Increased Drug ResistanceNCT06044272
Antimicrobial Resistance in Hospitals From Meta, Colombia
An observational study of Increased Drug Resistance, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
Trial summary
Introduction: Healthcare-associated infections cause a burden in morbidity and mortality, and they increase the financial cost of care. Nevertheless, they are not limited to setting factors, and several community conditions and contexts are linked. Read more about this study
- Who is it for?
- Ages Up to 130 years
- Conditions the study is for
- Increased Drug Resistance
- What is being tested?
- Factors associated
- How many people
- 10,000 participants
- Where
- 1 siteColombia
- Study dates
- 1 Sep 2023to 30 Jun 2024
- 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 130 years
- All sexes
- Child, Adult, Older adult
Study population: The population included in the study were the records of microbiological isolation for surveillance from the Public Health Laboratory of Meta State Secretary of Health.
Who may be able to join
- All records with results from microbial isolation and antimicrobial resistance profile.
Who cannot join
- Records of quality control; no information on resistance or susceptibility.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Departamental de Villavicencio
Villavicencio, Meta Department, 50001
About this study
Official title: Antimicrobial Resistance Profiles in Healthcare Facilities From Meta State, Colombia: A Retrospective Observational Study From 2018-2022
Introduction: Healthcare-associated infections cause a burden in morbidity and mortality, and they increase the financial cost of care. Nevertheless, they are not limited to setting factors, and several community conditions and contexts are linked. Clinical laboratories from hospitals report monthly to the Public Health Laboratory.
Objective: The study aims to establish the antimicrobial resistance profile of the most significant bacteria involved in healthcare-associated infections in Meta State hospitals.
Read more
Methodology: The researchers designed a retrospective observational trial with the records from samples and origin, microbial findings, and antibiogram. The outcome was the mechanism for antimicrobial resistance. The information from the State Public Health Laboratory database was exported to Excel for analysis.
Conclusions: The outlook of Enterobacteriaceae and Staphylococcus aureus antimicrobial resistance in hospitals from Meta State will be revealed. Comprehensive strategies for mitigation, including continuous microbiological surveillance, are needed.
Read the detailed description
Healthcare-associated infections (HCAIs) affect patients' security and quality of care. Several of them develop infections during their hospital stay, especially in the ICU, and the number is higher in low-middle-income countries. It confers an additional burden on hospitals, with higher use of resources and costs. The magnitude of the problem is not understood completely due to discrepancies in results and heterogeneous studies.
Additionally, HCAIs are associated with increased morbidity and disability, but the studies are unsure of the effect on mortality.
Microorganisms are ubiquitous in hospital environments and diverse in patients, families, and healthcare personnel. Some are carriers of antimicrobial resistance mechanisms (AMR) and are transmissible to other microorganisms. Studies with genetic sequencing show a fundamental role of such colonization as a reservoir for AMR that limits the efficacy of therapy since admission. Such technology is not available to most hospitals to screen environments or people. Such interaction favors an interchange of microbiome (directly or indirectly) as a requirement for the advent of HCAIs.
It is known that HCAIs by MDR (multidrug resistance) bacteria are associated with an increase in mortality (OR 1.61; 1.36-1.90); it is not clear if it is due to the problem in the quality of care or the health conditions that promotes the infection.
The frequency of HCAIs is higher in Latin America than in the United States or Europe. The Centers for Disease Control and Prevention regularly monitor DAI (device-associated infections) from several years ago, and they are of reference worldwide.
Some countries have developed microbiological surveillance systems to follow up on changes in resistance phenotypes. They reveal benign resistance patterns in Gram-negative in contrast to the reports from studies in Colombia. Such results highlight the importance of analyzing the information provided by such monitoring to prioritize actions and resources to modulate the impact of the increased resistance.
