Biomarker Test for Diagnosis and Monitoring of Extrapulmonary Tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study conducted at Kenyatta National Hospital and Mbagathi County Referral Hospital in Nairobi, Kenya, led by Nagasaki University. It aims to identify and evaluate biomarkers, such as lipoarabinomannan, to improve diagnosis and monitoring of extrapulmonary TB in a resource-limited setting. Adults with clinically suspected active extrapulmonary TB, with or without HIV, will provide samples from affected sites for biomarker analysis. The study does not describe any interventions and will observe biomarker performance in real-world clinical specimens to inform future diagnostic approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years and above
* Clinically suspected active EPTB assessed by study clinicians
* Patients with HIV with and without HIV infection
* Patients whose samples can be collected from affected sites (such as lymph node aspirations and biopsies, pleural aspirations, and cerebral spinal fluid aspiration according to type of EPTB suspected)
* Informed consent from patient

Exclusion Criteria:

* Pregnant women: Due to complexities in follow-ups and obtaining samples
* Patient with any type of cancer who is given anti-cancer treatment within the last one year or who has undergone surgery for cancer within the last one year
* Patient who is taking immunosuppressive medications within the last one year: To minimize the impact medication-induced immune responses on TB disease progression and the accuracy of biomarker measurements
* Patient who has anuria or oliguria and unable to provide 30-50ml of urine
* Given TB treatment within one year: To avoid confounding effects from recent therapy
* Patient who is mentally unstable

Where it's running

• Kenyatta National Hospital
  Nairobi, Kenya Recruiting
• Mbagathi County Referral Hospital
  Nairobi, Kenya Recruiting

Study contacts

• Study coordinator: Nobuo Saito, MD, PhD
• Email: nsaito@nagasaki-u.ac.jp
• Phone: +2540773406090

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Doxycycline added to standard treatment for central nervous system tuberculosis

  This trial tests whether adding doxycycline to standard anti‑TB therapy and corticosteroids helps adults with central nervous system tuberculosis live longer or have less severe neurological disability.

  Recruiting at 5 sites Phase 2 National University Hospital, Singapore · Medan, Medan and 5 other locations · NCT06446245

• Shortened treatment for tuberculosis in children

  This study is testing if a shorter 2-month treatment for tuberculosis works just as well and is safe for children under 10 as the usual 4- to 6-month treatment.

  Recruiting at 9 sites Phase 3 Johns Hopkins University · Chennai and 8 other locations · NCT06253715

• Improving tuberculosis diagnosis in Swiss children

  This study is testing new blood tests to see if they can better diagnose tuberculosis in children compared to current methods.

  Recruiting at 8 sites University Children's Hospital Basel · Aarau and 7 other locations · NCT03044509

• Short-Course TB Treatment for Children with Non-Severe Pulmonary TB

  This trial tests two shorter-treatment options for kids with non-severe pulmonary TB to see if they can clear the infection as well as the standard 6-month plan.

  Recruiting at 13 sites Phase 2 Huashan Hospital · Fuzhou, Fujian and 12 other locations · NCT07893444

• Combined oral contraceptive timing with Ganfeborole in healthy women

  This study tests how the contraceptive Microgynon behaves in the body when given alone and with Ganfeborole in healthy women who can’t get pregnant.

  Recruiting Phase 1 GlaxoSmithKline · Madrid · NCT07784894

• Isoniazid inhalation in TB patients: a first-in-human look at local tolerability and body levels

  This early study tests inhaled isoniazid to see how well it tolerates the lungs and how it behaves in the body in adults with tuberculosis.

  Recruiting Phase 1 University Medical Center Groningen · Groningen · NCT07708779

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.