Neonatal SEPSISNCT03721302
NeoAMR Observational Study in Neonatal Sepsis
An observational study of Neonatal SEPSIS, run by Drugs for Neglected Diseases at 19 sites in 11 countries.
Trial summary
Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and… Read more about this study
- Who is it for?
- Ages Up to 60 days
- Conditions the study is for
- Neonatal SEPSIS
- What is being tested?
- Main study clinical sepsis and Microbiology sub study
- How many people
- 3,202 participants
- Where
- 19 sitesin 11 countries
- Study dates
- 16 Aug 2018to 29 Feb 2020
- Phase
- Observational
- 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 Up to 60 days
- All sexes
- No healthy volunteers
- Child
Study population: Hospitalized Babies with significant sepsis
Who may be able to join
- In-patient in the hospital (NNU (Neonatal unit) or paediatric ward) of one of the partner institutions
- Age <60 days of age
- Clinical suspicion of a new episode of sepsis (as defined below)** together with planned treatment with IV antibiotics OR new episode of confirmed bacterial meningitis^ OR new episode of infection in which a Carbapenem-resistant organism (CRO) is isolated from blood culture OR new episode of infection in which a candida species is isolated from blood culture
- Informed consent from parent / guardian
- Willingness to provide location information and to be contacted at 28 days from start of antibiotic treatment
Who cannot join
- • Previously enrolled in this study, unless readmitted and re-started on antibiotics before the 28 day follow-up limit is reached
- Enrollment in any interventional trial
- A serious, non-infective co-morbidity (other than prematurity), anticipated to cause death within 72 hours
Trial locations and contacts
19 sites in 11 countries.
19 sites in 11 countries
China3 sites
Beijing Children Hospital
Beijing
Beijing Obstetrics and Gynecology Hospital
Beijing
Shenzhen Children Hospital
Shenzhen
India3 sites
King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College
Mumbai
Lady Hardinge Medical College
New Delhi
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry
South Africa3 sites
Tygerberg Hospital
Cape Town
Charlotte Maxeke
Johannesburg
Chris Hani Baragwanath Academic Hospital
Johannesburg
Brazil2 sites
FCM da Santa Casa de São Paulo
São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
São Paulo
Thailand2 sites
Queen Sirikit National Institute of Child Health
Bangkok
Chiang Rai Prachanukroh Hospital
Chiang Rai
About this study
Official title: A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.
Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and culture-positive).
Read the detailed description
- NeoSEPSIS: Consecutive hospitalized babies with neonatal sepsis will be recruited and followed up until discharge from hospital or death (for a maximum of 28 days). A minimal neonatal sepsis dataset will determine (i) clinical presentations, associated features and risk factors (for example prematurity, SGA (small for gestational age)), (ii) rates of culture-positivity among babies with sepsis, (iii) current empirical treatment approaches (antimicrobials selected, dose, etc) (iv) outcomes of sepsis, including death, need for intensive care interventions and recurrence of sepsis during the follow-up period. Microbiological samples will be taken from sterile sites, blood and CSF, as clinically indicated and will be processed locally.
- NeoBSI: Consecutive babies with positive blood/CSF cultures and sepsis will be recruited. Patient inclusion will be based on identification of relevant specified bacteria from blood / CSF cultures. In addition to the data collected for NeoSEPSIS, information will be collected on the isolates and their antimicrobial susceptibility patterns.
- Conditions
- Neonatal SEPSIS
- Being tested
- Main study clinical sepsis, Microbiology sub study
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Main study clinical sepsisOther
No intervention-Observational study
Microbiology sub studyOther
Analysis of Bacterial isolates
| Study group | Role | What they receive |
|---|---|---|
| Main Study Clinical Sepsis | Clinical and Antimicrobial Assessments Receives: Other: Main study clinical sepsis | |
| Microbiology Sub study | Clinical and Antimicrobial Assessments Receives: Other: Main study clinical sepsis; Other: Microbiology sub study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
To estimate mortality rates in hospitalised infants less than 60 days of age who are being treated for significant sepsis (where significant is defined as presenting with 2 or more of the signs /symptoms listed in the inclusion criteria).
