SepsisNCT03388944
PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis
A study testing PCT group in people with Sepsis and Septic Shock, run by All India Institute of Medical Sciences at 2 sites in India.
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… Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Sepsis, Septic Shock, Antibiotic Use
- What is being tested?
- PCT group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 2 sitesIndia
- Study dates
- 21 Oct 2019to 28 Feb 2023
- Phase
- Interventional
- 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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
India2 sites
St Johns Medical College and Hospital
Bengaluru, Karnataka, 560034
PGIMER
Chandigarh
About this study
Official title: Procalcitonin Level Guided Cessation of Antibiotic Therapy in Children With Sepsis: A Randomized Controlled Trial
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.
Read the 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 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.
- Conditions
- Sepsis, Septic Shock, Antibiotic Use, Procalcitonin, PCT, Antimicrobial Resistance
- Being tested
- PCT group
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT groupBehavioural
In this group antibiotic therapy will be stopped based on serial PCT measurements starting from admission.
| Study group | Role | What they receive |
|---|---|---|
| PCT group | Experimental | PCT group Receives: Behavioral: PCT group |
| Standard practice group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day of stopping first course of antibiotic therapy till day 7 after stopping antibiotics
Secondary outcomes (3)
Proportion clinically cured
Proportion clinically cured after the first antibiotic course
Measured: From day of stopping first course of antibiotic therapy till day 7 of stopping therapy
Antibiotic free days
Total number of days the patients are not on antibiotics
Measured: Till day 28 of hospital stay
Mortality
Death in ICU or hospital
Measured: Till death or day 28 whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start21 Oct 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 primary outcome measure that includes treatment failure. We would also be comparing the duration of antibiotic therapy and mortality between the two groups as secondary outcome measures.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, St Johns Medical College Hospital, Bangalore, India, All India Institute of Medical Sciences, Bhubaneswar
- Responsible party
- Principal investigator, Jhuma Sankar, All India Institute of Medical Sciences
- Investigators
- S K Kabra, MD, Study chair, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388944
- Sponsor's protocol ID
- IEC-531/11.11.2016
- Status last verified
- Feb 2025
- First submitted
- 18 Aug 2017
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Level Guided Cessation of Antibiotic Therapy in Children With Sepsis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03388944
- Acronym / sponsor ID
- IEC-531/11.11.2016
- Conditions
- Sepsis, Septic Shock, Antibiotic Use, Procalcitonin, PCT, Antimicrobial Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, St Johns Medical College Hospital, Bangalore, India, All India Institute of Medical Sciences, Bhubaneswar
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 3 Jan 2018 (actual)
- 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 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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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 primary outcome measure that includes treatment failure. We would also be comparing the duration of antibiotic therapy and mortality between the two groups as secondary outcome measures.
| Arm | Type | Receives |
|---|---|---|
| PCT group | Experimental | Behavioral: PCT groupPCT group |
| Standard practice group | No intervention | –No intervention |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| PCT groupIn this group antibiotic therapy will be stopped based on serial PCT measurements starting from admission. | Behavioural | PCT group |
Primary outcome
Treatment failure
Time frame: From day of stopping first course of antibiotic therapy till day 7 after stopping antibiotics
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.
3 secondary outcomes
Proportion clinically cured
Time frame: From day of stopping first course of antibiotic therapy till day 7 of stopping therapy
Antibiotic free days
Time frame: Till day 28 of hospital stay
Mortality
Time frame: Till death or day 28 whichever is earlier
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Clinical Trials Registry of India - Registered trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
S K Kabra, MD study chair
All India Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCT group in people with Sepsis and Septic Shock, run by All India Institute of Medical Sciences at 2 sites in India.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: From day of stopping first course of antibiotic therapy till day 7 after stopping antibiotics). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025.