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NCT05686837Enrolling by invitation

Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria

Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria Among People With Cystic Fibrosis

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
100 (estimated)
First submitted
6 Jan 2023
Start date
28 Dec 2022
Primary completion date
31 Dec 2027
Lead sponsor
University of North Carolina, Chapel Hill
NCT number
NCT05686837

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 28 Dec 2022 to the primary completion date, 31 Dec 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • No diagnosis of CF

Who the study is looking for

  • 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.

Age in the registry: 1 month to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dell Children's Ascension
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Johns Hopkins Cystic Fibrosis Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
UVA Health University Medical Center
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
The University of Vermont Medical Center
Coordinator of this site? Confirm its status
ColchesterUnited StatesUnknown status
UT Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
National Jewish Health
Coordinator of this site? Confirm its status
DenverUnited StatesUnknown status
UW Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.