Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis

Официальное название

A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults With Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis

Обзор

A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis

Подробное описание

This is a single-centre, open-label, single arm, clinical trial in two sequential stages, with no stratification. 12 patients will be enrolled in Stage 1, and a further 12 patients will be enrolled in Stage 2 (total of 24 patients in the trial).

Вмешательства

• Препарат RESP30TB
  Nitric Oxide agent
• Препарат HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
  isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)

Первичные конечные точки

• Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Dosing period 14 days + Follow-up period 14 days]

Критерии участия

Критерии включения

• Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial procedures.
• Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
• Newly diagnosed pulmonary TB.
• Rifampicin susceptible pulmonary TB as determined by molecular testing.
• Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 mL or more).
• Spirometry performed during screening with a Forced Expiration Volume in the first second (FEV1) of ≥ 40%.
• Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4.

Критерии исключения

• HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART)
• Baseline Methaemoglobin saturation (SpMet) >3%.
• Female patients who is pregnant or breast-feeding.
• Patients planning to conceive a child within the anticipated period of trial participation and for at least 90 days after the last dose of IMP in the trial.
• Participation in other clinical studies with investigational agents within 8 weeks prior to screening.
• Treatment received for this episode of TB with any drug active against M.tb
• Treatment with immunosuppressive medications such as TNF-alpha inhibitors within 2 weeks prior to screening, or systemic corticosteroids for more than 7 days within 2 weeks prior to screening.
• Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

ЮАР · 1 центр

• TASK Clinical Research Centre — Cape Town

Идентификаторы

NCT: NCT07073638 · RESP30TB-EBA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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