Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
- Conditions
- Opportunistic InfectionsMycobacterium TuberculosisNontuberculous Mycobacteria
- Registration Number
- NCT00814827
- Brief Summary
Opportunistic infections are caused by bacteria, mycobacteria, fungi or viruses that do not normally cause infections in people with healthy immune systems. Some of these infections can cause public health concerns, especially in areas with limited access to treatment. People who acquire opportunistic infections usually have diseases that affect their immune systems, such as human immunodeficiency virus (HIV), or do not have enough white blood cells to fight the infection. However, some people acquire opportunistic infections even though they have normal amounts of white blood cells and are free from known diseases that harm their immune systems. This study will investigate some of the reasons that otherwise healthy people get opportunistic infections to learn more about why some people are more likely to have them.
This study will include up to 210 HIV-negative males and females older than 18 years of age who have opportunistic infections. The patients will be drawn from multiple sites in Thailand and Taiwan including Khon Kaen University Hospital, Siriraj Hospital, Ramathibodi Hospital, National Taiwan University Hospital, National Cheng-Kung University Hospital
Patients will undergo an initial evaluation that will include a physical examination, medical history, and blood and urine testing. Additional tests will be conducted if the researchers consider that the tests are medically necessary to treat the opportunistic infection; the results of the tests will be reviewed and saved for study purposes. Depending on the severity of the infection, the initial evaluation may take more than 1 day to complete.
After the evaluation, patients will be given standard and appropriate medicines to treat the infections.
Patients will return for follow-up visits to allow researchers to monitor their condition and to assess how well the patient is responding to the treatment. Patients will be evaluated by the study researchers at least once a year for 2 years following the initial treatment.
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- Detailed Description
The acquisition of opportunistic infections has been causally linked to innate and acquired immunodeficiencies. We have recently identified a population of Asian women with autoantibodies to interferon gamma (IFN?), all of whom were diagnosed by virtue of nontuberculous mycobacterial infections. Similar patient populations have been reported from Thailand, and we have found similar autoantibodies in anonymous serum samples from there. In addition, many of the Thai patients who have disseminated or lymphatic nontuberculous infections have had other opportunistic infections (OI), such as salmonella, penicilliosis, and histoplasmosis. However, they have normal lymphocyte counts and are human immunodeficiency virus (HIV) negative. Therefore, the identification of autoantibodies to a critical cytokine, the occurrence of opportunistic infections, and the lack of other common explanations suggests that this is an important population to study. We propose to enroll patients in a natural history study of non-HIV opportunistic infections to explore the presence of autoantibodies to cytokines, and to examine potential immunogenetic factors influencing the development of this disease. Plasma, cells, and DNA samples will be obtained and stored for use in this study. This study will accrue up to 265 patients over 5 years as per the protocol with follow up for 15 years on each patient, sample size justification and the groups described in the protocol.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 224
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of the presence of autoantibodies to IFNy in HIV-negative Thai and Taiwanese patients with disseminated NTM and OI who are followed at the participating institutions. ongoing Compare the baseline prevalence rate of autoantibodies to IFNg, as defined by having \>75% inhibition, in patients with disseminated NTM or other OI (groups 1 and 2) versus normal or diseased controls (groups 3 and 5).
- Secondary Outcome Measures
Name Time Method Identification of predisposing factors for the development of autoimmunity to cytokines and/or their receptors. ongoing Identification of predisposing factors for the development of autoimmunity to cytokines and/or their receptors.
Identification of other autoantibodies that might manifest similarly to patients with autoantibodies to IFNg. ongoing Identification of other autoantibodies.
Characterization of the natural history and specific microbiology in HIV-negative patients with disseminated NTM and other OI and to determine any statistically significant differences from MTB controls or healthy blood bank donors. ongoing Characterization of the natural history and infections of consecutive patients with NTM alone and NTM with other OI. Speciation of the opportunistic infections identified and categorization of these infections with descriptive statistics.
Trial Locations
- Locations (5)
National Taiwan University
🇨🇳Taiwan, China
National Siriraj Hospital, Mahidol Universtiy
🇹🇭Bangkok, Thailand
Ramathibodi Hospital, Mahidol Universtiy
🇹🇭Bangkok, Thailand
National Cheng Kung University
🇨🇳Tainan, Taiwan
Srinagarind Hospital
🇹🇭Khon Kaen, Thailand