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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Singapore General Hospital

    Singapore, Singapore, 169856

    Recruiting

Other trials in Singapore

About this study

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. 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.
  3. 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.

  1. 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
  2. Cook JL. Nontuberculous mycobacteria: opportunistic environmental pathogens for predisposed hosts. Br Med Bull 2010;96:45-59
  3. Piersimoni C. Nontuberculous mycobacteria infection in solid organ transplant recipients. European Journal of Clinical Microbiology \& Infectious Diseases 2012 Apr;31(4):397-403
  4. 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
  5. 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]
  6. 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]
Medical subject headings
Mycobacterium Infections, Nontuberculous

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted4 Feb 2015 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
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

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.

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