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AI-Designed TB treatment aims for 99.5% cure rate

NCT ID NCT07467252

Disease control Sponsor: Ministry of Health, Saudi Arabia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase II trial tests whether an AI-optimized combination of pyrazinamide and hydroxychloroquine works better than the standard four-drug RIPE regimen for newly diagnosed drug-sensitive pulmonary tuberculosis. Two hundred adults will receive either the new AI-personalized treatment or standard care for 6 months, with follow-up for another 6 months. The study aims to see if the new combo clears the bacteria faster and causes fewer liver side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pyrazinamide and hydroxychloroquine
What this could lead to
If successful, this could lead to a more effective and safer treatment for tuberculosis, potentially curing more patients with fewer side effects.
What could go wrong
This is a Phase II trial with only 200 participants, so results may not apply to everyone. The AI-optimized dosing is new and unproven in humans, and hydroxychloroquine has known risks like heart rhythm problems.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed diagnosis of drug-sensitive pulmonary tuberculosis (bacteriologically confirmed by positive sputum smear microscopy or GeneXpert MTB/RIF) * Age 18 to 65 years * Naive to anti-tuberculosis treatment (no previous TB treatment or less than 1 month of TB treatment in the past) * Willing to provide written informed consent * Able to comply with study visits and procedures * HIV-negative or HIV-positive with CD4 count ≥200 cells/mm³ on stable antiretroviral therapy Exclusion Criteria: * Drug-resistant tuberculosis (confirmed resistance to Rifampicin or Isoniazid) * Severe hepatic impairment (Child-Pugh Class C) or ALT/AST \>3 times upper limit of normal * Severe renal impairment (eGFR \<30 mL/min/1.73m²) * Known hypersensitivity to Pyrazinamide, Hydroxychloroquine, or any RIPE drugs * Pregnancy or breastfeeding * Retinal disease or known contraindications to Hydroxychloroquine * Concomitant use of medications with significant interactions with study drugs * Extrapulmonary tuberculosis as the primary site * Currently enrolled in another clinical trial

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Riyadh First Health Cluster, Ministry of Health

    Riyadh, Riyadh Region, 11176, Saudi Arabia

More trials for these conditions

Other studies related to the condition(s) this trial covers.