A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections

• ClinicalTrials.gov Identifier: NCT02355015
• Recruitment Status: Unknown
• First Posted: February 4, 2015
• Last Update Posted: February 23, 2017
• Sponsor: Singapore General Hospital
• Information provided by (Responsible Party): Singapore General Hospital

Tracking Information

• First Submitted Date: January 28, 2015
• First Posted Date: February 4, 2015
• Last Update Posted Date: February 23, 2017
• Study Start Date: March 2014
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2015)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 2, 2015)

• Clinical response [ Time Frame: 6 months from start of treatment ]
  Managing clinician will judge the clinical response post-induction and post-maintenance treatment. Responses classified as resolved, improved, stable or worse.
• Microbiological response [ Time Frame: 6 months from start of treatment ]
  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.
• Chest Xray changes [ Time Frame: 6 months ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections
• Official Title: A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections

Brief 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. 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

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]

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All patients diagnosed with NTM infection in the institution
• Condition: Mycobacterium Infections, Nontuberculous
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 2, 2015): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All patients diagnosed with Nontuberculous Mycobacteria infections.

Exclusion Criteria:

• Patient refusal to participate in the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT02355015
• Other Study ID Numbers: 2014/205/F
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Singapore General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Singapore General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Benjamin Dr Cherng, MBBS; Singapore General Hospital

• PRS Account: Singapore General Hospital
• Verification Date: February 2017