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PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis

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ClinicalTrials.gov Identifier: NCT03388944
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
Postgraduate Institute of Medical Education and Research
Jawaharlal Institute of Postgraduate Medical Education & Research
Information provided by (Responsible Party):
Jhuma Sankar, All India Institute of Medical Sciences, New Delhi

Tracking Information
First Submitted Date  ICMJE August 18, 2017
First Posted Date  ICMJE January 3, 2018
Last Update Posted Date October 18, 2019
Estimated Study Start Date  ICMJE October 21, 2019
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 25, 2017)
Mortality [ Time Frame: Through study completion upto 1 year from the start of the study ]
The primary outcome measure would be mortality and/or treatment failure* (defined as growth of one or more of the initial causative organism(s) from a second sample taken within 48 hours after stopping antibiotics and/ or clinical signs or symptoms of infection) within 7 days of stoppage of antibiotics.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03388944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 25, 2017)
  • Proportion clinically cured [ Time Frame: Through study completion upto 1 year from the start of the study ]
    Proportion clinically cured after the first antibiotic course
  • Duration of antibiotic therapy [ Time Frame: Through study completion upto 1 year from the start of the study ]
    Total number of days the patients are on antibiotics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis
Official Title  ICMJE Procalcitonin Level Guided Cessation of Antibiotic Therapy in Children With Sepsis: A Randomized Controlled Trial
Brief Summary The investigators' objective is to compare the risk of mortality and/or treatment failure in children admitted to the PICU with sepsis and managed by PCT guided therapy for stopping of antibiotics ('study' group) with those managed with 'standard practices' based on the evidence based guidelines ('control' group). Children with suspected or proven sepsis will be randomized to the PCT guided group or the standard practices group and will be followed up for the outcome measures that include treatment failure and mortality. The investigators plan to enroll 650 patients over a period of 3 years. The investigators believe that the proposed study will provide the answer to reducing unnecessary antibiotic usage in the PICU without causing any harm to the patient in the form of treatment failure and/or mortality.
Detailed Description Sepsis and bacterial infections account for more than 50% of and intensive care (ICU) admissions and the mortality rates are as high as 40-60% reported in various studies. Although, antibiotics are crucial in deciding outcomes in children with sepsis, however, use of the same in non-infectious conditions has resulted in emergence of multi drug resistant strains with high morbidity and mortality. The number of deaths from antibiotic resistant bacteria is 700000 worldwide. A major driver for development of multi drug resistant bacteria is antibiotic use. This indiscriminate use is much more pronounced in the ICUs with observations from various studies indicating that 30% to 60% of antibiotics prescribed in ICUs are unnecessary, inappropriate, or suboptimal. This is because of two major reasons a) illness severity and b) difficulty in distinguishing true sepsis from other causes of SIRS. In order to address these problems, researchers have tried to explore the use of novel biomarkers to improve the accuracy, early diagnosis and stopping of antibiotic therapy of sepsis. One such marker that is widely studied is procalcitonin (PCT). Several studies and meta-analyses have demonstrated that PCT has excellent diagnostic accuracy for sepsis and has a potential role in de-escalating antibiotic therapy in adult patients. Unfortunately, there are only few observational studies and two RCT's in children published till date evaluating the use of PCT for diagnosis of infections or de-escalation of antibiotic therapy. Moreover, till date, there are no studies in critically ill children with sepsis who are faced with the problem of multidrug resistant infections and have the worst outcomes. Given this background, the investigators plan to conduct this pragmatic randomized controlled trial in children with sepsis admitted to the Pediatric Intensive Care Unit (PICU) and already on antibiotics. The investigators' objective is to compare the risk of mortality and/or treatment failure in children admitted to the PICU with sepsis and managed by PCT guided therapy for stopping of antibiotics ('study' group) with those managed with 'standard practices' based on the evidence based guidelines ('control' group). Children with suspected or proven sepsis will be randomized to the PCT guided group or the standard practices group and will be followed up for the outcome measures that include treatment failure and mortality. The investigators' would also be comparing the duration and prescription rate of antibiotic therapy between the two groups as secondary outcome measures. The investigators plan to enroll 650 patients over a period of 3 years. The investigators believe that the proposed study will provide the answer to reducing unnecessary antibiotic usage in the PICU without causing any harm to the patient in the form of treatment failure and/or mortality. The investigators also believe that in due course of time, over the years, with restricted antibiotic usage, the issue of multi-drug resistant microbial infections in the PICU will be addressed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Children with suspected or proven sepsis will be randomized to the PCT guided group or the standard practices group and will be followed up for the outcome measures that include treatment failure and mortality. We would also be comparing the duration and prescription rate of antibiotic therapy between the two groups as secondary outcome measures.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Sepsis
  • Septic Shock
  • Antibiotic Use
  • Procalcitonin
  • PCT
  • Antimicrobial Resistance
  • AMR
Intervention  ICMJE Behavioral: PCT group
In this group antibiotic therapy will be stopped based on serial PCT measurements starting from admission.
Study Arms  ICMJE
  • Experimental: PCT group
    PCT group
    Intervention: Behavioral: PCT group
  • No Intervention: Standard practice group
    No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 25, 2017)
650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children 2 month to 17 years admitted to the ICU and already receiving antibiotics for suspected or proven sepsis (defined as systemic inflammatory response syndrome or SIRS due to infection) and children who are started on antibiotics in the ICU for suspected or proven sepsis will be included.

Exclusion Criteria:

  • Children receiving antibiotics more than 24 hours before presentation
  • Children with severe immunosuppression (CD4 count of less than 200 cells/mm3, neutropenic patients (<500 neutrophils/ml)) other than corticosteroid use
  • Children admitted for post-op observation
  • Children with an estimated length of stay less than 24 hrs
  • Children with underlying co-morbidities with possible imminent death
  • Children whose parents refuse to give an informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jhuma Sankar, MD +911126546784 jhumaji@gmail.com
Contact: Rakesh Lodha +911126593621 rlodha1661@gmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03388944
Other Study ID Numbers  ICMJE IEC-531/11.11.2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jhuma Sankar, All India Institute of Medical Sciences, New Delhi
Study Sponsor  ICMJE All India Institute of Medical Sciences, New Delhi
Collaborators  ICMJE
  • Postgraduate Institute of Medical Education and Research
  • Jawaharlal Institute of Postgraduate Medical Education & Research
Investigators  ICMJE
Study Chair: S K Kabra, MD All India Institute of Medical Sciences, New Delhi
PRS Account All India Institute of Medical Sciences, New Delhi
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP