Cystic FibrosispHALT NTMNCT05686837
Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria
An observational study of Cystic Fibrosis and Nontuberculous Mycobacterial Pulmonary Infection, run by University of North Carolina, Chapel Hill at 7 sites in United States.
Trial summary
Pulmonary NTM infection is recognized as one of the most challenging infections to treat among people with cystic fibrosis (PwCF), notable for prolonged treatment courses and often poor response to therapy. Positive cultures for NTM occur in about 20% of children and adults with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 1 month to 99 years
- Conditions the study is for
- Cystic Fibrosis, Nontuberculous Mycobacterial Pulmonary Infection
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Dec 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 month to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female participant of any age who has a history of respiratory NTM or a first positive NTM culture collected as part of routine clinical care from expectorated sputum, induced sputum, throat/oropharyngeal swab and/or bronchoalveolar lavage.
Who may be able to join
- Diagnosis of CF consistent with the 2017 CFF guidelines.
- Male or female participant of any age who has a history of NTM or a first positive NTM culture collected as part of routine clinical care from expectorated sputum, induced sputum, throat/oropharyngeal swab and/or bronchoalveolar lavage.
Who cannot join
- No diagnosis of CF
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Dell Children's Ascension
Austin, Texas, 78723
Johns Hopkins Cystic Fibrosis Center
Baltimore, Maryland, 21287
UVA Health University Medical Center
Charlottesville, Virginia, 22908
The University of Vermont Medical Center
Colchester, Vermont, 05446
UT Southwestern Medical Center
Dallas, Texas, 75309
National Jewish Health
Denver, Colorado, 80206
UW Medical Center
Seattle, Washington, 98195
About this study
Official title: Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria Among People With Cystic Fibrosis
Pulmonary NTM infection is recognized as one of the most challenging infections to treat among people with cystic fibrosis (PwCF), notable for prolonged treatment courses and often poor response to therapy. Positive cultures for NTM occur in about 20% of children and adults with cystic fibrosis (CF). However, the source of NTM infection, modes of transmission, and exposure risks are poorly understood. It is thought that NTM is primarily acquired from environmental sites including soil and water as well as water supply systems to homes, hospitals, and clinics and from aerosols generated by flowing water from taps, showers, and fountains. Nonetheless, no direct molecular link has been established between environmental NTM and respiratory CF NTM. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers worldwide. Widespread global transmission of NTM, potentially via person-to-person transmission of fomites and aerosols has been reported. The parent HALT NTM study developed and published a standardized epidemiologic outbreak toolkit for investigation of healthcare-associated NTM outbreaks in CF Care Centers. The investigators are now moving to a prospective investigation, with the long-term goal of real-time early identification and mitigation of potential NTM outbreak investigations coupled with healthcare environmental sampling and home of residence watershed analysis of PwCF identified as belonging to an NTM cluster and receiving care at a single CF Care Center.
Read the detailed description
This is a prospective, multicenter, nonrandomized study to investigate potential NTM outbreaks in the six CF Care Centers currently enrolled in the HALT NTM study. The study will investigate potential episodes of healthcare-associated NTM transmission and/or acquisition within participating U.S. Care Centers, coupled with healthcare environmental sampling and home of residence watershed analysis.
PART A / Epidemiologic Investigation:
The Colorado NTM Outcome Measure Advancement Core National Resource Centers (CO-NRC) provides a national reference laboratory for CF NTM. NTM respiratory isolates received from CF Care Centers around the U.S. undergo culture, molecular identification, antimicrobial susceptibility, and whole genome sequencing (WGS). Using this approach, the CO-NRC has identified clusters of NTM isolates, defined as highly similar strains at the genomic level, harbored by two or more people with CF (pwCF) who are cared for at the same CF Care Center. These identifications have heightened the concern for potential healthcare-associated NTM acquisition originating from patient-to- patient transmission or a common environmental source within Centers.
Using integrated clinical and epidemiological research methods, the parent HALT NTM study developed and validated a healthcare-associated epidemiologic investigation toolkit that can identify overlaps in source(s) of care between patients with highly similar NTM isolates in a Center. The parent HALT NTM toolkit facilitates a stepwise process by which individual Centers perform epidemiologic evaluation of patients identified by the CO-NRC as being infected with clustered NTM isolates.
The retrospective parent HALT NTM study of potential NTM outbreaks has been completed at six participating CF Care Centers. In the pHALT NTM study, participating sites will prospectively submit all respiratory NTM isolates from all PwCF receiving routine care over a two-year period to NJH Advanced Diagnostic Laboratories. All NTM isolates will be stored in the Biobank within the NTM Culture, Biorepository and Coordinating Core (Project ID: HS3149) and used for research purposes. The CO-NRC will utilize an honest broker to de-identify NTM isolates and will culture, bank, and extract DNA. The CO-NRC de-identified isolates will then be analyzed as previously described.
When highly related clusters are identified, the HALT NTM epidemiologic investigation toolkit will be independently used by each participating Center to identify overlaps in source(s) of care between patients with highly similar NTM isolates. Additionally, PwCF identified as being infected with highly similar NTM isolates will be asked to complete an online survey. The survey will ask the subject's basic demographic information, query their interactions with other PwCF, and document where they receive CF care.
PART B / Dust and Water Biofilm Collection:
Clustered NTM isolates could originate from a shared healthcare water source. Biofilms from healthcare dust and water supplies will be collected and NTM recovered, identified, and sequenced to determine if the respiratory CF NTM strain genotype is similar to those recovered from the healthcare dust and water supply.
Part C/Home of Residence Watershed Mapping: Clustered NTM isolates could originate from a shared home of residence water supply. PwCF having clustered NTM isolates will be asked to complete an online survey. The survey will ask subjects for their current and last 2 year's home address. The home of residence for PwCF identified in clusters will be extracted and geocoded to latitude and longitude coordinates and mapped to Hydrologic Unit Code level watersheds to determine if clustered PwCF share a common home of residence water supply source.
- Keywords
- epidemiology, outbreak investigation, transmission, acquisition, nontuberculous mycobacteria
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People infected with NTM isolates identified in a cluster | All people with CF infected with NTM respiratory isolated identified in a cluster based on whole genome sequencing of the core genome will undergo epidemiologic investigation and home of residence watersheds will be mapped. | |
| People infected with NTM isolates not identified in a cluster | All people with CF infected with NTM respiratory isolated not identified in a cluster based on whole genome sequencing of the core genome will undergo epidemiologic investigation and home of residence watersheds will be mapped. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiologic Investigation
Identification of a shared healthcare-associated source(s) between patients in a CF Care Center.
Measured: 3 years
Dust and Water Biofilm Collection
Identification of healthcare dust and water biofilm NTM isolates that are highly related to the isolates recovered from PwCF.
Measured: 3 years
Home of Residence Watershed Mapping
The primary endpoint is identification of common watersheds among pwCF infected with clustered NTM isolate.
Measured: 3 years
Secondary outcomes (2)
Epidemiologic Investigation
Incidence and prevalence of CF NTM species/subspecies by geographical region. Between Center comparisons of genetic similarity and patterns of potential transmission.
Banking of isolates for ex vivo analysis.
Measured: 3 years
Dust and Water Biofilm Collection
Incidence and prevalence of healthcare-associated dust and water biofilm NTM species/subspecies by geographical region.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start28 Dec 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Jewish Health, University of Texas at Tyler, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Jane E. Gross, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686837
- Sponsor's protocol ID
- 24-2792
- Other IDs
- HS-3175
- Acronym
- pHALT NTM
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available. All IPD will be made available upon request.
Publications
Gross JE, Fullmer J, McClelland G, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, de Moura VCN, Daley CL, Strong M, Nick JA. Genomic and epidemiologic investigation of Mycobacterium abscessus isolates in a cystic fibrosis center to determine potential routes of transmission. J Cyst Fibros. 2025 Nov;24(6):1114-1123. doi: 10.1016/j.jcf.2025.07.003. Epub 2025 Aug 8.
