Infant, NewbornPhase 3NCT03280147
7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis
A Phase 3 study testing 7-day course of antibiotics and 14-day course of antibiotics in people with Infant, Newborn and Neonatal SEPSIS, run by Indian Council of Medical Research at 7 sites in India.
Trial summary
The optimum duration of intravenous antibiotic therapy for culture-proven neonatal bacterial sepsis is not known. Current practices, ranging from 7 days to 14 days of antibiotics, are not evidence-based. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Infant, Newborn, Neonatal SEPSIS, Anti-bacterial Agents
- What is being tested?
- 7-day course of antibiotics and 14-day course of antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 7 sitesIndia
- Study dates
- 1 Jan 2019to 31 Jan 2023
- Phase
- Phase 3
- 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 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inclusion criteria for the initial observation part of study preceding randomization
- Neonates aged 0-28 days, either inborn or outborn, who are currently admitted in the Neonatal Unit of the centre.
- Whose birth weight is greater than or equal to1000 grams (it should be reliably ascertained from records of a hospital)
- Whose residence is within approximately 15 kms from the center, so that the infant can be brought back to the center for follow-up
- Who have suspected septicemia for which a conventional or BACTEC/BACTALERT blood culture is sent and for which the treating physician decides to start antibiotics
- Inclusion criteria for Randomization applicable after 7 days of therapy of above patients with sensitive antibiotics:
- Positive blood culture other than Staphylococcus aureus
- No signs and symptoms of sepsis from end of day 5 through end of day 7 of starting sensitive antibiotics
Who cannot join
- Exclusion criteria for the initial observation part of study preceding randomization:
- Central Nervous System infection (Central Nervous System infection (meningitis will be defined as CSF Cells >25 per uL with polys >60% OR [(CSF glucose <20 mg/dL OR CSF:blood* glu ratio <0.6) AND (CSF protein >150 mg/dL in term OR >180 mg/dL in preterm)]
- Septic arthritis, osteomyelitis or deep-seated abscess as clinically judged by the treating team
- Life threatening congenital malformations as judged by the principal investigator of the centre
- Exclusion criteria for randomization applicable after 7 days of therapy of above patients with sensitive antibiotics:
- Sterile blood culture
Show all 12Show fewer
- Suspected contaminants in blood culture.
- Growth of Staphylococcus aureus in blood culture
- Growth of fungal organism in blood culture
- Diagnosis of meningitis, septic arthritis, osteomyelitis, abscess
- Has not gone into remission on day 5 or have recurrence of symptoms from day 5 through day 7
- If the empiric antibiotic is resistant but neonate has shown improvement of signs and symptoms of sepsis and there is ambiguity regarding in vivo sensitivity of antibiotic use
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Indira Gandhi Institute of Child Health
Bangalore, Karnataka, 560029
Postgraduate Institute of Medical Education and Research
Chandigarh, 160023
Madras Medical College (for Institute of Obstetrics and Gynaecology)
Chennai, Tamil Nadu, 600008
King Georges Medical University
Lucknow, Uttar Pradesh, 226003
Kalawati Saran Childrens Hospital and Lady Hardinge Medical College
New Delhi, 110001
Chacha Nehru Bal Chikitsalaya
New Delhi, 110031
Pandit BD Sharma Postgraduate Institute of Medical Sciences
Rohtak, Haryana, 124001
About this study
Official title: Comparison of the Efficacy of a 7-day Versus 14-day Course of Intravenous Antibiotics in the Treatment of Uncomplicated Neonatal Bacterial Sepsis: a Randomized Controlled Non-inferiority Trial
The optimum duration of intravenous antibiotic therapy for culture-proven neonatal bacterial sepsis is not known. Current practices, ranging from 7 days to 14 days of antibiotics, are not evidence-based. This is a randomized, active -controlled, multi-centric, non-inferiority trial to compare the efficacy of a 7-day course of intravenous antibiotics versus a 14-day course among neonates weighing > 1000 g at birth with culture-proven bacterial sepsis that is uncomplicated by meningitis, bone or joint infections deep-seated abscesses. The primary outcome measure is a definite or probable relapse within 21 days after stoppage of antibiotics.
Read the detailed description
The optimum duration of intravenous antibiotic therapy for uncomplicated neonatal bacterial septicemia is not known. Pediatricians administer anywhere between 7 to 14 days of antibiotics, but these practices are not evidence based. C reactive protein (CRP) guided antibiotic duration is based on limited data and serial quantitative CRP is both cumbersome and not universally available. If it could be demonstrated that a 7-day course of antibiotics is not inferior to a 14-day course of antibiotics in terms of relapse rates of infection, then a 7 day course of antibiotics could be uniformly adopted, resulting in economic savings, shorter duration of hospitalization, less chances of hospital acquired infections, less chances of antibiotic induced adverse events and less antibiotic resistance. To test this hypothesis, a randomized, active-controlled, multi-centric, non-inferiority trial to compare the efficacy of a 7-day course of intravenous antibiotics with a 14-day course has been planned. Subjects weighing more than 1000 g at birth with suspected sepsis will be enrolled and observed for a 7-day period to see if they meet eligibility criteria for randomization. Subjects will be randomized on the 7th day of antibiotics, if the initial blood culture grows a non-Staphylococcus aureus bacterial organism, if they have no meningitis, osteomyelitis, septic arthritis or deep seated abscess and if the sepsis goes into clinical remission by the 5th day and remains in remission up to the 7th day of sensitive antibiotics. Subjects in the 14-day group will receive 7 more days of antibiotics after randomization, whereas those in the 7-day group will receive no further antibiotics after randomization. Subjects will be followed up for a 35-day period after randomization. The key outcome will be treatment failure as measured by "definite or probable relapse" within a 21-day period after completion of antibiotic therapy. Secondary outcomes will include definite relapse within 21 and 28 days after antibiotic completion and within 28 and 35 days after randomization; and probable relapse at similar time points. Other secondary outcomes will include secondary infections and adverse events. A total sample size of 700 (350 in each arm) will be required to detect a non-inferiority margin of 7%, assumed event rate of 10%, with 90% power, one-sided alpha error of 5% and loss to follow-up of approximately 10%. Data safety monitoring board will monitor serious adverse events in the trial and will perform at 1/3rd and 2/3rd of expected recruitment. At the time of interim analysis, the DSMB will revisit the sample size of the study. O'Brien Fleming's stopping criteria will be used for the primary outcome while Pocock's stopping rule will be used for the serious adverse events.
- Conditions
- Infant, Newborn, Neonatal SEPSIS, Anti-bacterial Agents, Recurrence
- Being tested
- 7-day course of antibiotics, 14-day course of antibiotics
- Keywords
- Neonate, Sepsis, Antibiotics, Duration
- Medical subject headings
- Neonatal Sepsis, Recurrence, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day course of antibioticsDrug
Subjects in the "7-day course of antibiotics" arm of the study will receive no further antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization. The choice of antibiotics would be guided by the blood culture and sensitivity report. Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports. Hence, names of specific antibiotics and/or their brand names have not been mentioned.
14-day course of antibioticsDrug
Subjects in the "14-day course of antibiotics" arm of the study will receive 7 more days of antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization. The choice of antibiotics would be guided by the blood culture and sensitivity report. Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports. Hence, names of specific antibiotics and/or their brand names have not been mentioned.
| Study group | Role | What they receive |
|---|---|---|
| 7-day course of antibiotics | Experimental | Randomization of subjects will be performed at the end of 7 days of sensitive intravenous antibiotic administration, provided the subjects meet randomization criteria. Those who are randomized to the 7-day group will not receive any further antibiotics. Receives: Drug: 7-day course of antibiotics |
| 14-day course of antibiotics | Active comparator | Randomization of subjects will be performed at the end of 7 days of sensitive intravenous antibiotic administration, provided the subjects meet randomization criteria. Those who are randomized to the 14-day group will receive 7 more days of the same antibiotics, to make it a total of 14 days. Receives: Drug: 14-day course of antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definite or probable relapse within 21 days post-antibiotic completion as per protocol
Among participants who adhered to study protocol- Definite relapse: Episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode, Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-21 days after the end of the planned antibiotic therapy
Definite or probable relapse within 21 days post-antibiotic completion as per intention to treat
Among all randomized patients- Definite relapse: Episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode, Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-21 days after the end of the planned antibiotic therapy
Secondary outcomes (22)
Definite relapse within 21 days post-antibiotic completion, as per protocol
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
Measured: From 0-21 days after the end of the planned antibiotic therapy
Definite relapse within 21 days post-antibiotic completion, as per intention-to-treat
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
Measured: From 0-21 days after the end of the planned antibiotic therapy
Definite relapse within 28 days post-antibiotic completion, as per protocol
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
Measured: From 0-28 days after the end of the planned antibiotic therapy
Definite relapse within 28 days post-antibiotic completion, as per intention-to-treat
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
Measured: From 0-28 days after the end of the planned antibiotic therapy
Definite relapse within 28 days post-randomization, as per protocol
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
Measured: From 0-28 days after randomization
Definite relapse within 28 days post-randomization, as per Intention-to-treat
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
Measured: From 0-28 days after randomization
Definite relapse within 35 days post-randomization, as per protocol
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
Measured: From 0-35 days after randomization
Definite relapse within 35 days post-randomization, as per intention to treat
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
Measured: From 0-35 days after randomization
Probable relapse within 21 days post-antibiotic completion, as per protocol
Among participants who adhered to study protocol Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-21 days after the end of the planned antibiotic therapy
Probable relapse within 21 days post-antibiotic completion, as per intention-to-treat
Among all randomized patients Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-21 days after the end of the planned antibiotic therapy
Probable relapse within 28 days post-antibiotic completion, as per protocol
Among participants who adhered to study protocol Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-28 days after the end of the planned antibiotic therapy
Probable relapse within 28 days post-antibiotic completion, as per intention-to-treat
Among all randomized patients Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-28 days after the end of the planned antibiotic therapy
Probable relapse within 28 days post-randomization, as per protocol
Among participants who adhered to study protocol Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-28 days after randomization
Probable relapse within 28 days post-randomization, as per intention-to-treat
Among all randomized patients Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-28 days after randomization
Probable relapse within 35 days post-randomization, as per protocol
Among participants who adhered to study protocol Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-35 days after randomization
Probable relapse within 35 days post-randomization, as per intention-to-treat
Among all randomised patients Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-35 days after randomization
Definite relapse or probable relapse within 28 days post-randomization, as per protocol
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-28 days after randomization
Definite relapse or probable relapse within 28 days post-randomization, as per Intention-to-treat
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-28 days after randomization
Definite relapse or probable relapse within 35 days post-randomization, as per protocol
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-35 days after randomization
Definite relapse or probable relapse within 35 days post-randomization, as per intention-to-treat
Among all randomised patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Measured: From 0-35 days after randomization
Secondary sepsis
Sepsis due to bacterial organisms other than the original etiologic bacteria or with a different antibiogram or with a fungal organism
Measured: From 0-35 days after randomization
Adverse events
Adverse events as per a list of adverse events, graded as per severity, and defined a priori
Measured: From 0-35 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jan 2019
- Primary completion30 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, outcome-assessor blinded, active-controlled, multi-centric, non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Council of Medical Research
- Sponsor type
- Other government
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, Chacha Nehru Bal Chikitsalaya, New Delhi, Lady Hardinge Medical College, Indira Gandhi Institute of Child Health, Bangalore, Institute of Obstetrics and Gynecology, Chennai, King George's Medical University, Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, St Johns Medical College Hospital, Bangalore, India
- Responsible party
- Principal investigator, Sourabh Dutta, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Sourabh Dutta, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280147
- Sponsor's protocol ID
- 5/7/329/2009-RHN
- Status last verified
- Oct 2023
- First submitted
- 9 Sep 2017
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dutta S, Nangia S, Jajoo M, Sundaram M, Kumar M, Shivanna N, Gathwala G, Nesargi S, Jain S, Kumar P, Saili A, Karthik A, Tripathi S, Bandiya P, Dalal P, Ray P, Randhawa VS, Saigal K, Radhakrishnan D, Venkatesh V, Jagannatha B, Sharma M, Nagaraj S, Malik M, Dogra S, Mittal S, Saini A, Makkar N, Dhir M, Chandramohan A, Pragati RA, Srivastava T, Mukundan L, Benakappa N, Shukla A, Rasaily R. Seven-day versus 14-day antibiotic course for culture-proven neonatal sepsis: a multicentre randomised non-inferiority trial in a low and middle-income country. Arch Dis Child Fetal Neonatal Ed. 2025 Oct 17;110(6):586-594. doi: 10.1136/archdischild-2024-328232.
