NCT00714402

Brief Summary

The purposes of this study are:

  1. 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. 2.To examine the kinetics of procalcitonin in pediatric patients with bacterial infections and persistent fever

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
Last Updated

May 18, 2011

Status Verified

January 1, 2009

First QC Date

July 9, 2008

Last Update Submit

May 17, 2011

Conditions

Bacterial InfectionsBacteremiaMeningitisUrinary Tract InfectionMastoiditisLobar PneumoniaSeptic ArthritisCellulitisOsteomyelitis

Keywords

UTI

Outcome Measures

Primary Outcomes (1)

  • time to defervescence

    discharge

Secondary Outcomes (1)

  • length of hospitalization

    discharge

Study Arms (1)

a

children with proven of probable invasive bacterial infections

Eligibility Criteria

Age3 Days - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

hospitalized patients at date of admission

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Pob 3235, 91031, Israel

Location

Related Publications (8)

  • 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.

    PMID: 6546550BACKGROUND

  • 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.

    PMID: 8094770BACKGROUND

  • 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.

    PMID: 16603606BACKGROUND

  • 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.

    PMID: 17615073BACKGROUND

  • 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.

    PMID: 18096708BACKGROUND

  • 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.

    PMID: 16477418BACKGROUND

  • 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.

    PMID: 16956405BACKGROUND

  • 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.

    PMID: 10921600BACKGROUND

Biospecimen

Retention: NONE RETAINED

whole blood

MeSH Terms

Conditions

Bacterial InfectionsBacteremiaMeningitisUrinary Tract InfectionsMastoiditisPneumoniaArthritis, InfectiousCellulitisOsteomyelitis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroinflammatory DiseasesNervous System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBone Diseases, InfectiousBone DiseasesMusculoskeletal DiseasesOtitis MediaOtitisEar DiseasesOtorhinolaryngologic DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesArthritisJoint DiseasesSkin Diseases, InfectiousSuppurationConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yechiel Schlesinger, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 14, 2008

Study Start

August 1, 2008

Last Updated

May 18, 2011

Record last verified: 2009-01

Locations

IL(1)