Bacterial Transmission Dynamics Study

NCT ID: NCT02401204

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-05-31

Brief Summary

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.

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.

Conditions

Bacterial Transmission Surveillance; Neonatal Intensive Care Unit; Drug Resistance

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Longitudinal surveillance study

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol Oxford Tropical Medicine Research Unit

OTHER

Sponsor Role: collaborator

Queen Sirikit National Institute of Child Health

OTHER_GOV

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ben Cooper, Dr.

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, Thailand

Countries

Thailand

Other Identifiers

MODEL1402

Identifier Type: -

Identifier Source: org_study_id