- Conditions
- Increased Drug Resistance
- Being tested
- Factors associated
- Keywords
- Patient Safety, Healthcare Quality Assurance, Cross Infection, Increased Drug Resistance, Colombia
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factors associatedOther
Factors associated with the type of resistance by microorganisms.
| Study group | Role | What they receive |
|---|---|---|
| Escherichia coli producing ESBL | Ceftazidime or cefotaxime resistance. Receives: Other: Factors associated | |
| Klebsiella pneumoniae producing ESBL | Ceftazidime or cefotaxime resistance. Receives: Other: Factors associated | |
| Klebsiella pneumoniae resistant to carbapenem | Ertapenem resistance. Receives: Other: Factors associated | |
| Pseudomonas aeruginosa resistant to carbapenems | Imipenem or meropenem resistance. Receives: Other: Factors associated | |
| Staphylococcus aureus resistant to methicillin | Methicillin resistance. Receives: Other: Factors associated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of microorganisms resistant to the antimicrobial
Mechanism of resistance by type of microorganisms. ESBL in E. coli and K. pneumoniae, carbapenemase in K.pneumoniae and Pseudomonas, and methicilinase in S. aureus.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Nov 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Increased Drug ResistanceStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative University of Colombia
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez, MD, Principal investigator, Cooperative University of Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044272
- Sponsor's protocol ID
- GRIVI_2023_03_RAM
- Status last verified
- Dec 2024
- First submitted
- 20 Jul 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The database is access restricted in the university repository.
Publications
Kawata S, Morimoto S, Kosai K, Kawamoto Y, Nakashima Y, Morinaga Y, Yanagihara K, Yoshida LM, Moriuchi H. The fecal carriage rate of extended-spectrum beta-lactamase-producing or carbapenem-resistant Enterobacterales among Japanese infants in the community at the 4-month health examination in a rural city. Front Cell Infect Microbiol. 2023 Jun 14;13:1168451. doi: 10.3389/fcimb.2023.1168451. eCollection 2023.
PubMed 37389210Zhou Y, Zhou S, Peng J, Min L, Chen Q, Ke J. Bacterial distribution and drug resistance in blood samples of children in Jiangxi Region, 2017-2021. Front Cell Infect Microbiol. 2023 Jun 22;13:1163312. doi: 10.3389/fcimb.2023.1163312. eCollection 2023.
PubMed 37424793Quiros RE, Bardossy AC, Angeleri P, Zurita J, Aleman Espinoza WR, Carneiro M, Guerra S, Medina J, Castaneda Luquerna X, Guerra A, Vega S, Cuellar Ponce de Leon LE, Munita J, Escobar ED, Maki G, Prentiss T, Zervos M; PROA-LATAM Project Group. Antimicrobial stewardship programs in adult intensive care units in Latin America: Implementation, assessments, and impact on outcomes. Infect Control Hosp Epidemiol. 2022 Feb;43(2):181-190. doi: 10.1017/ice.2021.80. Epub 2021 Apr 8.
PubMed 33829982Sharma A, Luvsansharav UO, Paul P, Lutgring JD, Call DR, Omulo S, Laserson K, Araos R, Munita JM, Verani J, Chowdhury F, Muneer SM, Espinosa-Bode A, Ramay B, Cordon-Rosales C, Kumar CPG, Bhatnagar T, Gupta N, Park B, Smith RM. Multi-country cross-sectional study of colonization with multidrug-resistant organisms: protocol and methods for the Antibiotic Resistance in Communities and Hospitals (ARCH) studies. BMC Public Health. 2021 Jul 16;21(1):1412. doi: 10.1186/s12889-021-11451-y.
PubMed 34271883Alzamora MC, Echevarria AC, Ferraro VM, Riveros MD, Zambruni M, Ochoa TJ. [Antimicrobial resistance of commensal Escherichia coli strains in children of two rural communities in Peru]. Rev Peru Med Exp Salud Publica. 2019 Jul-Sep;36(3):459-463. doi: 10.17843/rpmesp.2019.363.4366. Epub 2019 Dec 2. Spanish.
PubMed 31800939Revoredo Rego F, Huaman Egoavil E, Zegarra Cavani S, Auris Mora H, Valderrama Barrientos R. [Microbiological and resistance profiles of community acquired and nosocomial intra abdominal infections in surgery of National Hospital Guillermo Almenara, Lima, Peru]. Rev Gastroenterol Peru. 2016 Apr-Jun;36(2):115-22. Spanish.
PubMed 27409087Vallejo M, Cuesta DP, Florez LE, Correa A, Llanos CE, Isaza B, Vanegas S, Osorio J, Casanova L, Villegas MV. [Clinical and microbiological characteristics of complicated intra-abdominal infection in Colombia: a multicenter study]. Rev Chilena Infectol. 2016 Jun;33(3):261-7. doi: 10.4067/S0716-10182016000300002. Spanish.
