NCT00367913

Brief Summary

To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active in vitro against these species of mycobacteria. The primary aim of this study was to compare these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess the vale of immunotherapy with M.vaccae.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 1995

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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, 1995

Completed
9.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
Last Updated

August 23, 2006

Status Verified

July 1, 2006

First QC Date

August 21, 2006

Last Update Submit

August 21, 2006

Conditions

Pulmonary Diseases

Keywords

pulmonary diseaseTreatment of Opportunist MycobacteriaClarithromycinCiprofloxacinM.vaccaePulmonary diseases caused by Opportunist Mycobacteria

Outcome Measures

Primary Outcomes (4)

  • Death rates

  • Cure rates

  • Relapse rates

  • Unwanted effects of therapy

Secondary Outcomes (1)

  • Benefit or not of immunotherapy with M.vaccae

Interventions

Addition of clarithromycin to rifampicin and ethambutolDRUG
Addition of Ciprofloxacin to rifampicin and ethambutolDRUG
Vaccination with M.vaccaeBIOLOGICAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pulmonary disease due to M.avium intracellulare, M.malmoense or M.xenopi. Aged 16 or over. With clinical and/or radiological evidence of active infection and producing sputum positive on culture on at least 2 occasions.

You may not qualify if:

  • Pregnant women and women of childbearing age not taking adequate contraceptive precautions.
  • Patients who have sputum currently positive on culture for M.tuberculosis or M.bovis.
  • Patients who have AIDS or who are known to be HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Llandough Hospital

Penarth, Vale of Glamorgan, CF64 2XX, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

EthambutolVaccination

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsImmunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Ian Campbell, BSc MD FRCP

    British Thoracic Society, Research Committee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 23, 2006

Study Start

March 1, 1995

Study Completion

September 1, 2004

Last Updated

August 23, 2006

Record last verified: 2006-07

Locations

GB(1)