- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00714402
Procalcitonin Level and Kinetics in Children With Bacterial Infections
May 17, 2011 updated by: Shaare Zedek Medical Center
Procalcitonin Level as a Prognostic Marker and Its' Kinetics in Children With Bacterial Infections
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
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pob 3235
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Jerusalem, Pob 3235, Israel, 91031
- Shaare Zedek Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 days to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
hospitalized patients at date of admission
Description
Inclusion Criteria:
- Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture
- Cellulitis, lobar pneumonia, osteomyelitis,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
a
children with proven of probable invasive bacterial infections
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
time to defervescence
Time Frame: discharge
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discharge
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
length of hospitalization
Time Frame: discharge
|
discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yechiel Schlesinger, MD, Shaare Zedek Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Study Registration Dates
First Submitted
July 9, 2008
First Submitted That Met QC Criteria
July 11, 2008
First Posted (Estimate)
July 14, 2008
Study Record Updates
Last Update Posted (Estimate)
May 18, 2011
Last Update Submitted That Met QC Criteria
May 17, 2011
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Urologic Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Arthritis
- Otorhinolaryngologic Diseases
- Bacterial Infections and Mycoses
- Sepsis
- Ear Diseases
- Skin Diseases, Infectious
- Bone Diseases
- Suppuration
- Otitis
- Bone Diseases, Infectious
- Otitis Media
- Infections
- Communicable Diseases
- Pneumonia
- Cellulitis
- Bacteremia
- Urinary Tract Infections
- Arthritis, Infectious
- Meningitis
- Bacterial Infections
- Osteomyelitis
- Mastoiditis
Other Study ID Numbers
- pct.ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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