Bacterial Transmission Dynamics Study (BTS)

Bacterial Transmission Surveillance in Neonatal Intensive Care Unit: Transmission Dynamics and Drug Resistance Patterns

Infections with multiply antibiotic-resistant bacteria represent a major cause of preventable morbidity and mortality amongst hospitalized neonates worldwide. In Southeast Asia, where antibiotic-resistance is a major problem, Gram-negative bacteria account for the majority of such infections. The most common pathogens are Acinetobacter spp., Pseudomonas aeruginosa, Enterobacter spp., Escherichia coli and Klebsiella pneumonia. The great majority of infections with these pathogens represent asymptomatic carriage, though in the absence of routine screening for asymptomatic carriage reliable estimates of the prevalence, rates of transmission between patients, and rates of importation from the community are lacking. Moreover, current understanding of the degree and manner in which different antibiotics act to select for such resistant organisms is rudimentary.

Study Overview

• Status: Completed
• Conditions: Bacterial Transmission Surveillance; Neonatal Intensive Care Unit; Drug Resistance
• Intervention / Treatment: Other: Longitudinal surveillance study

Detailed Description

Objectives: To quantify the prevalence of drug-resistant Gram-negative pathogens on admission to a neonatal intensive care unit and during subsequent days of hospital stay. To quantify rates of patient-to-patient transmission for key organisms, to characterize how patient antibiotic use impacts on the ward-level dynamics of such organisms.

Methods: All infants admitted to the unit over a period of one year for whom the parent/guardian gives informed consent will be included. In addition to routine demographic and clinical data for included patients, full patient-level data on antibiotic use within the ward will also be recorded. Carriage of resistant Gram-negative organisms will be determined though rectal swabs, tracheal aspirates (for ventilated patients) and stool samples taken on admission and at twice weekly intervals. Antibiotic-resistant Gram-negative bacteria will be cultured and their resistant patterns determined. Selected environmental surfaces will also be sampled to detect contamination with such organisms. For the most important organisms (Acinetobacter spp. and Klebsiella spp.) whole genome sequencing will be used in conjunction with Bayesian data augmentation techniques to determine transmission pathways and the impact of antibiotic use on the transmission and persistence of such organisms within the hospital ward.

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Queen Sirikit National Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates up to one month old

Description

Inclusion Criteria:

• All neonates admitted to QSNICH NICU
• Parent/legal guardian gives written informed consent

Exclusion Criteria:

• There are no exclusion criteria for this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neonates admitted to QSNICH NICU; All neonates admitted to the QSNICH NICU over a period of one year from March 2015 to March 2016 meeting the inclusion and exclusion criteria will be enrolled in the study. Readmitted neonates will be eligible to be enrolled again into the study.	Other: Longitudinal surveillance study; Regular specimens will be routinely collected as standard of practice. A rectal swab and stool specimen will be collected twice a week since first admission on NICU until discharge from NICU. If participant is intubated/ventilated, a throat swab will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.	During admission in NICU unit

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Queen Sirikit National Institute of Child Health; Mahidol Oxford Tropical Medicine Research Unit
• Investigators: Principal Investigator: Ben Cooper, Dr., Mahidol Oxford Tropical Medicine Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Surveillance; Neonatal; Drug Resistance; Bacterial transmission
• Other Study ID Numbers: MODEL1402