Bacterial Transmission Dynamics Study

NCT02401204 | Completed

• 1 other identifier: MODEL1402
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Transmission Surveillance; Neonatal Intensive Care Unit; Drug Resistance

Keywords

Bacterial transmission; Surveillance; Neonatal; Drug Resistance

Outcome Measures

Primary Outcomes (1)

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

  During admission in NICU unit

Study Arms (1)

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

Interventions

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.

Neonates admitted to QSNICH NICU

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates up to one month old

You may qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• Queen Sirikit National Institute of Child Health: collaborator

Study Sites (1)

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, 10400, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool Tracheal suction swab Rectal swab

Study Officials

• Ben Cooper, Dr.

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

TH (1)