NCT02355015

Brief Summary

The study aims to address the following aims

  1. 1.To provide an overview of the epidemiology of the patients who are managed in the Singapore General Hospital for NTM infections.
  2. 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. 3.A longitudinal follow up which will allow an assessment of our care and patient outcome in this population cohort

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6.8 years

First QC Date

January 28, 2015

Last Update Submit

February 20, 2017

Conditions

Mycobacterium Infections, Nontuberculous

Outcome Measures

Primary Outcomes (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.

    5 years

Secondary Outcomes (3)

  • Clinical response

    6 months from start of treatment

  • Microbiological response

    6 months from start of treatment

  • Chest Xray changes

    6 months

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with NTM infection in the institution

You may qualify if:

  • All patients diagnosed with Nontuberculous Mycobacteria infections.

You may not qualify if:

  • Patient refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 169856, Singapore

RECRUITING

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Benjamin Dr Cherng, MBBS

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Cherng

CONTACT

63213479benjamin.cherng.p.z@sgh.com.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 4, 2015

Study Start

March 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

SG(1)