PubMed 40280737
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of a 7-day Versus 14-day Course of Intravenous Antibiotics in the Treatment of Uncomplicated Neonatal Bacterial Sepsis: a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03280147
- Acronym / sponsor ID
- 5/7/329/2009-RHN
- Conditions
- Infant, Newborn, Neonatal SEPSIS, Anti-bacterial Agents, Recurrence
- Keywords
- Neonate, Sepsis, Antibiotics, Duration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Indian Council of Medical ResearchOther government
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh, Chacha Nehru Bal Chikitsalaya, New Delhi, Lady Hardinge Medical College, Indira Gandhi Institute of Child Health, Bangalore, Institute of Obstetrics and Gynecology, Chennai, King George's Medical University, Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, St Johns Medical College Hospital, Bangalore, India
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 12 Sep 2017 (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 optimum duration of intravenous antibiotic therapy for culture-proven neonatal bacterial sepsis is not known. Current practices, ranging from 7 days to 14 days of antibiotics, are not evidence-based. This is a randomized, active -controlled, multi-centric, non-inferiority trial to compare the efficacy of a 7-day course of intravenous antibiotics versus a 14-day course among neonates weighing > 1000 g at birth with culture-proven bacterial sepsis that is uncomplicated by meningitis, bone or joint infections deep-seated abscesses. The primary outcome measure is a definite or probable relapse within 21 days after stoppage of antibiotics.
Detailed description
The optimum duration of intravenous antibiotic therapy for uncomplicated neonatal bacterial septicemia is not known. Pediatricians administer anywhere between 7 to 14 days of antibiotics, but these practices are not evidence based. C reactive protein (CRP) guided antibiotic duration is based on limited data and serial quantitative CRP is both cumbersome and not universally available. If it could be demonstrated that a 7-day course of antibiotics is not inferior to a 14-day course of antibiotics in terms of relapse rates of infection, then a 7 day course of antibiotics could be uniformly adopted, resulting in economic savings, shorter duration of hospitalization, less chances of hospital acquired infections, less chances of antibiotic induced adverse events and less antibiotic resistance. To test this hypothesis, a randomized, active-controlled, multi-centric, non-inferiority trial to compare the efficacy of a 7-day course of intravenous antibiotics with a 14-day course has been planned. Subjects weighing more than 1000 g at birth with suspected sepsis will be enrolled and observed for a 7-day period to see if they meet eligibility criteria for randomization. Subjects will be randomized on the 7th day of antibiotics, if the initial blood culture grows a non-Staphylococcus aureus bacterial organism, if they have no meningitis, osteomyelitis, septic arthritis or deep seated abscess and if the sepsis goes into clinical remission by the 5th day and remains in remission up to the 7th day of sensitive antibiotics. Subjects in the 14-day group will receive 7 more days of antibiotics after randomization, whereas those in the 7-day group will receive no further antibiotics after randomization. Subjects will be followed up for a 35-day period after randomization. The key outcome will be treatment failure as measured by "definite or probable relapse" within a 21-day period after completion of antibiotic therapy. Secondary outcomes will include definite relapse within 21 and 28 days after antibiotic completion and within 28 and 35 days after randomization; and probable relapse at similar time points. Other secondary outcomes will include secondary infections and adverse events. A total sample size of 700 (350 in each arm) will be required to detect a non-inferiority margin of 7%, assumed event rate of 10%, with 90% power, one-sided alpha error of 5% and loss to follow-up of approximately 10%. Data safety monitoring board will monitor serious adverse events in the trial and will perform at 1/3rd and 2/3rd of expected recruitment. At the time of interim