Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis
The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200/100SPaL-4/13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis.
Participants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either :
- a sorfequiline loading-dose regimen (200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks) plus pretomanid 200 mg and linezolid 600 mg daily, or
- sorfequiline 100 mg daily for 17 weeks plus pretomanid 200 mg and linezolid 600 mg daily. Study treatment is administered orally once daily with food.
The primary objective is to assess safety through 17 weeks of treatment, including treatment-emergent adverse events, ECG findings, vital signs, laboratory assessments, visual acuity, and peripheral neuropathy. Secondary objectives include assessments of efficacy (time to stable sputum culture conversion; favorable outcome and treatment failure/relapse at 26 and 52 weeks after end of treatment) and pharmacokinetics of trial drugs, with exploratory analyses including predictors of culture conversion, exposure-response relationships, and quality of life.
연구 개요
상세 설명
This is a phase 2, randomised, multi-center, partially blinded, clinical trial conducted in 2 treatment arms.
The trial will be performed at multiple centers in South Africa and Tanzania in at approximately 100 participants with DS-TB who meet all the inclusion criteria and none of the exclusion criteria, aged 18 to 65, inclusive. Participants will be randomised to one of the 2 sorfequiline, pretomanid and linezolid containing regimens and will be randomised in 1:1 ratio based on country and severity of disease (AFB 3+ and/or bilateral cavitation). T
The trial will consist of the following periods:
- Screening period: Screening visit, up to 11 days prior to randomisation (Day 1)
Treatment Period: approximately 100 participants will be randomised equally to the 2 treatment arms below:
- Sorfequiline 200 mg + pretomanid 200 mg + linezolid 600 mg for 4 weeks followed by sorfequiline 100 mg for 13 weeks
- Sorfequiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 17 week
- Follow-up Period: 52 weeks after end of treatment
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Morounfolu Olugbosi, MD
- 전화번호: +27 79 045 4917
- 이메일: morounfolu.olugbosi@tballiance.org
연구 연락처 백업
- 이름: Leandra Lombard
- 전화번호: +27 83 30 76784
- 이메일: leandra.lombard@tballiance.org
연구 장소
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East London, 남아프리카, 5201
- 아직 모집하지 않음
- Synergy Biomed Research Institute
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수석 연구원:
- Mookho Malahleha, MD
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연락하다:
- Mookho Mallahleha, MD
- 전화번호: +27 34 722 2306
- 이메일: drmookho@sbri.org.za
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Durban
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Wentworth, Durban, 남아프리카, 4052
- 모병
- Durban International Clinical Research Site
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연락하다:
- Umesh Lalloo, MD
- 전화번호: + 27 31 261 1093/5
- 이메일: lalloo@ecarefoundation.com
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수석 연구원:
- Umesh Lalloo, MD
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Eastern Cape
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Port Elizabeth, Eastern Cape, 남아프리카, 6200
- 모병
- Isango Lethemba TB Research Unit
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수석 연구원:
- Simone Faesen, MD
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연락하다:
- Simone Faesen, MD
- 전화번호: +27 41 492 3195
- 이메일: SimFaesen@witshealth.co.za
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Gauteng
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Soshanguve, Gauteng, 남아프리카, 0152
- 모병
- Setshaba Research Centre
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연락하다:
- Zinhie Zwane, MD
- 전화번호: +27 12 799 2422
- 이메일: Zzwane@setshabe.org.za
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수석 연구원:
- Zinhle Zwane, MD
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Mowbray
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Cape Town, Mowbray, 남아프리카, 7700
- 모병
- University of Capetown Lung Institute
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연락하다:
- Sherman PadayaChee, MD
- 전화번호: +27 21 404 7747
- 이메일: Sherman.Padayachee@uct.ac.za
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수석 연구원:
- Sherman Padayachee, MD
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North West
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Rustenburg, North West, 남아프리카, 2999
- 모병
- The Aurum Institute, Rustenburg
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연락하다:
- William Brumskine, MD
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수석 연구원:
- William Brumskine, MD
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연락하다:
- William Brumskine, MD
- 전화번호: +27 87 135 1575
- 이메일: wbrumskine@auruminstitute.org
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North West Provinvce
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Brits, North West Provinvce, 남아프리카, 0250
- 모병
- Madiberg Centre for Research
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연락하다:
- Lindsey Faul, MD
- 전화번호: +27 12 252 1140
- 이메일: lfaul@madibengresearch.co.za
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수석 연구원:
- Lindsey Faul, MD
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Northwest Province
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Klerksdorp, Northwest Province, 남아프리카, 2571
- 아직 모집하지 않음
- Perinatal HIV Research Unit, Tshepong Hospital
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연락하다:
- Ebrahim Variava, MD
- 전화번호: +27 18 406 3111
- 이메일: variave@phru.co.za
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연락하다:
- Tumelo Moloantoa, MD
- 전화번호: +27 18 011 3800
- 이메일: moloantoat@phru.co.za
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Dar es Salaam, 탄자니아
- 아직 모집하지 않음
- INUKA Africa
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연락하다:
- Frederik Haraka, MD
- 전화번호: +255 22 270 0021/4
- 이메일: fharaka@inuka-africa.org
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수석 연구원:
- Frederik Haraka, MD
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Mbeya, 탄자니아
- 아직 모집하지 않음
- NIMR-Mbeya
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연락하다:
- Christina Manyama, MD
- 전화번호: +255 25 250 3364
- 이메일: christina.manyama@nimr.or.tz
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수석 연구원:
- Christina Manyama, MD
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Moshi, 탄자니아
- 아직 모집하지 않음
- Kilimanjaro Clinical Research Institute(KCRI)
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연락하다:
- Blandina Mmbaga, MD
- 전화번호: +255 27 275 4201
- 이메일: b.nmbaga@kcri.ac.tz
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수석 연구원:
- Blandina Mmbaga, MD
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Mwanza, 탄자니아
- 아직 모집하지 않음
- NIMRI-Mwanza
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연락하다:
- Kidola Jeremiah, MD
- 전화번호: +255 28 250 3012
- 이메일: kiddola.jeremiah@nimri.or..tz
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수석 연구원:
- Kidola Jeremiah, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB
- Of non-childbearing potential OR using effective birth control methods
- Body weight ≥ 35 k
Exclusion Criteria:
- Karnofsky score < 60 at screening
- Any evidence of extrapulmonary TB
- Cardiovascular or QT prolongation risk factors Pregnant or breast-feeding
Laboratory abnormalities as defined in the protocol. • For participants living with HIV only:
- CD4+ count<200 cells/μL.
- WHO Clinical Stage 4 HIV disease
- Participant does not agree to use DTG/TFV/3TC during study treatment if ARV therapy is indicated
- If initiation of ARV therapy is indicated, participants who are known to be intolerant, non-responsive to DTG/TFV/3TC or have DTG/TFV/3TC as a contraindication.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Sorfequline 200/100-Pretomanid 200mg-Linezolid 600mg (Loading Dose)
Regimen (17 weeks total): Weeks 1-4: Sorfequiline 200 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Weeks 5-17: Sorfequiline 100 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily |
Two sorfequiline 100mg tablets taken once daily for 4 weeks then one sorfequiline taken once daily for 13 weeks OR one sorfequiline 100mg tablet taken once daily for 17 weeks (with one 100mg sorfequiline placebo tablet for the first 4 weeks)
다른 이름들:
one 200mg tablet taken once daily for 17 weeks
다른 이름들:
one 600mg tablet taken once daily for 17 weeks
다른 이름들:
|
|
실험적: Sorfequiline 100-Pretomanid 200mg-Linezolid 600mg (No Loading Dose)
Regimen (17 weeks total): Weeks 1-17: Sorfequiline 100 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Includes sorfequiline placebo tablets during first 4weeks to maintain blinding vs the loading regimen. |
Two sorfequiline 100mg tablets taken once daily for 4 weeks then one sorfequiline taken once daily for 13 weeks OR one sorfequiline 100mg tablet taken once daily for 17 weeks (with one 100mg sorfequiline placebo tablet for the first 4 weeks)
다른 이름들:
one 200mg tablet taken once daily for 17 weeks
다른 이름들:
one 600mg tablet taken once daily for 17 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence and characterization of treatment-emergent adverse events (TEAEs)
기간: Through 17 weeks of treatment
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Includes severity, relationship to study drugs, seriousness, TEAEs leading to discontinuation, and TEAEs leading to death; plus safety monitoring endpoints (ECG, vital signs, clinical labs, visual acuity changes, peripheral neuropathy changes.
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Through 17 weeks of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to stable sputum culture conversion (SSCC) to negative
기간: Through 17 weeks of treatment
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SSCC defined as two negative cultures at least 7 days apart without an intervening MTB-positive result (protocol definition used for time-to-event analyses).
Time Frame: Through 17 weeks of treatment
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Through 17 weeks of treatment
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Proportion with favorable outcome
기간: 26 weeks after EOT; 52 weeks after EOT
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Favorable outcome assessed post-treatment; protocol includes evaluation at 26 weeks and 52 weeks after end of treatment
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26 weeks after EOT; 52 weeks after EOT
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공동 작업자 및 조사자
수사관
- 연구 책임자: Morounfolu Olugbosi, TB Alliance
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NC-010
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The results of this trial may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to TB Alliance before submission. This allows TB Alliance to protect proprietary information and to provide comments; such consent will not be withheld unreasonably . Finalized results are published following completion of the trial. At that time, requests for the IPD can be made to C-Path at https://c-path.org/tools-platforms/tb-pacts/
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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