NCT00814827Active, not recruiting

Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma

Mycobacterial and Opportunistic Infections in HIV-Negative Patients Associated With Autoantibodies to Interferon-gamma

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Observational
Enrollment: 224 (actual)
First submitted: 24 Dec 2008
Start date: 7 Jan 2010
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Diseases: Tuberculosis
NCT number: NCT00814827

What you commit to

Study type: Observational
Participants enrolled: 224
5 sites in 3 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Subjects cannot be receiving any other investigational study agents when enrolling on this study.

Other illness

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

Age less than 18 years

Other

Patients will be excluded for the following reasons:

Criteria the registry did not label

INCLUSION CRITERIA:
- Patients must meet all of the following criteria at the time of evaluation to be eligible for enrollment into the study cohorts:
- Group 1 (NTM alone):
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
- Group 2 (non-NTM OI with or without NTM):
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).
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 diagnosis
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
- Group 3 (diseased control with pulmonary MTB):
Active pulmonary MTB, i.e. patients who have sputum that is either culture positive for MTB or AFB positive and responding to therapy for MTB.
Diagnosed within the past 6 months.
No concurrent infections due to NTM or OI listed under above inclusion criteria for study subjects
No clinical evidence of HIV
- Group 4 (diseased control with disseminated MTB):
- Disseminated MTB includes infections involving greater than or equal to 2 noncontiguous sites, one of which may include pulmonary disease or greater than or equal to 2 separate groups of lymph nodes.
Active disseminated MTB or cured disseminated MTB
No concurrent infections due to NTM or OI listed under above inclusion criteria for study subjects
HIV negative within 3 months either prior to the diagnosis of MTB, or prior to enrollment in this study, if HIV status was unknown at the time of MTB diagnosis
No evidence of active malignancy
No systemic corticosteroids at time of diagnosis of OI (defined as \> 4 weeks at a dose \> 10 mg per day of prednisone within 3 months prior to diagnosis of the NTM)
No preexisting immune deficiency.
- Group 5 (Blood Specimen Donor):
- Eligibility criteria not applicable. Blood will be collected from volunteers, and no medical evaluation will be performed.
- To be a blood donor the person cannot be excluded per these exclusionary criteria: Patient cannot be less that 18 or more than 85, Patient must not weigh less than 45 KG (99 Lbs), Patient cannot be receiving chemotherapy or have cancer, Patient cannot be receiving any immunosuppressant medications, Patient cannot have a history of heart, lung, kidney disease or bleeding disorder.
- Samples will be collected from anyone of the collaborating sites. Immediately after drawing a specimen it will be assigned a number that is unlinked to the person donating. Thus, they will be anonymous and not traceable back to the original volunteer. Subjects will be consented and compensated for their contribution.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Taiwan University Coordinator of this site? Confirm its status	Taiwan	China	Unknown status
Ramathibodi Hospital, Mahidol Universtiy Coordinator of this site? Confirm its status	Bangkok	Thailand	Unknown status
National Siriraj Hospital, Mahidol Universtiy Coordinator of this site? Confirm its status	Bangkok	Thailand	Unknown status
Srinagarind Hospital Coordinator of this site? Confirm its status	Khon Kaen	Thailand	Unknown status
National Cheng Kung University Coordinator of this site? Confirm its status	Tainan	Taiwan	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.