analysis, the DSMB will revisit the sample size of the study. O'Brien Fleming's stopping criteria will be used for the primary outcome while Pocock's stopping rule will be used for the serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, outcome-assessor blinded, active-controlled, multi-centric, non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| 7-day course of antibiotics | Experimental | Drug: 7-day course of antibioticsRandomization of subjects will be performed at the end of 7 days of sensitive intravenous antibiotic administration, provided the subjects meet randomization criteria. Those who are randomized to the 7-day group will not receive any further antibiotics. |
| 14-day course of antibiotics | Active comparator | Drug: 14-day course of antibioticsRandomization of subjects will be performed at the end of 7 days of sensitive intravenous antibiotic administration, provided the subjects meet randomization criteria. Those who are randomized to the 14-day group will receive 7 more days of the same antibiotics, to make it a total of 14 days. |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Inclusion criteria for the initial observation part of study preceding randomization
- Neonates aged 0-28 days, either inborn or outborn, who are currently admitted in the Neonatal Unit of the centre.
- Whose birth weight is greater than or equal to1000 grams (it should be reliably ascertained from records of a hospital)
- Whose residence is within approximately 15 kms from the center, so that the infant can be brought back to the center for follow-up
- Who have suspected septicemia for which a conventional or BACTEC/BACTALERT blood culture is sent and for which the treating physician decides to start antibiotics
Key exclusion criteria (12 listed)
- Central Nervous System infection (Central Nervous System infection (meningitis will be defined as CSF Cells >25 per uL with polys >60% OR [(CSF glucose <20 mg/dL OR CSF:blood* glu ratio <0.6) AND (CSF protein >150 mg/dL in term OR >180 mg/dL in preterm)]
- Septic arthritis, osteomyelitis or deep-seated abscess as clinically judged by the treating team
- Life threatening congenital malformations as judged by the principal investigator of the centre
- Exclusion criteria for randomization applicable after 7 days of therapy of above patients with sensitive antibiotics:
- Sterile blood culture
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 |
|---|---|---|
| 7-day course of antibioticsSubjects in the "7-day course of antibiotics" arm of the study will receive no further antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization. The choice of antibiotics would be guided by the blood culture and sensitivity report. Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports. Hence, names of specific antibiotics and/or their brand names have not been mentioned. | Drug | 7-day course of antibiotics |
| 14-day course of antibioticsSubjects in the "14-day course of antibiotics" arm of the study will receive 7 more days of antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization. The choice of antibiotics would be guided by the blood culture and sensitivity report. Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports. Hence, names of specific antibiotics and/or their brand names have not been mentioned. | Drug | 14-day course of antibiotics |
Primary outcome
Definite or probable relapse within 21 days post-antibiotic completion as per protocol
Time frame: From 0-21 days after the end of the planned antibiotic therapy
Among participants who adhered to study protocol- Definite relapse: Episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode, Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
Definite or probable relapse within 21 days post-antibiotic completion as per intention to treat
Time frame: From 0-21 days after the end of the planned antibiotic therapy
Among all randomized patients- Definite relapse: Episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode, Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
22 secondary outcomes
Definite relapse within 21 days post-antibiotic completion, as per protocol
Time frame: From 0-21 days after the end of the planned antibiotic therapy