Measured: 28 days
Secondary outcomes (1)
To determine the microbiological epidemiology, including antimicrobial susceptibility and resistance mechanisms, in infants with positive blood and/or cerebrospinal fluid culture
The incidence of culture positive and culture negative sepsis (both bloodstream and CSF isolates)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start16 Aug 2018
- Primary completion31 Dec 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- St George's, University of London, PENTA Foundation, Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Mike Sharland, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721302
- Sponsor's protocol ID
- NeoOBS 001
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Folgori L, Ellis SJ, Bielicki JA, Heath PT, Sharland M, Balasegaram M. Tackling antimicrobial resistance in neonatal sepsis. Lancet Glob Health. 2017 Nov;5(11):e1066-e1068. doi: 10.1016/S2214-109X(17)30362-5. No abstract available.
PubMed 29025624Russell NJ, Stohr W, Plakkal N, Cook A, Berkley JA, Adhisivam B, Agarwal R, Ahmed NU, Balasegaram M, Ballot D, Bekker A, Berezin EN, Bilardi D, Boonkasidecha S, Carvalheiro CG, Chami N, Chaurasia S, Chiurchiu S, Colas VRF, Cousens S, Cressey TR, de Assis ACD, Dien TM, Ding Y, Dung NT, Dong H, Dramowski A, Ds M, Dudeja A, Feng J, Glupczynski Y, Goel S, Goossens H, Hao DTH, Khan MI, Huertas TM, Islam MS, Jarovsky D, Khavessian N, Khorana M, Kontou A, Kostyanev T, Laoyookhon P, Lochindarat S, Larsson M, Luca M, Malhotra-Kumar S, Mondal N, Mundhra N, Musoke P, Mussi-Pinhata MM, Nanavati R, Nakwa F, Nangia S, Nankunda J, Nardone A, Nyaoke B, Obiero CW, Owor M, Ping W, Preedisripipat K, Qazi S, Qi L, Ramdin T, Riddell A, Romani L, Roysuwan P, Saggers R, Roilides E, Saha SK, Sarafidis K, Tusubira V, Thomas R, Velaphi S, Vilken T, Wang X, Wang Y, Yang Y, Zunjie L, Ellis S, Bielicki JA, Walker AS, Heath PT, Sharland M. Patterns of antibiotic use, pathogens, and prediction of mortality in hospitalized neonates and young infants with sepsis: A global neonatal sepsis observational cohort study (NeoOBS). PLoS Med. 2023 Jun 8;20(6):e1004179. doi: 10.1371/journal.pmed.1004179. eCollection 2023 Jun.
PubMed 37289666
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.
- ClinicalTrials.gov ID
- NCT03721302
- Acronym / sponsor ID
- NeoOBS 001
- Conditions
- Neonatal SEPSIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,202 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- St George's, University of London, PENTA Foundation, Universiteit Antwerpen
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 26 Oct 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.
Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and culture-positive).
Detailed description
- NeoSEPSIS: Consecutive hospitalized babies with neonatal sepsis will be recruited and followed up until discharge from hospital or death (for a maximum of 28 days). A minimal neonatal sepsis dataset will determine (i) clinical presentations, associated features and risk factors (for example prematurity, SGA (small for gestational age)), (ii) rates of culture-positivity among babies with sepsis, (iii) current empirical treatment approaches (antimicrobials selected, dose, etc) (iv) outcomes of sepsis, including death, need for intensive care interventions and recurrence of sepsis during the follow-up period. Microbiological samples will be taken from sterile sites, blood and CSF, as clinically indicated and will be processed locally.
