Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03388944
Other study ID # IEC-531/11.11.2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2019
Est. completion date February 28, 2023

Study information

Verified date July 2023
Source All India Institute of Medical Sciences, New Delhi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators' objective is to compare the risk of treatment failure* in children admitted to the pediatric intensive care unit (PICU) with sepsis and managed by procalcitonin guided therapy for stopping of antibiotics ('PCT- guided therapy' 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 560 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.


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 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 of antibiotic therapy between the two groups as secondary outcome measures. The investigators plan to enroll 560 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.


Recruitment information / eligibility

Status Completed
Enrollment 561
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Months to 17 Years
Eligibility 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

Study Design


Intervention

Behavioral:
PCT group
In this group antibiotic therapy will be stopped based on serial PCT measurements starting from admission.

Locations

Country Name City State
India St Johns Medical College and Hospital Bengaluru Karnataka
India PGIMER Chandigarh

Sponsors (3)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi Jawaharlal Institute of Postgraduate Medical Education & Research, Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment failure The primary outcome measure would be 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. From day of stopping first course of antibiotic therapy till day 7 after stopping antibiotics
Secondary Proportion clinically cured Proportion clinically cured after the first antibiotic course From day of stopping first course of antibiotic therapy till day 7 of stopping therapy
Secondary Antibiotic free days Total number of days the patients are not on antibiotics Till day 28 of hospital stay
Secondary Mortality Death in ICU or hospital Till death or day 28 whichever is earlier
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3