SepsisPhase 3ProShort-PedNCT01652404
PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
A Phase 3 study testing Procalcitonin-guided treatment and Conventional treatment in people with Sepsis, run by Hunan Children's Hospital at 1 site in China.
Trial summary
The purpose of this study is to give conclusive evidence on whether serial PCT (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit). Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Procalcitonin-guided treatment and Conventional treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Dec 2012
- Phase
- Phase 3
- 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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients with laboratory- or image-confirmed severe infection at admission or during stay in pediatric ICU will be eligible for inclusion.
- Definition of laboratory- or image-confirmed severe infection:
- Two or more of four signs of inflammation:
- Temperature >38.3℃ or <36℃
- Heart rate > 90 beats/min
- Respiratory rate >20 breaths/min or PaCO2 (Arterial pressure of carbon dioxide) < 32 mmHg
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- WBC (White Blood Cell count) > 12,000 cells/mm3, <4000 cells/mm3, or >5% band-form WBC
- Initial Procalcitonin > 0.5 ng/mL
- Presence of either laboratory or image evidence of infection
- Laboratory evidence: Sign of inflammation in urine, CSF (Cerebrospinal Fluid), ascites, pleural effusion or local abscess
- Image evidence: Compatible findings on Chest X ray, ultrasound, CT (Computed Tomography), MR image (Magnetic Resonance Image)
Who cannot join
- Age greater than 15 years or less than 1 month
- Known pregnancy
- Expected ICU stay less than 3 days
- Neutropenia: ANC (Absolute Neutrophil Count) <500/mm3
- Specific infections for which long-term antibiotic treatment is strongly recommended:
- Lobar pneumonia or empyema
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- Bacterial meningitis
- Osteomyelitis
- Infective endocarditis
- Local abscess
- Mediastinitin
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Children's Hospital
Changsha, Hunan
Yi-Min Zhu, BSc, 073185386850, csvzhuyimin@163.com
Yi-Min Zhu, BSc
About this study
The purpose of this study is to give conclusive evidence on whether serial PCT (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit).
Read the detailed description
In this study, the investigators aimed to design a multi-center trial addressing aforementioned flaws. The investigators will set stricter inclusion criteria, collect complete data on relapse or secondary infection, and include sufficient number of patients to show non-inferiority to conventional therapy by a delta margin of 10% [11]. The investigators aimed to give conclusive evidence on whether serial PCT measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU.
- Conditions
- Sepsis
- Being tested
- Procalcitonin-guided treatment, Conventional treatment
- Keywords
- ICU, sepsis, antibiotic therapy, procalcitonin
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin-guided treatmentBehavioural
The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
Conventional treatmentBehavioural
The antibiotics duration will be determined by treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonin-guided treatment | Experimental | The duration of antibiotics will be determined by the procalcitonin levels. Receives: Behavioral: Procalcitonin-guided treatment |
| Conventional treatment | Active comparator | The duration of antibiotics will be determined by the treating physician. Receives: Behavioral: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average antibiotics duration
Efficacy endpoint
Measured: 28 days
28-day mortality rate
Safety endpoint
Measured: 28 days
Secondary outcomes (7)
Proportion of antibiotics use in both arms
Efficacy endpoint
Measured: 28 days
Length of ICU stay
Efficacy endpoint
Measured: 90 days
Recurrence of fever within 72 hours of antibiotics discontinuation
Safety endpoint
Measured: 28 days
SOFA score (Sequential Organ Failure Assessment score)
Safety endpoint
Measured: 28 days
Reinfection rate between 72-hours and 28 days post antibiotics discontinuation
Safety endpoint
Measured: 28 days
90-day all-cause mortality
Safety endpoint
Measured: 90 days
90-day readmission rate
Safety endpoint
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Chien-Chang Lee, MD, MSc, Principal investigator, National Taiwan University HospitalYi-Min Zhu, BSc, Study chair, Hunan Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652404
- Sponsor's protocol ID
- HN01
- Acronym
- ProShort-Ped
- Status last verified
- Jul 2012
- First submitted
- 22 Aug 2011
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short versus standard duration oral antibiotic therapy for acute urinary tract infection in children. Cochrane Database Syst Rev. 2003;(1):CD003966. doi: 10.1002/14651858.CD003966.
