Platform Assessing Regimens And Durations In a Global Multisite Consortium for TB [PARADIGM4TB (UNITE4TB – 01)]

Phase 2

• Conditions: Tuberculosis

• Registration Number: PACTR202403493915530
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-09
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1.Age 18 years or above at screening (or above age of legal consent at screening, if this is higher than 18 years in the jurisdiction in which the study is taking place)
2.Clinical evidence of active TB disease, meeting either or both of the following criteria:

•Symptoms consistent with pulmonary TB at screening AND/OR
•Imaging findings consistent with active pulmonary TB on chest X-ray performed at screening or within 7 days prior to screening
3.At least one sputum specimen produced at screening tested on Xpert MTB/RIF Ultra that has:
•a semi-quantitative result of ‘medium' or 'high' AND
•does not show rifampicin resistance
4.Body weight within the range of 30 to 100kg and body mass index within the range of 15 to 40kg/m2
5.Willing to comply with study visits, all study procedures and treatment observation
6.Resident at a fixed address that is readily accessible for visiting, within feasible travelling distance to the site and likely to remain resident there for the duration of trial follow-up
7.Has provided written informed consent

Exclusion Criteria

1.Taken more than 1 daily dose of medication with anti-tuberculous activity during the 14 days prior to randomisation (isoniazid, rifampicin, pyrazinamide, ethambutol; linezolid, moxifloxacin, levofloxacin or amikacin)*
2.Known isoniazid resistance (at sites where national isoniazid monoresistance is greater than 10% rapid testing at screening is mandated; at other sites rapid testing at screening is optional)
3.Known or suspected extra-thoracic TB, miliary TB or disseminated TB (in the judgement of the investigator; note uncomplicated pleural effusion occupying <50% of hemithorax or concomitant intra- or extra-thoracic lymphadenopathy are not exclusions)
4.Severe clinical pulmonary TB e.g. respiratory failure or complications likely to require hospital admission in the opinion of the investigator
5.Poor general condition (Karnofsky score =50) OR where any delay in treatment cannot be tolerated in the opinion of the investigator

6.Active malignancy requiring systemic therapy, radiotherapy or palliative therapy
7.History of myocardial infarction, coronary heart disease or congestive cardiac failure; long QT syndrome or clinically significant arrhythmias; pulmonary hypertension; any known congenital cardiac problems; family history of long QT syndrome or sudden death from unknown or cardiac related cause; uncontrolled arterial hypertension (not excluded if this is corrected prior to randomisation)
8.Vitiligo
9.History of seizure(s)
10.Current tendinitis (any cause) or history of tendinopathy associated with fluoroquinolone use
11.History of vascular aneurysm
12.Symptomatic peripheral neuropathy causing greater than minimal interference with usual social and functional activities
13.Current alcohol or illicit drug use sufficient to compromise the safety of the participant or research staff or compromise adherence to study procedures, in the opinion of the investigator
14.Any current or recent use of amphetamines or methamphetamines, either reported or e

Study & Design

• Study Type: Interventional
• Study Design: Not specified