NCT01652404

Brief 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_3 sepsis

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3 sepsis

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

August 22, 2011

Last Update Submit

July 27, 2012

Conditions

Sepsis

Keywords

ICUsepsisantibiotic therapyprocalcitonin

Outcome Measures

Primary Outcomes (2)

  • Average antibiotics duration

    Efficacy endpoint

    28 days

  • 28-day mortality rate

    Safety endpoint

    28 days

Secondary Outcomes (7)

  • Proportion of antibiotics use in both arms

    28 days

  • Length of ICU stay

    90 days

  • Recurrence of fever within 72 hours of antibiotics discontinuation

    28 days

  • SOFA score (Sequential Organ Failure Assessment score)

    28 days

  • Reinfection rate between 72-hours and 28 days post antibiotics discontinuation

    28 days

  • +2 more secondary outcomes

Study Arms (2)

Procalcitonin-guided treatment

EXPERIMENTAL

The duration of antibiotics will be determined by the procalcitonin levels.

Behavioral: Procalcitonin-guided treatment

Conventional treatment

ACTIVE COMPARATOR

The duration of antibiotics will be determined by the treating physician.

Behavioral: Conventional treatment

Interventions

Procalcitonin-guided treatmentBEHAVIORAL

The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.

Procalcitonin-guided treatment
Conventional treatmentBEHAVIORAL

The antibiotics duration will be determined by treating physician.

Conventional treatment

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \* 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
  • 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)

You may not qualify if:

  • 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
  • Bacterial meningitis
  • Osteomyelitis
  • Infective endocarditis
  • Local abscess
  • Mediastinitin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Children's Hospital

Changsha, Hunan, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 12535494BACKGROUND

  • Lee 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.

    PMID: 21034941BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chien-Chang Lee, MD, MSc

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Yi-Min Zhu, BSc

    Hunan Children's Hospital

    STUDY CHAIR

Central Study Contacts

Chien-Chang Lee, MD, MSc

CONTACT

886972651951cclee100@gmail.com

Yi-Min Zhu, BSc

CONTACT

073185356850csvzhuyimin@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

July 30, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

CN(1)