Mycobacterium Infections, NontuberculousNCT02355015
A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections
An observational study of Mycobacterium Infections, Nontuberculous, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The study aims to address the following aims 1. To provide an overview of the epidemiology of the patients who are managed in the Singapore General Hospital for NTM infections. 2. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mycobacterium Infections, Nontuberculous
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2014to Dec 2020
- How long will I take part?
- 5 Years
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients diagnosed with NTM infection in the institution
Who may be able to join
- All patients diagnosed with Nontuberculous Mycobacteria infections.
Who cannot join
- Patient refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, Singapore, 169856
About this study
The study aims to address the following aims
- To provide an overview of the epidemiology of the patients who are managed in the Singapore General Hospital for NTM infections.
- To evaluate the medical care of patients in the institution with regards to the type of medical and/or surgical treatment received and specifically, the antibiotic regime and duration administered.
- A longitudinal follow up which will allow an assessment of our care and patient outcome in this population cohort
Read the detailed description
Nontuberculous Mycobacteria (NTM) is difficult to treat and has no standardised antibiotic therapy. There have been increasing recognition of the need for measurements of NTM care around the world, as rates of NTM infections have begun to supercede Tuberculosis infections for the first time. As health care-associated NTM outbreaks also pose an infection control risk for patients undergoing surgery, this study provides a platform for further greater uniformity and opportunities for improvement in care. (1,2)
Singapore General Hospital (SGH) is a tertiary hospital and sees patients of various complex medical illnesses. Patients with Nontuberculous Mycobacteria (NTM) infections are also on follow up with the infectious diseases specialists SGH. The care of NTM patients can last many years, with patients requiring multiple admissions for reinfections/relapses and are often on long term suppressive therapy and follow up at the Specialist Outpatient Clinic. (3,4)The lack of standardised care for NTM patients, lengthy treatment time for NTM infections, as well as increases in macrolide-resistant NTM infections, warrants a need for research into the epidemiology and best practice to treat this group of patients. (5,6) We seek to better define the epidemiology of this group of patients and hope to objectively measure the effectiveness and quality of our NTM care delivery in SGH.
Currently there is a lack of a systematic database to track our quality of care and support services. As there are many Infectious Diseases Specialists in the department, each may have slight variation in clinical practice and preference in the face of a lack of proper treatment guideline. We believe NTM management can be improved with a consistent care delivery pathway and more standardization of therapy and follow up plan. This will lead to better desired patient outcome. This prospective observational data collection will allow us to evaluate our current standard of care for these patients, which can lead to identification for areas of improvement so that we can refine our strategies and implement more effective and standardized guidelines in the future.
- Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K. An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases. Am J Respir Crit Care Med 2007; Feb 15;175(4):367-416
- Cook JL. Nontuberculous mycobacteria: opportunistic environmental pathogens for predisposed hosts. Br Med Bull 2010;96:45-59
- Piersimoni C. Nontuberculous mycobacteria infection in solid organ transplant recipients. European Journal of Clinical Microbiology \& Infectious Diseases 2012 Apr;31(4):397-403
- Payen MC, De Wit S, Clumeck N. Manifestations, diagnosis and treatment of non-tuberculous mycobacterial infections in patients with HIV infection. Revue des Maladies Respiratoires 1997 Dec;14 Suppl 5:S142-51
- Russell CD, Claxton P, Doig C, Seagar AL, Rayner A, Laurenson IF. Non-tuberculous mycobacteria: a retrospective review of Scottish isolates from 2000 to 2010. Thorax 2013 [Epub ahead of print]
- Binder AM, Adjemian J, Olivier KN, Prevots DR. Epidemiology of Nontuberculous Mycobacterial Infections and Associated Chronic Macrolide Use among Persons with Cystic Fibrosis. American Journal of Respiratory and Critical Care Medicine 2013; [Epub ahead of print]
- Conditions
- Mycobacterium Infections, Nontuberculous
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Patients will be followed up on an outpatient basis and mortality outcomes (all cause) at 6 months, 1 year and 5 years will be monitored.
Measured: 5 years
Secondary outcomes (3)
Clinical response
Managing clinician will judge the clinical response post-induction and post-maintenance treatment. Responses classified as resolved, improved, stable or worse.
Measured: 6 months from start of treatment
Microbiological response
This is specifically for NTM infections involving the lung. Sputum samples will be collected regularly in the 6 month period to document clearance of NTM growth from the sputum. A microbiological response would be classified as 2-3 negative consecutive sputum cultures in the 6 month period.
