Infant Newborn DiseaseInfGNMDR-NeoNCT04812847
Multidrug Resistant Gram-negative Pathogen Infections in High Risk Neonates in the Northeast of Mexico
An observational study of Infant Newborn Disease, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
Trial summary
The main objective of this project is to establish a prospective cohort to measure the Gram-negative infection burden in neonates under special care in a regional referral hospital, and to characterize all microorganisms isolates from these subjects at the phenotype and genotype level, specifically in relation to the… Read more about this study
- Who is it for?
- Ages 1 day to 180 days
- Conditions the study is for
- Infant Newborn Disease
- What is being tested?
- Identification of MDR characteristics
- How many people
- 597 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2021to 31 Dec 2022
- 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 1 day to 180 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates, both at term and preterm, of any gestational age, under special care in the Neonatology Division of a tertiary care regional perinatal center in the Northeast of Mexico.
Who may be able to join
- Neonates of either sex, and any gestational age, admitted to the special care nursery of Hospital Regional Materno Infantil (Includes also out-born and transferred babies),
- Treating physician´s order to draw any biological sample and send it for culture at the hospital´s clinical laboratory.
- A culture with an isolate of Gram-negative bacteria.
Who cannot join
- Any culture negative for bacterial growth
- Any culture with Gram-positive bacteria, or fungus growth.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional Materno Infantil de Alta Especialidad, Secretaría de Salud
Guadalupe, Nuevo León, 67140
About this study
Official title: Infecciones Por patógenos Gramnegativos Con Multirresistencia a Drogas en Neonatos de Alto Riesgo en el Noreste de México
The main objective of this project is to establish a prospective cohort to measure the Gram-negative infection burden in neonates under special care in a regional referral hospital, and to characterize all microorganisms isolates from these subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates).
Read the detailed description
The investigators propose a mixed design approach, a cohort´s study with a nested case-control analysis. Study subjects will be the gram-negative isolates at the study hospital clinical laboratory. The cohort´s exposure factor will be the presence or absence of a multidrug resistance gram-negative bacterial isolate.
The prospective cohort will allow the estimation of Gram-negative infection burden in the study population, and the characterization of all microorganisms isolates from study subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates); the cohort will be formed by each neonate, from the admission to special care, the isolation date and then follow-up until the resolution, being it discharge either alive, dead or by transfer to another facility. Risk ratios for each of these outcomes will be calculated.
Cases-controls analysis will allow the research team to identify main risk factors present in those individuals who further had or did not have a gram-negative MDR isolate, by calculation of associated odds ratios for concurrent perinatal factors. Another project goal, to establish correlations and measure risk factors (Odds ratios) between Gram-negative infection with MDR organisms and concurrent illness and treatments offered in the special care nursery (medical [antibiotics, non-steroid anti-inflammatory drugs, steroids, others], surgical, and clinical procedures) in neonates under special care, will also be attained through the nested cases and controls study approach.
Finally, a derivative from this project will be the establishment of the North-East Mexico Regional Repository of bacterial isolates in Neonates under special care. At the first stage, this repository will preserve specimens of bacteria, both Gram-negative and Gram-positive, along with a specially developed anonymous database of the individuals hosting those infections. In the near future, the focus of this repository may expand to fungus, parasites and perhaps viral isolates preservation.
The research team has also proposed an exploratory objective, subject to budget availability, and that is the characterization and comparison of the immuno-phenotype of those individuals affected of Gram-negative infection with MDR resistant organisms, those with infection with other organisms and those not affected by infectious complications.
All gram-negative isolates will be probed for the gene expression of 38 selected antibiotic resistance loci, and 96 selected samples will be further studied by next generation sequentiation.
- Conditions
- Infant Newborn Disease
- Being tested
- Identification of MDR characteristics
- Keywords
- Drug Resistance, Multiple, Bacterial.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of MDR characteristicsDiagnostic test
Identification of MDR in culture media, followed by amplification of related genes from the bacterial isolates
| Study group | Role | What they receive |
|---|---|---|
| Gram negative infection, MDR present | Neonates with one or more gram-negative bacterial isolates with MDR characteristics during their clinical course in the Neonatal Intensive Care Unit of the study hospital. Receives: Diagnostic Test: Identification of MDR characteristics | |
| Gram negative infection, MDR absent | Neonates with one or more gram-negative bacterial isolates with no MDR characteristics during their clinical course in the Neonatal Intensive Care Unit of the study hospital. Receives: Diagnostic Test: Identification of MDR characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of Gram Negative organisms infections
The isolation of a gram-negative organism, from any clinical site, in neonates under clinical care in special care nursery; Incidence = New cases during the study period, Prevalence = Total cases during the study period.
Measured: Through study completion, an average of three months
Secondary outcomes (2)
Odds ratio for the occurrence of Gram-negative MDR infections
To identify and measure the Odds-ratio for the occurrence of Gram-negative infection with MDR resistant organisms and all concurrent perinatal factors. This will be done through a nested case and controls study approach.
Measured: Through study completion, an average of three months
Risk factors for the occurrence of Gram-negative MDR infections.
To establish correlations and measure risk factors (Relative risks) between Gram-negative infection with MDR organisms and concurrent illness and treatments offered in the special care nursery (medical [antibiotics, non-steroid anti-inflammatory drugs, steroids, others], surgical, and clinical procedures) in neonates under special care. This will be attained with a cohorts study approach.