PubMed 40783340Gross JE, Teneback CC, Sweet JG, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, Calado Nogueira de Moura V, Daley CL, Strong M, Davidson RM, Nick JA. Molecular Epidemiologic Investigation of Mycobacterium intracellulare Subspecies chimaera Lung Infections at an Adult Cystic Fibrosis Program. Ann Am Thorac Soc. 2023 May;20(5):677-686. doi: 10.1513/AnnalsATS.202209-779OC.
PubMed 36656594Gross JE, Caceres S, Poch K, Epperson LE, Hasan NA, Jia F, Calado Nogueira de Moura V, Strand M, Lipner EM, Honda JR, Strong M, Davidson RM, Daley CL, Nick JA. Prospective healthcare-associated links in transmission of nontuberculous mycobacteria among people with cystic fibrosis (pHALT NTM) study: Rationale and study design. PLoS One. 2023 Dec 20;18(12):e0291910. doi: 10.1371/journal.pone.0291910. eCollection 2023.
PubMed 38117792Gross JE, Finklea JD, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, Nogueira de Moura VC, Daley CL, Strong M, Nick JA. Genomic epidemiology of Mycobacterium abscessus at an adult cystic fibrosis programme reveals low potential for healthcare-associated transmission. ERJ Open Res. 2024 Jul 8;10(4):00165-2024. doi: 10.1183/23120541.00165-2024. eCollection 2024 Jul.
PubMed 38978544Gross JE, Caceres S, Poch K, Hasan NA, Davidson RM, Epperson LE, Lipner E, Vang C, Honda JR, Strand M, Strong M, Saiman L, Prevots DR, Olivier KN, Nick JA. Healthcare-associated links in transmission of nontuberculous mycobacteria among people with cystic fibrosis (HALT NTM) study: Rationale and study design. PLoS One. 2021 Dec 20;16(12):e0261628. doi: 10.1371/journal.pone.0261628. eCollection 2021.
PubMed 34929010Gross JE, Caceres S, Poch K, Hasan NA, Jia F, Epperson LE, Lipner E, Vang C, Honda JR, Strand M, Calado Nogueira de Moura V, Daley CL, Strong M, Davidson RM, Nick JA. Investigating Nontuberculous Mycobacteria Transmission at the Colorado Adult Cystic Fibrosis Program. Am J Respir Crit Care Med. 2022 May 1;205(9):1064-1074. doi: 10.1164/rccm.202108-1911OC.
PubMed 35085056
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria Among People With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05686837
- Acronym / sponsor ID
- pHALT NTM / 24-2792
- Keywords
- epidemiology, outbreak investigation, transmission, acquisition, nontuberculous mycobacteria
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Jewish Health, University of Texas at Tyler, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jan 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.
Pulmonary NTM infection is recognized as one of the most challenging infections to treat among people with cystic fibrosis (PwCF), notable for prolonged treatment courses and often poor response to therapy. Positive cultures for NTM occur in about 20% of children and adults with cystic fibrosis (CF). However, the source of NTM infection, modes of transmission, and exposure risks are poorly understood. It is thought that NTM is primarily acquired from environmental sites including soil and water as well as water supply systems to homes, hospitals, and clinics and from aerosols generated by flowing water from taps, showers, and fountains. Nonetheless, no direct molecular link has been established between environmental NTM and respiratory CF NTM. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers worldwide. Widespread global transmission of NTM, potentially via person-to-person transmission of fomites and aerosols has been reported. The parent HALT NTM study developed and published a standardized epidemiologic outbreak toolkit for investigation of healthcare-associated NTM outbreaks in CF Care Centers. The investigators are now moving to a prospective investigation, with the long-term goal of real-time early identification and mitigation of potential NTM outbreak investigations coupled with healthcare environmental sampling and home of residence watershed analysis of PwCF identified as belonging to an NTM cluster and receiving care at a single CF Care Center.
Detailed description
This is a prospective, multicenter, nonrandomized study to investigate potential NTM outbreaks in the six CF Care Centers currently enrolled in the HALT NTM study. The study will investigate potential episodes of healthcare-associated NTM transmission and/or acquisition within participating U.S. Care Centers, coupled with healthcare environmental sampling and home of residence watershed analysis.
