NeoAMR Observational Study in Neonatal Sepsis

NCT03721302 | Completed DMC

• 1 other identifier: NeoOBS 001
• Study Type: observational
• Target: 3,202
• Locations: 11 countries
• Sites: 19

Brief 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 culture-positive).

Conditions

Neonatal SEPSIS

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  28 days

Study Arms (2)

Main Study Clinical Sepsis

Clinical and Antimicrobial Assessments

Other: Main study clinical sepsis

Microbiology Sub study

Clinical and Antimicrobial Assessments

Other: Main study clinical sepsis; Other: Microbiology sub study

Interventions

Main study clinical sepsis OTHER

No intervention-Observational study

Main Study Clinical Sepsis; Microbiology Sub study

Microbiology sub study OTHER

Analysis of Bacterial isolates

Microbiology Sub study

Eligibility Criteria

• Age: Up to 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized Babies with significant sepsis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead
• St George's, University of London: collaborator
• PENTA Foundation: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (19)

Dhaka Shishu Hospital

Dhaka, Bangladesh

Location

FCM da Santa Casa de São Paulo

São Paulo, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

São Paulo, Brazil

Location

Beijing Children Hospital

Beijing, China

Location

Beijing Obstetrics and Gynecology Hospital

Beijing, China

Location

Shenzhen Children Hospital

Shenzhen, China

Location

Hippokration Hospital

Thessaloniki, Greece

Location

King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College

Mumbai, India

Location

Lady Hardinge Medical College

New Delhi, India

Location

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

Puducherry, India

Location

Bambino Gesu Hospital

Rome, Italy

Location

KEMRI/Wellcome Trust Research Programme

Kilifi, Kenya

Location

Tygerberg Hospital

Cape Town, South Africa

Location

Charlotte Maxeke

Johannesburg, South Africa

Location

Chris Hani Baragwanath Academic Hospital

Johannesburg, South Africa

Location

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

Location

Chiang Rai Prachanukroh Hospital

Chiang Rai, Thailand

Location

Mulago Hospital

Kampala, Uganda

Location

Vietnam National Hospital of Paediatrics

Hanoi, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 29025624 BACKGROUND

• Russell 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.

  PMID: 37289666 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiological isolates

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mike Sharland

  St. George's Hospital, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 26, 2018
• Study Start: August 16, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 29, 2020
• Last Updated: August 19, 2020

Record last verified: 2018-10

Locations

TH (2); IN (3); IT (1); VN (1); CN (3); BA (1); KE (1); UG (1); GR (1); BR (2); ZA (3)