Measured: Through study completion, an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Newborn DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Javier Lara-Diaz, M.D., Ph.D., Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Victor Javier Lara-Diaz, MD, PhD, Study chair, Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la SaludCuauhtémoc Licona-Cassani, PhD, Principal investigator, Tecnológico de Monterrey, Centro de Biotecnología FEMSAMarion Genevieve Brunck, PhD, Principal investigator, Tecnológico de Monterrey, Escuela de Ingeniería y Ciencias, GIEE on Translational Omics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812847
- Sponsor's protocol ID
- InfGNMDR-Neo
- Acronym
- InfGNMDR-Neo
- Status last verified
- Feb 2023
- First submitted
- 10 Mar 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Initially, we plan to share raw data with qualified researchers and entities worldwide, but we have not yet decided a specific repository.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infecciones Por patógenos Gramnegativos Con Multirresistencia a Drogas en Neonatos de Alto Riesgo en el Noreste de México
- ClinicalTrials.gov ID
- NCT04812847
- Acronym / sponsor ID
- InfGNMDR-Neo / InfGNMDR-Neo
- Conditions
- Infant Newborn Disease
- Keywords
- Drug Resistance, Multiple, Bacterial.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- 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.
The main objective of this project is to establish a prospective cohort to measure the Gram-negative infection burden in neonates under special care in a regional referral hospital, and to characterize all microorganisms isolates from these subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates).
Detailed description
The investigators propose a mixed design approach, a cohort´s study with a nested case-control analysis. Study subjects will be the gram-negative isolates at the study hospital clinical laboratory. The cohort´s exposure factor will be the presence or absence of a multidrug resistance gram-negative bacterial isolate.
The prospective cohort will allow the estimation of Gram-negative infection burden in the study population, and the characterization of all microorganisms isolates from study subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates); the cohort will be formed by each neonate, from the admission to special care, the isolation date and then follow-up until the resolution, being it discharge either alive, dead or by transfer to another facility. Risk ratios for each of these outcomes will be calculated.
Cases-controls analysis will allow the research team to identify main risk factors present in those individuals who further had or did not have a gram-negative MDR isolate, by calculation of associated odds ratios for concurrent perinatal factors. Another project goal, to establish correlations and measure risk factors (Odds ratios) between Gram-negative infection with MDR organisms and concurrent illness and treatments offered in the special care nursery (medical [antibiotics, non-steroid anti-inflammatory drugs, steroids, others], surgical, and clinical procedures) in neonates under special care, will also be attained through the nested cases and controls study approach.
Finally, a derivative from this project will be the establishment of the North-East Mexico Regional Repository of bacterial isolates in Neonates under special care. At the first stage, this repository will preserve specimens of bacteria, both Gram-negative and Gram-positive, along with a specially developed anonymous database of the individuals hosting those infections. In the near future, the focus of this repository may expand to fungus, parasites and perhaps viral isolates preservation.
The research team has also proposed an exploratory objective, subject to budget availability, and that is the characterization and comparison of the immuno-phenotype of those individuals affected of Gram-negative infection with MDR resistant organisms, those with infection with other organisms and those not affected by infectious complications.
All gram-negative isolates will be probed for the gene expression of 38 selected antibiotic resistance loci, and 96 selected samples will be further studied by next generation sequentiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gram negative infection, MDR present | – | Diagnostic Test: Identification of MDR characteristicsNeonates with one or more gram-negative bacterial isolates with MDR characteristics during their clinical course in the Neonatal Intensive Care Unit of the study hospital. |
| Gram negative infection, MDR absent | – | Diagnostic Test: Identification of MDR characteristicsNeonates with one or more gram-negative bacterial isolates with no MDR characteristics during their clinical course in the Neonatal Intensive Care Unit of the study hospital. |
Who may qualify
- Ages
- 1 day to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates, both at term and preterm, of any gestational age, under special care in the Neonatology Division of a tertiary care regional perinatal center in the Northeast of Mexico.
Key inclusion criteria (3 listed)
- Neonates of either sex, and any gestational age, admitted to the special care nursery of Hospital Regional Materno Infantil (Includes also out-born and transferred babies),
- Treating physician´s order to draw any biological sample and send it for culture at the hospital´s clinical laboratory.
- A culture with an isolate of Gram-negative bacteria.
Key exclusion criteria (2 listed)
- Any culture negative for bacterial growth
- Any culture with Gram-positive bacteria, or fungus growth.
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 |
|---|---|---|
| Identification of MDR characteristicsIdentification of MDR in culture media, followed by amplification of related genes from the bacterial isolates | Diagnostic test | Gram negative infection, MDR absent, Gram negative infection, MDR present |
Primary outcome
Burden of Gram Negative organisms infections
Time frame: Through study completion, an average of three months
The isolation of a gram-negative organism, from any clinical site, in neonates under clinical care in special care nursery; Incidence = New cases during the study period, Prevalence = Total cases during the study period.
2 secondary outcomes
Odds ratio for the occurrence of Gram-negative MDR infections
Time frame: Through study completion, an average of three months
Risk factors for the occurrence of Gram-negative MDR infections.
Time frame: Through study completion, an average of three months
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 1 Mar 2023.
- Individual participant dataSharing planned: Undecided. Initially, we plan to share raw data with qualified researchers and entities worldwide, but we have not yet decided a specific repository.
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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.
Victor Javier Lara-Diaz, MD, PhD study chair
Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud
Cuauhtémoc Licona-Cassani, PhD principal investigator
Tecnológico de Monterrey, Centro de Biotecnología FEMSA
Marion Genevieve Brunck, PhD principal investigator
Tecnológico de Monterrey, Escuela de Ingeniería y Ciencias, GIEE on Translational Omics
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 Infant Newborn Disease, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
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 3 inclusion and 2 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 1 Mar 2023. 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 Mexico. 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?
Burden of Gram Negative organisms infections (time frame: Through study completion, an average of three months). 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 1 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.