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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 : June 26, 2018
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

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.

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Antibiotic Use Procalcitonin PCT Antimicrobial Resistance AMR Behavioral: PCT group Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
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
Official Title: Procalcitonin Level Guided Cessation of Antibiotic Therapy in Children With Sepsis: A Randomized Controlled Trial
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Arm Intervention/treatment
Experimental: PCT group
PCT group
Behavioral: PCT group
In this group antibiotic therapy will be stopped based on serial PCT measurements starting from admission.

No Intervention: Standard practice group
No intervention



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388944


Contacts
Contact: Jhuma Sankar, MD +911126546784 jhumaji@gmail.com
Contact: Rakesh Lodha +911126593621 rlodha1661@gmail.com

Locations
India
PGIMER Not yet recruiting
Chandigarh, India
Contact: Arun Baranwal, MD       baranwal1970@gmail.com   
Sub-Investigator: Jayashree Muralidharan, DM         
JIPMER Not yet recruiting
Puducherry, India, 605006
Contact: Ramesh Kumar, DM       krramesh_iway@yahoo.co.in   
Sub-Investigator: Mahadevan Subramanian, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Postgraduate Institute of Medical Education and Research
Jawaharlal Institute of Postgraduate Medical Education & Research
Investigators
Study Chair: S K Kabra, MD All India Institute of Medical Sciences, New Delhi

Additional Information:
Responsible Party: Jhuma Sankar, Assistant Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT03388944     History of Changes
Other Study ID Numbers: IEC-531/11.11.2016
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents