Status:
UNKNOWN
Epidemiology of MDR-TB in Peru
Lead Sponsor:
Harvard University Faculty of Medicine
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Brigham and Women's Hospital
Conditions:
TB Multi-drug Resistant
Eligibility:
All Genders
Brief Summary
The purpose of this study is to better understand tuberculosis (TB) and the risk of infection with TB, in Peru. TB is a disease that is caused by bacteria and transmitted through droplets in the air t...
Detailed Description
The emergence of drug-resistant and multi-drug resistant Mycobacterium (M) tuberculosis poses a significant threat to global tuberculosis (TB) control strategies. The prospective design of this study ...
Eligibility Criteria
Inclusion
- TB index subjects
- During the enrollment period, the participant is found to have characteristic acid-fast bacilli shown by the Ziehl-Neelsen stain on a smear of sputum indicating active disease due to M. tuberculosis.
- Participant is at least 16 years old at the time of enrollment.
- Participant lives in one of the study districts.
- If age 18 years or older, participant provides informed consent to participate. If age 16 or 17 years, a guardian provides informed consent for minor to participate, and the minor also provides assent.
- Household members
- Participant lives in the same household as an index subject at the time the index subject is enrolled in the study.
- If eligible participant is age 18 years or older, participant provides informed consent to participate. If participant is younger than 18 years, a parent or guardian provides informed consent for minor to participate. If eligible participant is age 10-17 years, the minor also provides assent.
Exclusion
- Apart from the age restriction (age 16 years and older) for the group of TB index subjects, no other exclusion criteria apply.
- Previous diagnosis with TB disease will not be considered a reason for exclusion from the study.
- Pregnant or breast-feeding women will be eligible to participate in the study.
- Prior to beginning routine TB treatment, health center workers provide women with routine counseling about the use of contraceptive methods during TB treatment; this is not a study activity.
- Subjects who live alone will be included in the study and will contribute to addressing the third and fourth study objectives.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
18544 Patients enrolled
Trial Details
Trial ID
NCT00676754
Start Date
September 1 2009
End Date
September 1 2014
Last Update
March 29 2013
Active Locations (1)
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1
Socios En Salud Sucursal Peru
Lima, Peru, Lima 6