Clinical trial NCT00714402: Procalcitonin Level and Kinetics in Children With Bacterial Infections
Official title: Procalcitonin Level as a Prognostic Marker and Its' Kinetics in Children With Bacterial Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Bacteremia
Meningitis
Urinary Tract Infection
Mastoiditis
Lobar Pneumonia
Septic Arthritis
Cellulitis
Osteomyelitis
Keywords: UTI
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients at date of admission

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture
* Cellulitis, lobar pneumonia, osteomyelitis,

Primary outcomes:
measure: time to defervescence
timeFrame: discharge
Secondary outcomes:
measure: length of hospitalization
timeFrame: discharge
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Pob 3235
Study officials:
affiliation: Shaare Zedek Medical Center
name: Yechiel Schlesinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/0014-5793(84)80839-x.
citation: 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. doi: 10.1016/0140-6736(93)90277-n.
citation: 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. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.
citation: Schuetz P, Christ-Crain M, Wolbers M, Schild U, Thomann R, Falconnier C, Widmer I, Neidert S, Blum CA, Schonenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Muller 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. doi: 10.1186/1472-6963-7-102.
citation: 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. doi: 10.1164/rccm.200708-1238OC. Epub 2007 Dec 20.
citation: 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. doi: 10.1007/s00134-005-0047-8. Epub 2006 Feb 14.
citation: 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. doi: 10.1186/cc5036.
citation: 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. doi: 10.1097/00003246-200007000-00068.