Sponsor study identifier
interventional
924
1 country
1
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2006
Actual (reported)Study Completion
February 2007
Actual (reported)The purpose of the study is whether the provision of tuberculosis care using volunteer community health workers or self-administered treatment for 7 months is equally effective with the existing 8 months of TB care in public health facilities by health workers. Patient care by volunteer community health workers and 7 months of self-administered treatment are more patient-convenient delivery options than the ongoing TB care in health facility.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
December 2006
Actual (reported)February 2007
Actual (reported)July 14, 2009
Actual (reported)July 15, 2009
Actual (reported)Cured and successful completion of treatment of smear positive and smear negative pulmonary tuberculosis cases.
August 2005 to January 2007
Patients received daily tuberculosis care in public health facilities by trained health worker during the first 8 weeks followed by self-treatment for the remaining 6 months. Patients were expected to visit public health facility every month for follow up. Supervisory support was given to TB focal persons by the respective district TB coordinators on a monthly basis. Anti-TB drugs were delivered to health institutions on a quarterly basis by district TB coordinators during supervision
Tigray Regional Health Bureau, Department for Diseases Prevention and Control
Mek'ele, Tigray, 7, Ethiopia
Mesfin MM, Newell JN, Walley JD, Gessessew A, Madeley RJ. Delayed consultation among pulmonary tuberculosis patients: a cross sectional study of 10 DOTS districts of Ethiopia. BMC Public Health. 2009 Feb 9;9:53. doi: 10.1186/1471-2458-9-53.
Mengiste M Mesfin et al. Community-based tuberculosis control interventions in pilot districts of Tigray, Ethiopia: baseline studies Ethiop. J. Health Dev. 2005; 19 (Special Issue): 1-37.
Mengiste M Melese, MD, MPH, PhD
Nuffield Centre for International Health and Development, Institute of Health Sciences, University of Leeds
Madley J Richard, MD
University of Nottingham
924 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2009
First Posted
July 15, 2009
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)
Patients had daily TB care including observation of treatment by the CHWs in their villages for the second month. Thereafter, treatment was self-administered with a monthly follow up visit to a CHW home for the remaining 6 months. Technical support and anti-TB drugs were given to CHWs by the respective public health facility TB health worker every fortnight.
Patients took their medication at home for seven months after one month of daily care in public health facilities by TB health workers. They were taught by the TB health worker to collect their anti-TB drugs fortnightly and report missed daily doses. Follow up assessment and continued support was made by TB health worker on a monthly basis in their nearby health facility.
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Primary Completion
December 2006
Actual (reported)Study Completion
February 2007
Actual (reported)Last Updated
July 16, 2009
Record last verified: 2009-07
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Source: ClinicalTrials.gov.
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