PubMed 27598273Arias-Flores R, Rosado-Quiab U, Vargas-Valerio A, Grajales-Muniz C. [Microorganisms responsible of nosocomial infections in the Mexican Social Security Institute]. Rev Med Inst Mex Seguro Soc. 2016 Jan-Feb;54(1):20-4. Spanish.
PubMed 26820194Mata-Hernandez A, Rivera-Villa AH, Miguel-Perez A, Perez-Atanasio JM, Torres-Gonzalez R. [Sensitivity and antibiotic resistance in infections of the musculoskeletal system]. Rev Med Inst Mex Seguro Soc. 2016;54 Suppl 3:S320-S324. Spanish.
PubMed 27855057Morganti L, Cordova E, Cassini E, Gomez N, Lopez Moral L, Badia M, Rodriguez C. [Antimicrobial susceptibility of Gram-negative bacilli of community acquired intra-abdominal infections in a hospital at Buenos Aires, Argentina]. Rev Esp Quimioter. 2016 Aug;29(4):202-5. Epub 2016 Jun 17. Spanish.
PubMed 27318458Ruiz-Garbajosa P, Canton R. [Epidemiology of multi-drug resistant gramnegative bacilli]. Rev Esp Quimioter. 2016 Sep;29 Suppl 1:21-5. Spanish.
PubMed 27608308De La Rosa G, Leon AL, Jaimes F. [Epidemiology and prognosis of patients with bloodstream infection in 10 hospitals in Colombia]. Rev Chilena Infectol. 2016 Apr;33(2):141-9. doi: 10.4067/S0716-10182016000200003. Spanish.
PubMed 27314991Salgado P, Gilsanz F, Maseda E. [Resistant gram-negative bacteria. Therapeutic approach and risk factors]. Rev Esp Quimioter. 2016 Sep;29 Suppl 1:26-30. Spanish.
PubMed 27608309Moya-Dionisio V, Diaz-Zabala M, Ibanez-Fernandez A, Suarez-Leiva P, Martinez-Suarez V, Ordonez-Alvarez FA, Santos-Rodriguez F. [Uropathogen pattern and antimicrobial susceptibility in positive urinary cultures isolates from paediatric patients]. Rev Esp Quimioter. 2016 Jun;29(3):146-50. Epub 2016 Apr 19. Spanish.
PubMed 27092771Cercenado E. [Epidemiology of the infection by resistant Gram-positive microorganisms]. Rev Esp Quimioter. 2016 Sep;29 Suppl 1:6-9. Spanish.
PubMed 27608305
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Resistance Profiles in Healthcare Facilities From Meta State, Colombia: A Retrospective Observational Study From 2018-2022
- ClinicalTrials.gov ID
- NCT06044272
- Acronym / sponsor ID
- GRIVI_2023_03_RAM
- Conditions
- Increased Drug Resistance
- Keywords
- Patient Safety, Healthcare Quality Assurance, Cross Infection, Increased Drug Resistance, Colombia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Collaborators
- Cooperative University of Colombia
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Sep 2023 (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.
Introduction: Healthcare-associated infections cause a burden in morbidity and mortality, and they increase the financial cost of care. Nevertheless, they are not limited to setting factors, and several community conditions and contexts are linked. Clinical laboratories from hospitals report monthly to the Public Health Laboratory.
Objective: The study aims to establish the antimicrobial resistance profile of the most significant bacteria involved in healthcare-associated infections in Meta State hospitals.
Methodology: The researchers designed a retrospective observational trial with the records from samples and origin, microbial findings, and antibiogram. The outcome was the mechanism for antimicrobial resistance. The information from the State Public Health Laboratory database was exported to Excel for analysis.
Conclusions: The outlook of Enterobacteriaceae and Staphylococcus aureus antimicrobial resistance in hospitals from Meta State will be revealed. Comprehensive strategies for mitigation, including continuous microbiological surveillance, are needed.
Detailed description
Healthcare-associated infections (HCAIs) affect patients' security and quality of care. Several of them develop infections during their hospital stay, especially in the ICU, and the number is higher in low-middle-income countries. It confers an additional burden on hospitals, with higher use of resources and costs. The magnitude of the problem is not understood completely due to discrepancies in results and heterogeneous studies.