PubMed 12535494Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038.
PubMed 21034941
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROcalcitonin to SHORTen Antibiotics Duration in PEDiatricICU Patients (ProShort-Ped) Trial
- ClinicalTrials.gov ID
- NCT01652404
- Acronym / sponsor ID
- ProShort-Ped / HN01
- Conditions
- Sepsis
- Keywords
- ICU, sepsis, antibiotic therapy, procalcitonin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hunan Children's HospitalOther government
- Collaborators
- National Taiwan University Hospital
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 30 Jul 2012 (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 purpose of this study is to give conclusive evidence on whether serial PCT (Procalcitonin) measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU (Intensive Care Unit).
Detailed description
In this study, the investigators aimed to design a multi-center trial addressing aforementioned flaws. The investigators will set stricter inclusion criteria, collect complete data on relapse or secondary infection, and include sufficient number of patients to show non-inferiority to conventional therapy by a delta margin of 10% [11]. The investigators aimed to give conclusive evidence on whether serial PCT measurements can facilitate individual decision-making and shorten antibiotic treatment duration in patients with sepsis in the pediatric ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin-guided treatment | Experimental | Behavioral: Procalcitonin-guided treatmentThe duration of antibiotics will be determined by the procalcitonin levels. |
| Conventional treatment | Active comparator | Behavioral: Conventional treatmentThe duration of antibiotics will be determined by the treating physician. |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- All patients with laboratory- or image-confirmed severe infection at admission or during stay in pediatric ICU will be eligible for inclusion.
- Definition of laboratory- or image-confirmed severe infection:
- Two or more of four signs of inflammation:
- Initial Procalcitonin > 0.5 ng/mL
- Presence of either laboratory or image evidence of infection
Key exclusion criteria (11 listed)
- Age greater than 15 years or less than 1 month
- Known pregnancy
- Expected ICU stay less than 3 days
- Neutropenia: ANC (Absolute Neutrophil Count) <500/mm3
- Specific infections for which long-term antibiotic treatment is strongly recommended:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procalcitonin-guided treatmentThe antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9. | Behavioural | Procalcitonin-guided treatment |
| Conventional treatmentThe antibiotics duration will be determined by treating physician. | Behavioural | Conventional treatment |
Primary outcome
Average antibiotics duration
Time frame: 28 days
Efficacy endpoint
28-day mortality rate
Time frame: 28 days
Safety endpoint
7 secondary outcomes
Proportion of antibiotics use in both arms
Time frame: 28 days
Length of ICU stay
Time frame: 90 days
Recurrence of fever within 72 hours of antibiotics discontinuation
Time frame: 28 days
SOFA score (Sequential Organ Failure Assessment score)
Time frame: 28 days
Reinfection rate between 72-hours and 28 days post antibiotics discontinuation
Time frame: 28 days
90-day all-cause mortality
Time frame: 90 days
90-day readmission rate
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- Background: PubMed 12535494Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short versus standard duration oral antibiotic therapy for acute urinary tract infection in children. Cochrane Database Syst Rev. 2003;(1):CD003966. doi: 10.1002/14651858.CD003966.
- Background: PubMed 21034941Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038.
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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.
Chien-Chang Lee, MD, MSc principal investigator
National Taiwan University Hospital
Yi-Min Zhu, BSc study chair
Hunan Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Procalcitonin-guided treatment and Conventional treatment in people with Sepsis, run by Hunan Children's Hospital at 1 site in China.
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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Jul 2012. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Chang Lee, MD, MSc (886972651951, cclee100@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average antibiotics duration (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT01652404, which also lists 2 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 30 Jul 2012.