PART A / Epidemiologic Investigation:
The Colorado NTM Outcome Measure Advancement Core National Resource Centers (CO-NRC) provides a national reference laboratory for CF NTM. NTM respiratory isolates received from CF Care Centers around the U.S. undergo culture, molecular identification, antimicrobial susceptibility, and whole genome sequencing (WGS). Using this approach, the CO-NRC has identified clusters of NTM isolates, defined as highly similar strains at the genomic level, harbored by two or more people with CF (pwCF) who are cared for at the same CF Care Center. These identifications have heightened the concern for potential healthcare-associated NTM acquisition originating from patient-to- patient transmission or a common environmental source within Centers.
Using integrated clinical and epidemiological research methods, the parent HALT NTM study developed and validated a healthcare-associated epidemiologic investigation toolkit that can identify overlaps in source(s) of care between patients with highly similar NTM isolates in a Center. The parent HALT NTM toolkit facilitates a stepwise process by which individual Centers perform epidemiologic evaluation of patients identified by the CO-NRC as being infected with clustered NTM isolates.
The retrospective parent HALT NTM study of potential NTM outbreaks has been completed at six participating CF Care Centers. In the pHALT NTM study, participating sites will prospectively submit all respiratory NTM isolates from all PwCF receiving routine care over a two-year period to NJH Advanced Diagnostic Laboratories. All NTM isolates will be stored in the Biobank within the NTM Culture, Biorepository and Coordinating Core (Project ID: HS3149) and used for research purposes. The CO-NRC will utilize an honest broker to de-identify NTM isolates and will culture, bank, and extract DNA. The CO-NRC de-identified isolates will then be analyzed as previously described.
When highly related clusters are identified, the HALT NTM epidemiologic investigation toolkit will be independently used by each participating Center to identify overlaps in source(s) of care between patients with highly similar NTM isolates. Additionally, PwCF identified as being infected with highly similar NTM isolates will be asked to complete an online survey. The survey will ask the subject's basic demographic information, query their interactions with other PwCF, and document where they receive CF care.
PART B / Dust and Water Biofilm Collection:
Clustered NTM isolates could originate from a shared healthcare water source. Biofilms from healthcare dust and water supplies will be collected and NTM recovered, identified, and sequenced to determine if the respiratory CF NTM strain genotype is similar to those recovered from the healthcare dust and water supply.
Part C/Home of Residence Watershed Mapping: Clustered NTM isolates could originate from a shared home of residence water supply. PwCF having clustered NTM isolates will be asked to complete an online survey. The survey will ask subjects for their current and last 2 year's home address. The home of residence for PwCF identified in clusters will be extracted and geocoded to latitude and longitude coordinates and mapped to Hydrologic Unit Code level watersheds to determine if clustered PwCF share a common home of residence water supply source.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People infected with NTM isolates identified in a cluster | – | –All people with CF infected with NTM respiratory isolated identified in a cluster based on whole genome sequencing of the core genome will undergo epidemiologic investigation and home of residence watersheds will be mapped. |
| People infected with NTM isolates not identified in a cluster | – | –All people with CF infected with NTM respiratory isolated not identified in a cluster based on whole genome sequencing of the core genome will undergo epidemiologic investigation and home of residence watersheds will be mapped. |
Who may qualify
- Ages
- 1 month to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female participant of any age who has a history of respiratory NTM or a first positive NTM culture collected as part of routine clinical care from expectorated sputum, induced sputum, throat/oropharyngeal swab and/or bronchoalveolar lavage.
Key inclusion criteria (2 listed)
- Diagnosis of CF consistent with the 2017 CFF guidelines.
- Male or female participant of any age who has a history of NTM or a first positive NTM culture collected as part of routine clinical care from expectorated sputum, induced sputum, throat/oropharyngeal swab and/or bronchoalveolar lavage.