Additionally, HCAIs are associated with increased morbidity and disability, but the studies are unsure of the effect on mortality.
Microorganisms are ubiquitous in hospital environments and diverse in patients, families, and healthcare personnel. Some are carriers of antimicrobial resistance mechanisms (AMR) and are transmissible to other microorganisms. Studies with genetic sequencing show a fundamental role of such colonization as a reservoir for AMR that limits the efficacy of therapy since admission. Such technology is not available to most hospitals to screen environments or people. Such interaction favors an interchange of microbiome (directly or indirectly) as a requirement for the advent of HCAIs.
It is known that HCAIs by MDR (multidrug resistance) bacteria are associated with an increase in mortality (OR 1.61; 1.36-1.90); it is not clear if it is due to the problem in the quality of care or the health conditions that promotes the infection.
The frequency of HCAIs is higher in Latin America than in the United States or Europe. The Centers for Disease Control and Prevention regularly monitor DAI (device-associated infections) from several years ago, and they are of reference worldwide.
Some countries have developed microbiological surveillance systems to follow up on changes in resistance phenotypes. They reveal benign resistance patterns in Gram-negative in contrast to the reports from studies in Colombia. Such results highlight the importance of analyzing the information provided by such monitoring to prioritize actions and resources to modulate the impact of the increased resistance.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Escherichia coli producing ESBL | – | Other: Factors associatedCeftazidime or cefotaxime resistance. |
| Klebsiella pneumoniae producing ESBL | – | Other: Factors associatedCeftazidime or cefotaxime resistance. |
| Klebsiella pneumoniae resistant to carbapenem | – | Other: Factors associatedErtapenem resistance. |
| Pseudomonas aeruginosa resistant to carbapenems | – | Other: Factors associatedImipenem or meropenem resistance. |
| Staphylococcus aureus resistant to methicillin | – | Other: Factors associatedMethicillin resistance. |
Who may qualify
- Ages
- Up to 130 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The population included in the study were the records of microbiological isolation for surveillance from the Public Health Laboratory of Meta State Secretary of Health.
Key inclusion criteria (1 listed)
- All records with results from microbial isolation and antimicrobial resistance profile.
Key exclusion criteria (1 listed)
- Records of quality control; no information on resistance or susceptibility.
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 |
|---|---|---|
| Factors associatedFactors associated with the type of resistance by microorganisms. | Other | Escherichia coli producing ESBL, Klebsiella pneumoniae producing ESBL, Klebsiella pneumoniae resistant to carbapenem, Pseudomonas aeruginosa resistant to carbapenems, Staphylococcus aureus resistant to methicillin |
Primary outcome
Number of microorganisms resistant to the antimicrobial
Time frame: 28 days
Mechanism of resistance by type of microorganisms. ESBL in E. coli and K. pneumoniae, carbapenemase in K.pneumoniae and Pseudomonas, and methicilinase in S. aureus.
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 12 Dec 2024.
- Results publication: PubMed 37389210Kawata S, Morimoto S, Kosai K, Kawamoto Y, Nakashima Y, Morinaga Y, Yanagihara K, Yoshida LM, Moriuchi H. The fecal carriage rate of extended-spectrum beta-lactamase-producing or carbapenem-resistant Enterobacterales among Japanese infants in the community at the 4-month health examination in a rural city. Front Cell Infect Microbiol. 2023 Jun 14;13:1168451. doi: 10.3389/fcimb.2023.1168451. eCollection 2023.
- Results publication: PubMed 37424793Zhou Y, Zhou S, Peng J, Min L, Chen Q, Ke J. Bacterial distribution and drug resistance in blood samples of children in Jiangxi Region, 2017-2021. Front Cell Infect Microbiol. 2023 Jun 22;13:1163312. doi: 10.3389/fcimb.2023.1163312. eCollection 2023.
- Results publication: PubMed 33829982Quiros RE, Bardossy AC, Angeleri P, Zurita J, Aleman Espinoza WR, Carneiro M, Guerra S, Medina J, Castaneda Luquerna X, Guerra A, Vega S, Cuellar Ponce de Leon LE, Munita J, Escobar ED, Maki G, Prentiss T, Zervos M; PROA-LATAM Project Group. Antimicrobial stewardship programs in adult intensive care units in Latin America: Implementation, assessments, and impact on outcomes. Infect Control Hosp Epidemiol. 2022 Feb;43(2):181-190. doi: 10.1017/ice.2021.80. Epub 2021 Apr 8.
