TB Multi-drug ResistantEstudio EpiNCT00676754
Epidemiology of MDR-TB in Peru
An observational study of TB Multi-drug Resistant, run by Harvard University Faculty of Medicine at 1 site in Peru.
Trial 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 that come from the lungs of an infected person. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- TB Multi-drug Resistant
- What is being tested?
- Statens Serum Institut RT23 2TU tuberculin
- Type of treatment
- Surgery or procedure
- How many people
- 18,544 participants
- Where
- 1 sitePeru
- Study dates
- Sep 2009to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of Multidrug-Resistant Tuberculosis in Peru
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 that come from the lungs of an infected person. The risk of infection will be compared between two groups: household members, who live with people having TB that does not respond well to treatment and household members, who live with people having TB that responds well to treatment. Study participants will include 4,500 TB infected people and 22,500 of their household contacts. Study procedures include answering a questionnaire, TB skin tests, blood samples, and a chest x-ray. Individuals with symptoms indicating TB will be asked to provide sputum samples. Individuals with TB will be involved in the study for up to 48 months; household contacts will be involved in the study for 12 months. The knowledge gained from this study will be used to improve tuberculosis control.
Read the 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 will allow the direct study of infection risk, because the population among which the TB cases arise will be identified and monitored over the course of the study. This study design will permit the characterization and comparison of TB strains with differential success in causing new infections. The study will be conducted within a well-established public health TB control program in a region of Peru, where drug-resistant strains already account for about 20 percent of new TB cases. This study protocol will be implemented in collaboration with the 52 Ministry of Health outpatient health centers in 4 districts of Lima, Peru. This will be a prospective cohort study with an enrollment period of 36 consecutive months. Two types of study subjects will be enrolled: patients found to have active TB disease by routine testing (TB index subjects), and the individuals living in the households of these patients (household members). Study participants will include 4,500 subjects with active TB and their approximately 22,500 household members. Ages will range from less than 1-100 years. The tuberculin skin test will be used to diagnose latent TB infection in the household members. This product is used routinely by health center staff in household members who are children in the age group less than1-15 years. In this study protocol, it will also be used in all household members age 16 years and older. Each TB index subject will remain in the study for a minimum of 12 months and a maximum 48 months. Each household member will remain in the study for 12 months. The primary objective of the study is to measure the risk of infection in household members of index cases with drug-resistant TB compared with the risk of infection in household members of subjects with drug-sensitive TB. This refers to household members who are tuberculin-skin-test negative at the beginning of follow-up. Secondary study objectives are: to assess the impact of sociodemographic and clinical confounders and risk modifiers such as age, sex, comorbidity, human immunodeficiency virus (HIV) infection, nutritional status, and Bacille Calmette Guerin (BCG) vaccination on the association between risk of infection and exposure to a drug-resistant or a drug-sensitive strain; to measure associations between specific mutations associated with drug resistance in M tuberculosis and phenotypes including resistance profile, clinical presentations, and transmissibility; to measure the rate of true relapse versus reinfection in drug-resistant and drug-sensitive TB subjects using molecular-epidemiologic methods; and to measure the rate of reversion (to negative) of the tuberculin skin test among household members with a positive tuberculin skin test result. The primary study outcome measure is the relative risk of TB infection (by tuberculin skin test) in household members of subjects who are sick with drug-resistant M tuberculosis strains compared to household members of subjects with drug-sensitive strains. Secondary study outcome measures are the rate of relapse and rate of reinfection among TB subjects treated with routine TB therapy by outpatient health centers; and the rate of reversion (to negative) of the tuberculin skin test among household members with a positive tuberculin skin test result.
- Conditions
- TB Multi-drug Resistant
- Being tested
- Statens Serum Institut RT23 2TU tuberculin
- Keywords
- Multidrug-Resistant Tuberculosis, tuberculosis, Peru
- Medical subject headings
- Tuberculosis, Multidrug-Resistant, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statens Serum Institut RT23 2TU tuberculinProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of TB infection among the household members
Measured: at months 6 and 12 after study enrollment
Secondary outcomes (1)
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.
Measured: at months 6 and 12 after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startSep 2009
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TB Multi-drug ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18,544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Brigham and Women's Hospital, Socios En Salud Sucursal, Peru, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Mercedes Becerra, Harvard University Faculty of Medicine
- Investigators
- Megan Murray, MD, ScD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676754
- Sponsor's protocol ID
- 07-0002
- Other IDs
- 5U19AI076217, R01AI057786
- Acronym
- Estudio Epi
- Status last verified
- Mar 2013
- First submitted
- 8 May 2008
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Becerra MC, Huang CC, Lecca L, Bayona J, Contreras C, Calderon R, Yataco R, Galea J, Zhang Z, Atwood S, Cohen T, Mitnick CD, Farmer P, Murray M. Transmissibility and potential for disease progression of drug resistant Mycobacterium tuberculosis: prospective cohort study. BMJ. 2019 Oct 24;367:l5894. doi: 10.1136/bmj.l5894.
