Procalcitonin Level and Kinetics in Children With Bacterial Infections

This study is not yet open for participant recruitment.

Verified by Shaare Zedek Medical Center, July 2008

First Received: July 9, 2008 Last Updated: July 11, 2008 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:

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
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:	Case-Only, Prospective
Official Title:	Procalcitonin Level as a Prognostic Marker and Its' Kinetics in Children With Bacterial Infections

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Cellulitis Meningitis Pneumonia Urinary Tract Infections

Drug Information available for: Procalcitonin

U.S. FDA Resources

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

Biospecimen Description:

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

Contacts

Contact: Yechiel Schlesinger, Dr	97226555147	s.yechiel@gmail.com
Contact: Orli Megged, Dr	97226666340	orlimegged@yahoo.com

Locations

Israel, POB 3235
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:	Shaare Zedek Medical Center ( Yechiel Schlesinger )
Study ID Numbers:	pct.ctil
Study First Received:	July 9, 2008
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00714402 History of Changes
Health Authority:	Israel: Helsinki committee

Keywords provided by Shaare Zedek Medical Center:

UTI

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Urinary Tract Infections
Arthritis, Infectious
Infection
Bone Diseases
Ear Diseases
Meningitis
Gram-Positive Bacterial Infections
Cellulitis
Pathologic Processes
Urologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Musculoskeletal Diseases

Streptococcal Infections
Pneumonia, Bacterial
Arthritis
Connective Tissue Diseases
Suppuration
Mastoiditis
Systemic Inflammatory Response Syndrome
Otorhinolaryngologic Diseases
Joint Diseases
Nervous System Diseases
Pneumonia, Pneumococcal
Otitis Media
Central Nervous System Diseases
Bacteremia
Pneumococcal Infections

ClinicalTrials.gov processed this record on November 30, 2009