- Results publication: PubMed 34271883Sharma A, Luvsansharav UO, Paul P, Lutgring JD, Call DR, Omulo S, Laserson K, Araos R, Munita JM, Verani J, Chowdhury F, Muneer SM, Espinosa-Bode A, Ramay B, Cordon-Rosales C, Kumar CPG, Bhatnagar T, Gupta N, Park B, Smith RM. Multi-country cross-sectional study of colonization with multidrug-resistant organisms: protocol and methods for the Antibiotic Resistance in Communities and Hospitals (ARCH) studies. BMC Public Health. 2021 Jul 16;21(1):1412. doi: 10.1186/s12889-021-11451-y.
- Results publication: PubMed 31800939Alzamora MC, Echevarria AC, Ferraro VM, Riveros MD, Zambruni M, Ochoa TJ. [Antimicrobial resistance of commensal Escherichia coli strains in children of two rural communities in Peru]. Rev Peru Med Exp Salud Publica. 2019 Jul-Sep;36(3):459-463. doi: 10.17843/rpmesp.2019.363.4366. Epub 2019 Dec 2. Spanish.
- Results publication: PubMed 27409087Revoredo Rego F, Huaman Egoavil E, Zegarra Cavani S, Auris Mora H, Valderrama Barrientos R. [Microbiological and resistance profiles of community acquired and nosocomial intra abdominal infections in surgery of National Hospital Guillermo Almenara, Lima, Peru]. Rev Gastroenterol Peru. 2016 Apr-Jun;36(2):115-22. Spanish.
- Results publication: PubMed 27598273Vallejo M, Cuesta DP, Florez LE, Correa A, Llanos CE, Isaza B, Vanegas S, Osorio J, Casanova L, Villegas MV. [Clinical and microbiological characteristics of complicated intra-abdominal infection in Colombia: a multicenter study]. Rev Chilena Infectol. 2016 Jun;33(3):261-7. doi: 10.4067/S0716-10182016000300002. Spanish.
- Results publication: PubMed 26820194Arias-Flores R, Rosado-Quiab U, Vargas-Valerio A, Grajales-Muniz C. [Microorganisms responsible of nosocomial infections in the Mexican Social Security Institute]. Rev Med Inst Mex Seguro Soc. 2016 Jan-Feb;54(1):20-4. Spanish.
- Results publication: PubMed 27855057Mata-Hernandez A, Rivera-Villa AH, Miguel-Perez A, Perez-Atanasio JM, Torres-Gonzalez R. [Sensitivity and antibiotic resistance in infections of the musculoskeletal system]. Rev Med Inst Mex Seguro Soc. 2016;54 Suppl 3:S320-S324. Spanish.
- Results publication: PubMed 27318458Morganti L, Cordova E, Cassini E, Gomez N, Lopez Moral L, Badia M, Rodriguez C. [Antimicrobial susceptibility of Gram-negative bacilli of community acquired intra-abdominal infections in a hospital at Buenos Aires, Argentina]. Rev Esp Quimioter. 2016 Aug;29(4):202-5. Epub 2016 Jun 17. Spanish.
- Results publication: PubMed 27608308Ruiz-Garbajosa P, Canton R. [Epidemiology of multi-drug resistant gramnegative bacilli]. Rev Esp Quimioter. 2016 Sep;29 Suppl 1:21-5. Spanish.
- Results publication: PubMed 27314991De La Rosa G, Leon AL, Jaimes F. [Epidemiology and prognosis of patients with bloodstream infection in 10 hospitals in Colombia]. Rev Chilena Infectol. 2016 Apr;33(2):141-9. doi: 10.4067/S0716-10182016000200003. Spanish.
- Individual participant dataSharing planned: No. The database is access restricted in the university repository.
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.
Norton Perez, MD principal investigator
Cooperative University of Colombia
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 Increased Drug Resistance, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
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 1 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 12 Dec 2024. 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 Colombia. 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 microorganisms resistant to the antimicrobial (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06044272, which also lists 20 linked publications.
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 12 Dec 2024.