Key exclusion criteria (1 listed)
- No diagnosis of CF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiologic Investigation
Time frame: 3 years
Identification of a shared healthcare-associated source(s) between patients in a CF Care Center.
Dust and Water Biofilm Collection
Time frame: 3 years
Identification of healthcare dust and water biofilm NTM isolates that are highly related to the isolates recovered from PwCF.
Home of Residence Watershed Mapping
Time frame: 3 years
The primary endpoint is identification of common watersheds among pwCF infected with clustered NTM isolate.
2 secondary outcomes
Epidemiologic Investigation
Time frame: 3 years
Dust and Water Biofilm Collection
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Results publication: PubMed 40783340Gross JE, Fullmer J, McClelland G, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, de Moura VCN, Daley CL, Strong M, Nick JA. Genomic and epidemiologic investigation of Mycobacterium abscessus isolates in a cystic fibrosis center to determine potential routes of transmission. J Cyst Fibros. 2025 Nov;24(6):1114-1123. doi: 10.1016/j.jcf.2025.07.003. Epub 2025 Aug 8.
- Results publication: PubMed 36656594Gross JE, Teneback CC, Sweet JG, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, Calado Nogueira de Moura V, Daley CL, Strong M, Davidson RM, Nick JA. Molecular Epidemiologic Investigation of Mycobacterium intracellulare Subspecies chimaera Lung Infections at an Adult Cystic Fibrosis Program. Ann Am Thorac Soc. 2023 May;20(5):677-686. doi: 10.1513/AnnalsATS.202209-779OC.
- Results publication: PubMed 38117792Gross JE, Caceres S, Poch K, Epperson LE, Hasan NA, Jia F, Calado Nogueira de Moura V, Strand M, Lipner EM, Honda JR, Strong M, Davidson RM, Daley CL, Nick JA. Prospective healthcare-associated links in transmission of nontuberculous mycobacteria among people with cystic fibrosis (pHALT NTM) study: Rationale and study design. PLoS One. 2023 Dec 20;18(12):e0291910. doi: 10.1371/journal.pone.0291910. eCollection 2023.
- Results publication: PubMed 38978544Gross JE, Finklea JD, Caceres SM, Poch KR, Hasan NA, Jia F, Epperson LE, Lipner EM, Vang CK, Honda JR, Strand MJ, Nogueira de Moura VC, Daley CL, Strong M, Nick JA. Genomic epidemiology of Mycobacterium abscessus at an adult cystic fibrosis programme reveals low potential for healthcare-associated transmission. ERJ Open Res. 2024 Jul 8;10(4):00165-2024. doi: 10.1183/23120541.00165-2024. eCollection 2024 Jul.
- Results publication: PubMed 34929010Gross JE, Caceres S, Poch K, Hasan NA, Davidson RM, Epperson LE, Lipner E, Vang C, Honda JR, Strand M, Strong M, Saiman L, Prevots DR, Olivier KN, Nick JA. Healthcare-associated links in transmission of nontuberculous mycobacteria among people with cystic fibrosis (HALT NTM) study: Rationale and study design. PLoS One. 2021 Dec 20;16(12):e0261628. doi: 10.1371/journal.pone.0261628. eCollection 2021.
- Results publication: PubMed 35085056Gross JE, Caceres S, Poch K, Hasan NA, Jia F, Epperson LE, Lipner E, Vang C, Honda JR, Strand M, Calado Nogueira de Moura V, Daley CL, Strong M, Davidson RM, Nick JA. Investigating Nontuberculous Mycobacteria Transmission at the Colorado Adult Cystic Fibrosis Program. Am J Respir Crit Care Med. 2022 May 1;205(9):1064-1074. doi: 10.1164/rccm.202108-1911OC.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available. All IPD will be made available upon request.
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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.
Jane E. Gross, MD, PhD principal investigator
University of North Carolina, Chapel Hill
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Nontuberculous Mycobacterial Pulmonary Infection, run by University of North Carolina, Chapel Hill at 7 sites in United States.
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: enrolling by invitation, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Epidemiologic Investigation (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT05686837, which also lists 6 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 3 Nov 2026.