The clinical features, antimicrobial susceptibility patterns and genomics of bacteria causing neonatal sepsis in a children’s hospital in Vietnam

The clinical features, antimicrobial susceptibility patterns and genomics of bacteria causing neonatal sepsis in a children’s hospital in Vietnam: an observational prospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN69124914

Enrollment

800

Registered

2017-06-06

Start date

2017-01-02

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal sepsis Neonatal Diseases Bacterial sepsis of newborn

Interventions

An observational prospective study to characterize the clinical features of neonates with sepsis, the microbial population structure, antimicrobial susceptibility patterns and the antimicrobial resist

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Neonates (=1 month of age) 2. Diagnosis of probable sepsis or confirmed sepsis 3. Have blood culture taken 4. Inpatient at local hospital between 2017 and 2018 5. Informed consent given by parents or guardians

Exclusion criteria

Exclusion criteria: Informed consent not given

Design outcomes

Primary

Measure	Time frame
1. Clinical characteristics of neonates with sepsis, recorded on a case report form during hospital stay from admission to discharge 2. The etiology of neonatal sepsis and the distribution of pathogens by clinical departments, assessed using the blood culture results including the isolation and identification information recorded on a case report form during hospital stay from admission to discharge 3. Antimicrobial susceptibility and resistance of isolated bacteria, assessed using disc testing, minimum inhibitory concentrations, conventional PCR and genome sequencing of resistance genes, during hospital stay from admission to discharge 4. The impact of specific bacteria and antimicrobial resistance profile on patient outcomes (mortality, length of stay and cost of treatment), recorded on a case report form during hospital stay at day 7, day 14, day 21 and day 28 after admission and at discharge 5. Genome sequence profile of isolated bacteria, assessed using Illumina whole genome sequencing at the end of recruitment	—

Measure

Time frame

1. Clinical characteristics of neonates with sepsis, recorded on a case report form during hospital stay from admission to discharge 2. The etiology of neonatal sepsis and the distribution of pathogens by clinical departments, assessed using the blood culture results including the isolation and identification information recorded on a case report form during hospital stay from admission to discharge 3. Antimicrobial susceptibility and resistance of isolated bacteria, assessed using disc testing, minimum inhibitory concentrations, conventional PCR and genome sequencing of resistance genes, during hospital stay from admission to discharge 4. The impact of specific bacteria and antimicrobial resistance profile on patient outcomes (mortality, length of stay and cost of treatment), recorded on a case report form during hospital stay at day 7, day 14, day 21 and day 28 after admission and at discharge 5. Genome sequence profile of isolated bacteria, assessed using Illumina whole genome sequencing at the end of recruitment

—

Secondary

Measure	Time frame
1. Antimicrobial resistance profile and gene distribution of the isolated bacteria by clinical departments, assessed using disc testing, minimum inhibitory concentrations, conventional PCR and genome sequencing of resistance genes, at the end of recruitment 2. The population structure of the isolated bacteria, the antimicrobial resistance gene pool and other horizontally transferred DNA, assessed by genome sequencing at the end of recruitment	—

Measure

Time frame

1. Antimicrobial resistance profile and gene distribution of the isolated bacteria by clinical departments, assessed using disc testing, minimum inhibitory concentrations, conventional PCR and genome sequencing of resistance genes, at the end of recruitment 2. The population structure of the isolated bacteria, the antimicrobial resistance gene pool and other horizontally transferred DNA, assessed by genome sequencing at the end of recruitment

—

Countries

Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026