Epidemiology of MDR-TB in Peru

NCT00676754 | Unknown

• 3 other identifiers: 07-00025U19AI076217R01AI057786
• Study Type: observational
• Target: 18,544
• Locations: 1 country
• Sites: 1

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 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.

Conditions

TB Multi-drug Resistant

Keywords

Multidrug-Resistant Tuberculosis, tuberculosis, Peru

Outcome Measures

Primary Outcomes (1)

• Risk of TB infection among the household members

  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.

  at months 6 and 12 after study enrollment

Other Outcomes (1)

• 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.

  24-month period after completing TB drug therapy

Interventions

Statens Serum Institut RT23 2TU tuberculin PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard University Faculty of Medicine: lead
• Harvard School of Public Health (HSPH): collaborator
• Brigham and Women's Hospital: collaborator
• Socios En Salud Sucursal, Peru: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Socios En Salud Sucursal Peru

Lima, Lima 6, Peru

Location

Related Publications (1)

• 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.

  PMID: 31649017 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, sputum

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Megan Murray, MD, ScD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Global Health and Social Medicine

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: September 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

PE (1)