Mystery infections in healthy people: scientists investigate
NCT ID NCT00814827
First seen Jun 26, 2026 · Last updated Jul 17, 2026 · Updated 9 times
Summary
This study looks at HIV-negative people who get opportunistic infections—illnesses that usually only affect those with weak immune systems. Researchers want to find out if these patients have unusual antibodies that block a key immune signal. Up to 224 adults in Thailand and Taiwan will be followed for two years to understand why their bodies can't fight off certain germs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this research could help identify why some otherwise healthy people get serious infections, potentially leading to better diagnosis or targeted treatments.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly lead to new therapies, and findings may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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224 people
The number who actually took part.
- Started
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Jan 2010
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This is a prospective natural history cohort study with a case-control component. Patients will be recruited from 5 groups: 1) subjects with NTM alone, 2) subjects with a non-NTM OI, either with or without concurrent NTM infection, 3) subjects with pulmonary MTB, 4) subjects with disseminated MTB, and 5) Blood Specimen Donor controls.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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): 1. 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. 2. NTM is not felt to be iatrogenic (such as indwelling catheter associated or post-operative wound infection) 3. 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 4. No evidence of active malignancy 5. 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) 6. No preexisting immune deficiency Group 2 (non-NTM OI with or without NTM): 1. 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. 2. Patient may have infection with NTM in addition to one or more of the above infection(s). 3. 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 4. No evidence of active malignancy 5. 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) 6. No preexisting immune deficiency Group 3 (diseased control with pulmonary MTB): 1. 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. 2. Diagnosed within the past 6 months. 3. No concurrent infections due to NTM or OI listed under above inclusion criteria for study subjects 4. 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. 1. Active disseminated MTB or cured disseminated MTB 2. No concurrent infections due to NTM or OI listed under above inclusion criteria for study subjects 3. 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 4. No evidence of active malignancy 5. 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) 6. 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. EXCLUSION CRITERIA: Patients will be excluded for the following reasons: 1. HIV-positive serostatus for groups 1, 2 and 4 (groups 3 and 5 we will not be routinely performing HIV testing) 2. Active malignancy 3. Medical conditions requiring immune modulating therapy (i.e. corticosteroids, biological agents, anti-metabolites) and /or chemotherapy 4. Any other medical conditions unsuitable for this study as determined by the principal investigator 5. Age less than 18 years 6. Subjects cannot be receiving any other investigational study agents when enrolling on this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Cheng Kung University
Tainan, Taiwan
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National Siriraj Hospital, Mahidol Universtiy
Bangkok, Thailand
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National Taiwan University
Taiwan, China
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Ramathibodi Hospital, Mahidol Universtiy
Bangkok, Thailand
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Srinagarind Hospital
Khon Kaen, 40002, Thailand
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Other studies related to the condition(s) this trial covers.
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