- NeoBSI: Consecutive babies with positive blood/CSF cultures and sepsis will be recruited. Patient inclusion will be based on identification of relevant specified bacteria from blood / CSF cultures. In addition to the data collected for NeoSEPSIS, information will be collected on the isolates and their antimicrobial susceptibility patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main Study Clinical Sepsis | – | Other: Main study clinical sepsisClinical and Antimicrobial Assessments |
| Microbiology Sub study | – | Other: Main study clinical sepsis, Other: Microbiology sub studyClinical and Antimicrobial Assessments |
Who may qualify
- Ages
- Up to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospitalized Babies with significant sepsis
Key inclusion criteria (5 listed)
- In-patient in the hospital (NNU (Neonatal unit) or paediatric ward) of one of the partner institutions
Key exclusion criteria (3 listed)
- • Previously enrolled in this study, unless readmitted and re-started on antibiotics before the 28 day follow-up limit is reached
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 |
|---|---|---|
| Main study clinical sepsisNo intervention-Observational study | Other | Main Study Clinical Sepsis, Microbiology Sub study |
| Microbiology sub studyAnalysis of Bacterial isolates | Other | Microbiology Sub study |
Primary outcome
Mortality Rate
Time frame: 28 days
To estimate mortality rates in hospitalised infants less than 60 days of age who are being treated for significant sepsis (where significant is defined as presenting with 2 or more of the signs /symptoms listed in the inclusion criteria).
1 secondary outcome
To determine the microbiological epidemiology, including antimicrobial susceptibility and resistance mechanisms, in infants with positive blood and/or cerebrospinal fluid culture
Time frame: 28 days
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 19 Aug 2020.
- Background: PubMed 29025624Folgori L, Ellis SJ, Bielicki JA, Heath PT, Sharland M, Balasegaram M. Tackling antimicrobial resistance in neonatal sepsis. Lancet Glob Health. 2017 Nov;5(11):e1066-e1068. doi: 10.1016/S2214-109X(17)30362-5. No abstract available.
- Derived from this study: PubMed 37289666Russell NJ, Stohr W, Plakkal N, Cook A, Berkley JA, Adhisivam B, Agarwal R, Ahmed NU, Balasegaram M, Ballot D, Bekker A, Berezin EN, Bilardi D, Boonkasidecha S, Carvalheiro CG, Chami N, Chaurasia S, Chiurchiu S, Colas VRF, Cousens S, Cressey TR, de Assis ACD, Dien TM, Ding Y, Dung NT, Dong H, Dramowski A, Ds M, Dudeja A, Feng J, Glupczynski Y, Goel S, Goossens H, Hao DTH, Khan MI, Huertas TM, Islam MS, Jarovsky D, Khavessian N, Khorana M, Kontou A, Kostyanev T, Laoyookhon P, Lochindarat S, Larsson M, Luca M, Malhotra-Kumar S, Mondal N, Mundhra N, Musoke P, Mussi-Pinhata MM, Nanavati R, Nakwa F, Nangia S, Nankunda J, Nardone A, Nyaoke B, Obiero CW, Owor M, Ping W, Preedisripipat K, Qazi S, Qi L, Ramdin T, Riddell A, Romani L, Roysuwan P, Saggers R, Roilides E, Saha SK, Sarafidis K, Tusubira V, Thomas R, Velaphi S, Vilken T, Wang X, Wang Y, Yang Y, Zunjie L, Ellis S, Bielicki JA, Walker AS, Heath PT, Sharland M. Patterns of antibiotic use, pathogens, and prediction of mortality in hospitalized neonates and young infants with sepsis: A global neonatal sepsis observational cohort study (NeoOBS). PLoS Med. 2023 Jun 8;20(6):e1004179. doi: 10.1371/journal.pmed.1004179. eCollection 2023 Jun.
- Individual participant dataSharing planned: Undecided
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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.
Mike Sharland principal investigator
St George's, University of London
19 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal SEPSIS, run by Drugs for Neglected Diseases at 19 sites in 11 countries.
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 5 inclusion and 3 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China, India, South Africa, Brazil, Thailand and 6 more countries. 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?
Mortality Rate (time frame: 28 days). 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 NCT03721302, which also lists 2 linked publications.
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 19 Aug 2020.