- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00676754
Epidemiology of MDR-TB in Peru (Estudio Epi)
Epidemiology of Multidrug-Resistant Tuberculosis in Peru
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Lima, Peru, Lima 6
- Socios En Salud Sucursal Peru
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study population includes two categories of subjects: (1) the 4,000 TB index subjects and (2) their approximately 18,000 household members. All of these individuals live in Lima, Peru, in the catchment area of the participating public health centers.
Approximately 50% of study participants will be female. According to the ethnic and racial categories used by NIH, all of the study population would be classified as "Hispanic or Latino" (Mestizo). None of these participants live within a tribal indigenous culture; all speak Spanish while some also speak the indigenous (Quechua) language of their birthplace in Peru. At least 75% of this population has some "Amerindian" heritage. Less than 1% of individuals are either Asian-Peruvian or Afro-Peruvian in descent.
Apart from the age restriction (at least 16 years old) for the TB index subjects only, there are no other restrictions on participant selection
Description
Inclusion Criteria:
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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Risk of TB infection among the household members
Time Frame: at months 6 and 12 after study enrollment
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at months 6 and 12 after study enrollment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative risk of specific DR mutations in index case across household contacts who acquire TB from strain matching the index case strain, vs. disease-free contacts; and cases whose contacts do/do not convert from negative to positive PPD skin test.
Time Frame: at months 6 and 12 after study enrollment
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at months 6 and 12 after study enrollment
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative risk of relapse and reinfection in index patients who are sick with drug-resistant M. tuberculosis strains compared to index patients sick with drug-sensitive strains.
Time Frame: 24-month period after completing TB drug therapy
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24-month period after completing TB drug therapy
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Megan Murray, MD, ScD, Harvard Medical School (HMS and HSDM)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-0002
- 5U19AI076217 (U.S. NIH Grant/Contract)
- R01AI057786 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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