Clinical Trial: A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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 Summary:

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
Sponsor: Singapore General Hospital

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Singapore General Hospital

Dates:
Date Received: January 28, 2015
Date Started: March 2014
Date Completion: December 2020
Last Updated: February 20, 2017
Last Verified: February 2017