PubMed 31649017
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Multidrug-Resistant Tuberculosis in Peru
- ClinicalTrials.gov ID
- NCT00676754
- Acronym / sponsor ID
- Estudio Epi / 07-0002
- Conditions
- TB Multi-drug Resistant
- Keywords
- Multidrug-Resistant Tuberculosis, tuberculosis, Peru
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,544 participants (actual)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Brigham and Women's Hospital, Socios En Salud Sucursal, Peru, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2009
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 13 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 that come from the lungs of an infected person. The risk of infection will be compared between two groups: household members, who live with people having TB that does not respond well to treatment and household members, who live with people having TB that responds well to treatment. Study participants will include 4,500 TB infected people and 22,500 of their household contacts. Study procedures include answering a questionnaire, TB skin tests, blood samples, and a chest x-ray. Individuals with symptoms indicating TB will be asked to provide sputum samples. Individuals with TB will be involved in the study for up to 48 months; household contacts will be involved in the study for 12 months. The knowledge gained from this study will be used to improve tuberculosis control.
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 will allow the direct study of infection risk, because the population among which the TB cases arise will be identified and monitored over the course of the study. This study design will permit the characterization and comparison of TB strains with differential success in causing new infections. The study will be conducted within a well-established public health TB control program in a region of Peru, where drug-resistant strains already account for about 20 percent of new TB cases. This study protocol will be implemented in collaboration with the 52 Ministry of Health outpatient health centers in 4 districts of Lima, Peru. This will be a prospective cohort study with an enrollment period of 36 consecutive months. Two types of study subjects will be enrolled: patients found to have active TB disease by routine testing (TB index subjects), and the individuals living in the households of these patients (household members). Study participants will include 4,500 subjects with active TB and their approximately 22,500 household members. Ages will range from less than 1-100 years. The tuberculin skin test will be used to diagnose latent TB infection in the household members. This product is used routinely by health center staff in household members who are children in the age group less than1-15 years. In this study protocol, it will also be used in all household members age 16 years and older. Each TB index subject will remain in the study for a minimum of 12 months and a maximum 48 months. Each household member will remain in the study for 12 months. The primary objective of the study is to measure the risk of infection in household members of index cases with drug-resistant TB compared with the risk of infection in household members of subjects with drug-sensitive TB. This refers to household members who are tuberculin-skin-test negative at the beginning of follow-up. Secondary study objectives are: to assess the impact of sociodemographic and clinical confounders and risk modifiers such as age, sex, comorbidity, human immunodeficiency virus (HIV) infection, nutritional status, and Bacille Calmette Guerin (BCG) vaccination on the association between risk of infection and exposure to a drug-resistant or a drug-sensitive strain; to measure associations between specific mutations associated with drug resistance in M tuberculosis and phenotypes including resistance profile, clinical presentations, and transmissibility; to measure the rate of true relapse versus reinfection in drug-resistant and drug-sensitive TB subjects using molecular-epidemiologic methods; and to measure the rate of reversion (to negative) of the tuberculin skin test among household members with a positive tuberculin skin test result. The primary study outcome measure is the relative risk of TB infection (by tuberculin skin test) in household members of subjects who are sick with drug-resistant M tuberculosis strains compared to household members of subjects with drug-sensitive strains. Secondary study outcome measures are the rate of relapse and rate of reinfection among TB subjects treated with routine TB therapy by outpatient health centers; and the rate of reversion (to negative) of the tuberculin skin test among household members with a positive tuberculin skin test result.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statens Serum Institut RT23 2TU tuberculin | Procedure or surgery | – |
Primary outcome
Risk of TB infection among the household members
Time frame: at months 6 and 12 after study enrollment
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Derived from this study: PubMed 31649017Becerra MC, Huang CC, Lecca L, Bayona J, Contreras C, Calderon R, Yataco R, Galea J, Zhang Z, Atwood S, Cohen T, Mitnick CD, Farmer P, Murray M. Transmissibility and potential for disease progression of drug resistant Mycobacterium tuberculosis: prospective cohort study. BMJ. 2019 Oct 24;367:l5894. doi: 10.1136/bmj.l5894.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Murray, MD, ScD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TB Multi-drug Resistant, run by Harvard University Faculty of Medicine at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of TB infection among the household members (time frame: at months 6 and 12 after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.