortality in pediatric septic shock. Crit Care Med. 2000 Jul;28(7):2591-4.

Responsible Party: Yechiel Schlesinger, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00714402     History of Changes
Other Study ID Numbers: pct.ctil
Study First Received: July 9, 2008
Last Updated: May 17, 2011
Health Authority: Israel: Helsinki committee

Keywords provided by Shaare Zedek Medical Center:
UTI

Additional relevant MeSH terms:
Arthritis
Arthritis, Infectious
Bacteremia
Bacterial Infections
Cellulitis
Mastoiditis
Meningitis
Osteomyelitis
Pneumonia
Pneumonia, Pneumococcal
Urinary Tract Infections
Joint Diseases
Musculoskeletal Diseases
Infection
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Skin Diseases, Infectious
Suppuration
Connective Tissue Diseases
Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Bone Diseases, Infectious
Bone Diseases

ClinicalTrials.gov processed this record on February 12, 2012