Early-Onset Neonatal SepsisNCT06197269
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
A study testing Short duration antibiotics and Standard duration antibiotics in people with Early-Onset Neonatal Sepsis and Antibiotic Stewardship, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis. Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Early-Onset Neonatal Sepsis, Antibiotic Stewardship
- What is being tested?
- Short duration antibiotics and Standard duration antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 15 Apr 2022to 14 Apr 2024
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All Preterm neonates (Gestational age >28weeks and >1000grams)
- age less than 72hours of life
- Started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture
- Symptoms resolved at time of randomization
Who cannot join
- Antibiotics started based on risk factors
- Infants with major congenital anomalies or syndromes.
- Presence of site specific infections including meningitis, pneumonia
- Neonates suspected to have inborn errors of metabolism
- Neonates with Severe birth asphyxia, (Apgar score at 5min <4 and cord Ph< 7.0,base excess <-16)
- Neonates underwent major surgery in 1st week of life
- Deemed by Doctor in charge to be sick enough to be continued on antibiotics
Trial locations and contacts
1 site in 1 country.
India1 site
Lady Hardinge Medical college
New Delhi, National Capital Territory of Delhi, 110001
About this study
Official title: Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis.
Read the detailed description
Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)
Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics
Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.
- Being tested
- Short duration antibiotics, Standard duration antibiotics
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short duration antibioticsOther
antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment
Standard duration antibioticsOther
Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.
| Study group | Role | What they receive |
|---|---|---|
| Short duration antibiotic | Experimental | antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment Receives: Other: Short duration antibiotics |
| Standard duration antibiotic | Active comparator | Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment. Receives: Other: Standard duration antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 'Treatment Failure'
New onset appearance of clinical signs and symptoms requiring initiation of antibiotics
Measured: 15 days of stopping antibiotics
Secondary outcomes (3)
Mortality
Death due to any reason
Measured: Till 1 month of life
Need for additional courses of antibiotic therapy
Additional courses during the study time frame
Measured: Till 1 month of life
Length of hospital stay
Duration of hospital stay
Measured: From date of birth until date of death or discharge whichever come assessed till 1 month of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start15 Apr 2022
- Primary completion14 Feb 2024
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Onset Neonatal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sushma Nangia, M.D., Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197269
- Sponsor's protocol ID
- LHMC/IEC/2019/41
- Status last verified
- Aug 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06197269
- Acronym / sponsor ID
- LHMC/IEC/2019/41
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 9 Jan 2024 (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.
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis.
Detailed description
Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)
Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics
Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short duration antibiotic | Experimental | Other: Short duration antibioticsantibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment |
| Standard duration antibiotic | Active comparator | Other: Standard duration antibioticsAntibiotics will be continued for 5-7 days more, 72 hrs after starting treatment. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All Preterm neonates (Gestational age >28weeks and >1000grams)
- age less than 72hours of life
- Started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture
- Symptoms resolved at time of randomization
Key exclusion criteria (7 listed)
- Antibiotics started based on risk factors
- Infants with major congenital anomalies or syndromes.
- Presence of site specific infections including meningitis, pneumonia
- Neonates suspected to have inborn errors of metabolism
- Neonates with Severe birth asphyxia, (Apgar score at 5min <4 and cord Ph< 7.0,base excess <-16)
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 |
|---|---|---|
| Short duration antibioticsantibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment | Other | Short duration antibiotic |
| Standard duration antibioticsAntibiotics will be continued for 5-7 days more, 72 hrs after starting treatment. | Other | Standard duration antibiotic |
Primary outcome
Incidence of 'Treatment Failure'
Time frame: 15 days of stopping antibiotics
New onset appearance of clinical signs and symptoms requiring initiation of antibiotics
3 secondary outcomes
Mortality
Time frame: Till 1 month of life
Need for additional courses of antibiotic therapy
Time frame: Till 1 month of life
Length of hospital stay
Time frame: From date of birth until date of death or discharge whichever come assessed till 1 month of life
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 13 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short duration antibiotics and Standard duration antibiotics in people with Early-Onset Neonatal Sepsis and Antibiotic Stewardship, run by Lady Hardinge Medical College at 1 site 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 4 inclusion and 7 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of 'Treatment Failure' (time frame: 15 days of 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 13 Aug 2024.