NeoAMR Observational Study in Neonatal Sepsis

Neonatal SEPSIS Clinical Trial

Official title:

A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721302
• Other study ID #: NeoOBS 001
• Status: Completed
• Start date: August 16, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: October 2018
• Source: Drugs for Neglected Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 culture-positive).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3202
• Est. completion date: February 29, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal SEPSIS
• Sepsis
• Toxemia

Intervention

Other:
• Main study clinical sepsis
No intervention-Observational study
• Microbiology sub study
Analysis of Bacterial isolates

Locations

Country	Name	City	State
Bangladesh	Dhaka Shishu Hospital	Dhaka
Brazil	FCM da Santa Casa de São Paulo	São Paulo
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto	São Paulo
China	Beijing Children Hospital	Beijing
China	Beijing Obstetrics and Gynecology Hospital	Beijing
China	Shenzhen Children Hospital	Shenzhen
Greece	Hippokration Hospital	Thessaloníki
India	King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College	Mumbai
India	Lady Hardinge Medical College	New Delhi
India	Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)	Pondicherry
Italy	Bambino Gesu Hospital	Rome
Kenya	KEMRI/Wellcome Trust Research Programme	Kilifi
South Africa	Tygerberg Hospital	Cape Town
South Africa	Charlotte Maxeke	Johannesburg
South Africa	Chris Hani Baragwanath Academic Hospital	Johannesburg
Thailand	Queen Sirikit National Institute of Child Health	Bangkok
Thailand	Chiang Rai Prachanukroh Hospital	Chang Rai
Uganda	Mulago Hospital	Kampala
Vietnam	Vietnam National Hospital of Paediatrics	Hanoi

Sponsors (4)

Lead Sponsor	Collaborator
Drugs for Neglected Diseases	PENTA Foundation, St George's, University of London, Universiteit Antwerpen

Countries where clinical trial is conducted

Bangladesh,  Brazil,  China,  Greece,  India,  Italy,  Kenya,  South Africa,  Thailand,  Uganda,  Vietnam, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	28 days