Definite relapse within 21 days post-antibiotic completion, as per intention-to-treat
Time frame: From 0-21 days after the end of the planned antibiotic therapy
Definite relapse within 28 days post-antibiotic completion, as per protocol
Time frame: From 0-28 days after the end of the planned antibiotic therapy
Definite relapse within 28 days post-antibiotic completion, as per intention-to-treat
Time frame: From 0-28 days after the end of the planned antibiotic therapy
Definite relapse within 28 days post-randomization, as per protocol
Time frame: From 0-28 days after randomization
Definite relapse within 28 days post-randomization, as per Intention-to-treat
Time frame: From 0-28 days after randomization
Definite relapse within 35 days post-randomization, as per protocol
Time frame: From 0-35 days after randomization
Definite relapse within 35 days post-randomization, as per intention to treat
Time frame: From 0-35 days after randomization
Probable relapse within 21 days post-antibiotic completion, as per protocol
Time frame: From 0-21 days after the end of the planned antibiotic therapy
Probable relapse within 21 days post-antibiotic completion, as per intention-to-treat
Time frame: From 0-21 days after the end of the planned antibiotic therapy
Probable relapse within 28 days post-antibiotic completion, as per protocol
Time frame: From 0-28 days after the end of the planned antibiotic therapy
Probable relapse within 28 days post-antibiotic completion, as per intention-to-treat
Time frame: From 0-28 days after the end of the planned antibiotic therapy
Probable relapse within 28 days post-randomization, as per protocol
Time frame: From 0-28 days after randomization
Probable relapse within 28 days post-randomization, as per intention-to-treat
Time frame: From 0-28 days after randomization
Probable relapse within 35 days post-randomization, as per protocol
Time frame: From 0-35 days after randomization
Probable relapse within 35 days post-randomization, as per intention-to-treat
Time frame: From 0-35 days after randomization
Definite relapse or probable relapse within 28 days post-randomization, as per protocol
Time frame: From 0-28 days after randomization
Definite relapse or probable relapse within 28 days post-randomization, as per Intention-to-treat
Time frame: From 0-28 days after randomization
Definite relapse or probable relapse within 35 days post-randomization, as per protocol
Time frame: From 0-35 days after randomization
Definite relapse or probable relapse within 35 days post-randomization, as per intention-to-treat
Time frame: From 0-35 days after randomization
Secondary sepsis
Time frame: From 0-35 days after randomization
Adverse events
Time frame: From 0-35 days after randomization
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 2 Nov 2023.
- Derived from this study: PubMed 40280737Dutta S, Nangia S, Jajoo M, Sundaram M, Kumar M, Shivanna N, Gathwala G, Nesargi S, Jain S, Kumar P, Saili A, Karthik A, Tripathi S, Bandiya P, Dalal P, Ray P, Randhawa VS, Saigal K, Radhakrishnan D, Venkatesh V, Jagannatha B, Sharma M, Nagaraj S, Malik M, Dogra S, Mittal S, Saini A, Makkar N, Dhir M, Chandramohan A, Pragati RA, Srivastava T, Mukundan L, Benakappa N, Shukla A, Rasaily R. Seven-day versus 14-day antibiotic course for culture-proven neonatal sepsis: a multicentre randomised non-inferiority trial in a low and middle-income country. Arch Dis Child Fetal Neonatal Ed. 2025 Oct 17;110(6):586-594. doi: 10.1136/archdischild-2024-328232.
- 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.
Sourabh Dutta principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7-day course of antibiotics and 14-day course of antibiotics in people with Infant, Newborn and Neonatal SEPSIS, run by Indian Council of Medical Research at 7 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 8 inclusion and 12 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 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Definite or probable relapse within 21 days post-antibiotic completion as per protocol (time frame: From 0-21 days after the end of the planned antibiotic therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280147, which also lists 1 linked publication.
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 2 Nov 2023.