Bacterial InfectionsNCT00714402
Procalcitonin Level and Kinetics in Children With Bacterial Infections
An observational study of Bacterial Infections and Bacteremia, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days to 16 years
- Conditions the study is for
- Bacterial Infections, Bacteremia, Meningitis
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: hospitalized patients at date of admission
Who may be able to join
- Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture
- Cellulitis, lobar pneumonia, osteomyelitis,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Bacterial Infections, Bacteremia, Meningitis, Urinary Tract Infection, Mastoiditis, Lobar Pneumonia
- Keywords
- UTI
- Medical subject headings
- Bacterial Infections, Bacteremia, Meningitis, Urinary Tract Infections, Mastoiditis, Pneumonia, Arthritis, Infectious, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| a | children with proven of probable invasive bacterial infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to defervescence
Measured: discharge
Secondary outcomes (1)
length of hospitalization
Measured: discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yechiel Schlesinger, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714402
- Sponsor's protocol ID
- pct.ctil
- Status last verified
- Jan 2009
- First submitted
- 9 Jul 2008
- Last updated
- 18 May 2011
- Results posted
- No
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. doi: 10.1016/0014-5793(84)80839-x.
PubMed 6546550Assicot 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.
PubMed 8094770Christ-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.
PubMed 16603606Schuetz 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.
PubMed 17615073Nobre 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.
PubMed 18096708Boussekey 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.
PubMed 16477418Seligman 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.
PubMed 16956405Hatherill 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.
PubMed 10921600
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Level as a Prognostic Marker and Its' Kinetics in Children With Bacterial Infections
- ClinicalTrials.gov ID
- NCT00714402
- Acronym / sponsor ID
- pct.ctil
- Conditions
- Bacterial Infections, Bacteremia, Meningitis, Urinary Tract Infection, Mastoiditis, Lobar Pneumonia
- Keywords
- UTI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a | – | –children with proven of probable invasive bacterial infections |
Who may qualify
- Ages
- 3 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- hospitalized patients at date of admission
Key inclusion criteria (2 listed)
- Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture
- Cellulitis, lobar pneumonia, osteomyelitis,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to defervescence
Time frame: discharge
1 secondary outcome
length of hospitalization
Time frame: discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- Background: PubMed 6546550Le 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.
- Background: PubMed 8094770Assicot 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.
- Background: PubMed 16603606Christ-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.
- Background: PubMed 17615073Schuetz 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.
- Background: PubMed 18096708Nobre 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.
- Background: PubMed 16477418Boussekey 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.
- Background: PubMed 16956405Seligman 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.
- Background: PubMed 10921600Hatherill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yechiel Schlesinger, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections and Bacteremia, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to defervescence (time frame: discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00714402, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.