NeoAMR Observational Study in Neonatal Sepsis

Completed

• Conditions: Neonatal SEPSIS
• Interventions: Other: Main study clinical sepsis; Other: Microbiology sub study

• Registration Number: NCT03721302
• Lead Sponsor: Drugs for Neglected Diseases

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).

Detailed Description

1. 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.

2. 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 Timeline

• Study Start: 2018-08-16
• Status Verified: 2018-10
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-26
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-29
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3202

Inclusion Criteria

• 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

Exclusion Criteria

• • 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main Study Clinical Sepsis	Main study clinical sepsis	Clinical and Antimicrobial Assessments
Microbiology Sub study	Microbiology sub study	Clinical and Antimicrobial Assessments
Microbiology Sub study	Main study clinical sepsis	Clinical and Antimicrobial Assessments

Primary Outcome Measures

Name	Time	Method
Mortality Rate	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).

Secondary Outcome Measures

Name	Time	Method
To determine the microbiological epidemiology, including antimicrobial susceptibility and resistance mechanisms, in infants with positive blood and/or cerebrospinal fluid culture	28 days	The incidence of culture positive and culture negative sepsis (both bloodstream and CSF isolates)

Trial Locations

Locations (19)

Lady Hardinge Medical College; 🇮🇳 New Delhi, India

Mulago Hospital; 🇺🇬 Kampala, Uganda

Dhaka Shishu Hospital; 🇧🇩 Dhaka, Bangladesh

FCM da Santa Casa de São Paulo; 🇧🇷 São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; 🇧🇷 São Paulo, Brazil

Beijing Children Hospital; 🇨🇳 Beijing, China

Shenzhen Children Hospital; 🇨🇳 Shenzhen, China

Hippokration Hospital; 🇬🇷 Thessaloníki, Greece

King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College; 🇮🇳 Mumbai, India

Bambino Gesu Hospital; 🇮🇹 Rome, Italy

Beijing Obstetrics and Gynecology Hospital; 🇨🇳 Beijing, China

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER); 🇮🇳 Pondicherry, India

Chiang Rai Prachanukroh Hospital; 🇹🇭 Chang Rai, Thailand

Vietnam National Hospital of Paediatrics; 🇻🇳 Hanoi, Vietnam

KEMRI/Wellcome Trust Research Programme; 🇰🇪 Kilifi, Kenya

Chris Hani Baragwanath Academic Hospital; 🇿🇦 Johannesburg, South Africa

Tygerberg Hospital; 🇿🇦 Cape Town, South Africa

Charlotte Maxeke; 🇿🇦 Johannesburg, South Africa

Queen Sirikit National Institute of Child Health; 🇹🇭 Bangkok, Thailand