Measured: 6 months from start of treatment
Chest Xray changes
This is specifically for NTM infections involving the lung. Chest Xray post completion of treatment will be assess and classified as resolved, improved, stable or worse.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Infections, NontuberculousStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Dr Cherng, MBBS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355015
- Sponsor's protocol ID
- 2014/205/F
- Status last verified
- Feb 2017
- First submitted
- 28 Jan 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections
- ClinicalTrials.gov ID
- NCT02355015
- Acronym / sponsor ID
- 2014/205/F
- Conditions
- Mycobacterium Infections, Nontuberculous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Feb 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.
The study aims to address the following aims
- To provide an overview of the epidemiology of the patients who are managed in the Singapore General Hospital for NTM infections.
- To evaluate the medical care of patients in the institution with regards to the type of medical and/or surgical treatment received and specifically, the antibiotic regime and duration administered.
- A longitudinal follow up which will allow an assessment of our care and patient outcome in this population cohort
Detailed description
Nontuberculous Mycobacteria (NTM) is difficult to treat and has no standardised antibiotic therapy. There have been increasing recognition of the need for measurements of NTM care around the world, as rates of NTM infections have begun to supercede Tuberculosis infections for the first time. As health care-associated NTM outbreaks also pose an infection control risk for patients undergoing surgery, this study provides a platform for further greater uniformity and opportunities for improvement in care. (1,2)
Singapore General Hospital (SGH) is a tertiary hospital and sees patients of various complex medical illnesses. Patients with Nontuberculous Mycobacteria (NTM) infections are also on follow up with the infectious diseases specialists SGH. The care of NTM patients can last many years, with patients requiring multiple admissions for reinfections/relapses and are often on long term suppressive therapy and follow up at the Specialist Outpatient Clinic. (3,4)The lack of standardised care for NTM patients, lengthy treatment time for NTM infections, as well as increases in macrolide-resistant NTM infections, warrants a need for research into the epidemiology and best practice to treat this group of patients. (5,6) We seek to better define the epidemiology of this group of patients and hope to objectively measure the effectiveness and quality of our NTM care delivery in SGH.
Currently there is a lack of a systematic database to track our quality of care and support services. As there are many Infectious Diseases Specialists in the department, each may have slight variation in clinical practice and preference in the face of a lack of proper treatment guideline. We believe NTM management can be improved with a consistent care delivery pathway and more standardization of therapy and follow up plan. This will lead to better desired patient outcome. This prospective observational data collection will allow us to evaluate our current standard of care for these patients, which can lead to identification for areas of improvement so that we can refine our strategies and implement more effective and standardized guidelines in the future.
- Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K. An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases. Am J Respir Crit Care Med 2007; Feb 15;175(4):367-416
- Cook JL. Nontuberculous mycobacteria: opportunistic environmental pathogens for predisposed hosts. Br Med Bull 2010;96:45-59
- Piersimoni C. Nontuberculous mycobacteria infection in solid organ transplant recipients. European Journal of Clinical Microbiology \& Infectious Diseases 2012 Apr;31(4):397-403
- Payen MC, De Wit S, Clumeck N. Manifestations, diagnosis and treatment of non-tuberculous mycobacterial infections in patients with HIV infection. Revue des Maladies Respiratoires 1997 Dec;14 Suppl 5:S142-51
- Russell CD, Claxton P, Doig C, Seagar AL, Rayner A, Laurenson IF. Non-tuberculous mycobacteria: a retrospective review of Scottish isolates from 2000 to 2010. Thorax 2013 [Epub ahead of print]
- Binder AM, Adjemian J, Olivier KN, Prevots DR. Epidemiology of Nontuberculous Mycobacterial Infections and Associated Chronic Macrolide Use among Persons with Cystic Fibrosis. American Journal of Respiratory and Critical Care Medicine 2013; [Epub ahead of print]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with NTM infection in the institution
Key inclusion criteria (1 listed)
- All patients diagnosed with Nontuberculous Mycobacteria infections.
Key exclusion criteria (1 listed)
- Patient refusal to participate in the study
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
All cause mortality
Time frame: 5 years
Patients will be followed up on an outpatient basis and mortality outcomes (all cause) at 6 months, 1 year and 5 years will be monitored.
3 secondary outcomes
Clinical response
Time frame: 6 months from start of treatment
Microbiological response
Time frame: 6 months from start of treatment
Chest Xray changes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Benjamin Dr Cherng, MBBS principal investigator
Singapore General Hospital
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 Mycobacterium Infections, Nontuberculous, run by Singapore General Hospital at 1 site in Singapore.
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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Cherng (63213479, benjamin.cherng.p.z@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 5 years). 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 23 Feb 2017.