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New treatment option for Tuberculosis
Official title Shortened Regimen for Drug-susceptible TB in Children
ClinicalTrials.gov ID: NCT06253715
What this study is testing
What is Isoniazid?
Isoniazid is an investigational medicine, given as an once-daily, being studied as a potential treatment for tuberculosis.
Also referred to as H.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 9
You may be able to join if
- Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when...
- At Entry, age of less than 10 years.
- At Entry, weight 3 kilograms (kg) or greater.
- At Entry, diagnosed with TB disease, defined as:
- Pulmonary (including pleural effusion) and/or lymph node (extra-thoracic and/or intra-thoracic) TB with or without bacteriologic confirmation;
You likely can't join if
- Presumed or documented extra-pulmonary TB involving the central nervous system and/or bones and/or joints, and/or miliary TB, and/or pericardial TB...
- Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry.
- Any known contraindication to taking any study drug:
- Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs;
- Any prohibited medications within three days prior to Entry or planned use within the following 6 months;
- Unable to take oral medications;
See the full eligibility criteria
- Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee/Institutional Review Board (EC/IRB) policies...
- At Entry, age of less than 10 years.
- At Entry, weight 3 kilograms (kg) or greater.
- At Entry, diagnosed with TB disease, defined as:
- Pulmonary (including pleural effusion) and/or lymph node (extra-thoracic and/or intra-thoracic) TB with or without bacteriologic confirmation;
- Clinician has decided to treat with standard first-line drug-susceptible TB regimen.
- Known HIV status or HIV testing in progress based on meeting testing requirements.
- Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent):
- Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal;
- Total bilirubin less than or equal to 2.5 times the upper limit of normal;
- Potassium level of 3.0 milliequivalent/L or greater;
- Hemoglobin level of 7.0 g/dL or greater;
- Platelet count of 100,000/mm3 or greater;
- Estimated glomerular filtration rate (eGFR; bedside Schwartz formula) 60 mL/min/1.73m2 or higher.
- For children living with HIV:
- On antiretroviral therapy (ART) at Entry: Must be on, or able to be switched to a dolutegravir-based regimen at or prior to Entry;
- Not on ART at Entry: Planned initiation of dolutegravir before or at study Week 4.
- For participants who have reached menarche or who are engaging in sexual activity (self-reported): negative serum or urine pregnancy test within 7 days of Entry.
- For participants who are engaging in sexual activity that could lead to pregnancy (self-reported): agrees to practice at least one non-hormonal method of contraception or abstain from heterosexual intercourse during...
- Male or female condoms
- Diaphragm or cervical cap (with spermicide, if available)
- Non-hormonal intrauterine device (IUD) or intrauterine system (IUS)
- At Entry, intends to remain in the catchment area of the study site for the duration of study follow-up or willingness to be followed up beyond the catchment area if/when applicable, as determined by the site...
- Presumed or documented extra-pulmonary TB involving the central nervous system and/or bones and/or joints, and/or miliary TB, and/or pericardial TB and/or TB of the gastrointestinal (GI) tract and/or renal TB.
- Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry.
- Any known contraindication to taking any study drug:
- Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs;
- Any prohibited medications within three days prior to Entry or planned use within the following 6 months;
- Unable to take oral medications;
- Known history of prolonged QT syndrome not caused by electrolyte derangements.
- Received more than 10 days of treatment directed against TB disease within 6 months preceding initiation of study drugs.
- M. tuberculosis isolate known or suspected to be resistant to isoniazid, rifampin, pyrazinamide, ethambutol, and/or fluoroquinolones.
- Known exposure to an infectious adult with drug-resistant TB, including resistance to isoniazid, rifampin, pyrazinamide, ethambutol, and/or fluoroquinolones.
- Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate...
- Previously enrolled in this study. Late Exclusions:
- M. tuberculosis cultured or detected through World Health Organization (WHO) approved molecular assays (e.g., Cepheid Xpert MTB/RIF, Xpert XDR, sequencing or Hain MTB-DR plus assays) from sputum, swallowed sputum...
- Any child with a clinical TB diagnosis who is found to have a definitive alternative diagnosis for their presenting signs and symptoms whose TB treatment is discontinued prior to completion.
The study team makes the final eligibility decision.
Where it's taking place
- Chennai, India
- Pune, India
- Bandung, Indonesia
- Maputo, Mozambique
- Durban, South Africa
- Kampala, Uganda
- Lusaka, Zambia
- Ndola, Zambia
- Harare, Zimbabwe
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 9 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chennai, India; Pune, India; Bandung, Indonesia; Maputo, Mozambique; Durban, South Africa; Kampala, Uganda and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.