Bacterial Transmission SurveillanceBTSNCT02401204
Bacterial Transmission Dynamics Study
An observational study of Bacterial Transmission Surveillance and Neonatal Intensive Care Unit, run by University of Oxford at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Bacterial Transmission Surveillance, Neonatal Intensive Care Unit, Drug Resistance
- What is being tested?
- Longitudinal surveillance study
- How many people
- 97 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: Neonates up to one month old
Who may be able to join
- All neonates admitted to QSNICH NICU
- Parent/legal guardian gives written informed consent
Who cannot join
- There are no exclusion criteria for this study
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Sirikit National Institute of Child Health
Ratchathewi, Bangkok, 10400
About this study
Official title: 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.
Read the 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.
- Being tested
- Longitudinal surveillance study
- Keywords
- Bacterial transmission, Surveillance, Neonatal, Drug Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal surveillance studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Longitudinal surveillance study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.
Measured: During admission in NICU unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Transmission SurveillanceStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Queen Sirikit National Institute of Child Health
- Responsible party
- Sponsor
- Investigators
- Ben Cooper, Dr., Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401204
- Sponsor's protocol ID
- MODEL1402
- Acronym
- BTS
- Status last verified
- Sep 2019
- First submitted
- 24 Mar 2015
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Transmission Surveillance in Neonatal Intensive Care Unit: Transmission Dynamics and Drug Resistance Patterns
- ClinicalTrials.gov ID
- NCT02401204
- Acronym / sponsor ID
- BTS / MODEL1402
- Keywords
- Bacterial transmission, Surveillance, Neonatal, Drug Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Queen Sirikit National Institute of Child Health
- Study start
- Feb 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates admitted to QSNICH NICU | – | Other: Longitudinal surveillance studyAll 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. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates up to one month old
Key inclusion criteria (2 listed)
- All neonates admitted to QSNICH NICU
- Parent/legal guardian gives written informed consent
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal surveillance studyRegular 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. | Other | Neonates admitted to QSNICH NICU |
Primary outcome
Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.
Time frame: During admission in NICU unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Related trials for Bacterial Transmission Surveillance
Active, not recruiting
Improving Implementation of Evidence-based Approaches and Surveillance to Prevent Bacterial Transmission and Infection
Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Cooper, Dr. principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Transmission Surveillance and Neonatal Intensive Care Unit, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonates who acquired infection from each expected pathogens during admission in NICU unit. (time frame: During admission in NICU unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.