Bacterial Transmission Dynamics Study

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.

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Key information

Conditions

Bacterial Transmission Surveillance Drug Resistance Neonatal Intensive Care Unit

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Longitudinal surveillance study

Other

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.

Primary outcomes

Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.

Time frame: During admission in NICU unit

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

Mahidol Oxford Tropical Medicine Research Unit
Queen Sirikit National Institute of Child Health

Registry information

Official study title

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

Acronym: BTS

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Mar 27, 2015
Registry last updated: Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed