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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Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Past or current infection with NTM proven by culture or specific DNA detection in the presence of a compatible clinical picture as judged by the responsible clinician and PI on site.
. NTM is not felt to be iatrogenic (such as indwelling catheter associated or post-operative wound infection)
. HIV negative within 3 months either prior to the diagnosis of OI, or prior to enrollment in this study, if HIV status was unknown at the time of OI
. No evidence of active malignancy
. No systemic corticosteroids at time of diagnosis of OI (defined as greater than 4 weeks at a dose greater than 10 mg per day of prednisone within 3 months prior to diagnosis of the NTM)
. No preexisting immune deficiency
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on finding anti-interferon-gamma autoantibodies in HIV-negative patients with disseminated nontuberculous mycobacteria or opportunistic infections, could you test me for these autoantibodies, and what would a positive result mean for how my condition is managed?
2This trial is listed as 'active not recruiting,' meaning they're no longer enrolling new participants — so how does the research coming out of this study affect the treatment options you'd consider for me right now?
3The study is specifically enrolling Thai and Taiwanese patients — does my background or where I'm being treated affect whether findings from this research apply to my situation?
4Since this study is observational and focused on identifying a biological marker rather than testing a treatment, what actual therapies exist for people who have these anti-interferon-gamma autoantibodies, and are any of those options available to me?
5Given that my immune system may be responding abnormally even without HIV, what does that mean for my long-term risk of other opportunistic infections, and should I be monitored differently because of that?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: ongoing
Trial details
NCT IDNCT00814827
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Patients must have or have had proven infection with one or more of the following organisms: disseminated Salmonella, Listeria, Penicillium, Burkholderia pseudomallei, Cryptococcus, Histoplasma, Herpes zoster involving 2 or more non-contiguous dermatomes, or extradermal involvement or other opportunistic infections not listed above, but relevant, as determined by the PI.
. Patient may have infection with NTM in addition to one or more of the above infection(s).
Exclusion criteria
. HIV-positive serostatus for groups 1, 2 and 4 (groups 3 and 5 we will not be routinely performing HIV testing)
. Active malignancy
. Medical conditions requiring immune modulating therapy (i.e. corticosteroids, biological agents, anti-metabolites) and /or chemotherapy
. Any other medical conditions unsuitable for this study as determined by the principal investigator
. Age less than 18 years
. Subjects cannot be receiving any other investigational study agents when enrolling on this study.