CTRI/2025/07/091671尚未招募2 期
A Phase 2 Randomized, Adaptive Dose- Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB).
NIH DAIDS1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2025年11月3日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Difference in mean log10 (Time to positivity (TTP)) slope from longitudinal mycobacteria growth indicator tube (MGIT) liquid culture measurements over the first 6 weeks of treatment [ Time Frame: Weeks 0, 1, 2, 3, 4 and 6 ]
研究概览
简要总结
A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).
A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)].
The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •pulmonary TB among individuals either without history of prior TB treatment or with history of TB treatment more than 5 years prior to study entry identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert Semiquantitative Mtb results of medium or high are required Pulmonary TB with documented INH susceptibility by Line Probe Assay LPA or Xpert MTB XDR or other validated molecular test and with documented RIF susceptibility by LPA or Xpert MTBRIF or Xpert MTBRIF Ultra or other validated molecular test within 7 days prior to study entry Documentation of HIV1 infection status as below Presence or Absence of HIV1 infection as documented by Any licensed rapid HIV test or HIV1 enzyme or chemiluminescence immunoassay ECIA test kit any time prior to study entry AND Confirmed by one of the following A second antibody test from different manufacturers or based on different principles and epitopes combination antigenantibodybased rapid tests may be used or HIV1 antigen or Plasma HIV1 RNA viral load or A licensed Western blot For individuals with HIV CD4 cell count 100 cellsmm3 based on testing performed within 30 days prior to study entry For individuals with HIV Currently being treated with dolutegravir-based antiretroviral therapy ART or plan to initiate dolutegravir-based ART at or before study week 8 Individuals age 18 years The following laboratory values obtained within 7 days prior to study entry at any network-approved nonUS laboratory that operates in accordance with Good Clinical Laboratory Practices GCLP and participates in appropriate external quality assurance programs Serum or plasma alanine aminotransferase ALT3 times the upper limit of normal ULN Serum or plasma total bilirubin 2 times ULN Serum or plasma creatinine 2 times ULN Serum or plasma potassium 3 5 mEqL Serum or plasma magnesium 1 0 mEqL 0 500 mmolL Absolute neutrophil count ANC 1500mm3 Hemoglobin 9 5 gdL for individuals assigned to female sex at birth and 10 g dL for individuals assigned to male sex at birth Platelet count 100000 mm3 Negative for hepatitis B core antibody HBcAb total hepatitis B surface antigen HBsAg Negative for hepatitis C virus HCV antibody or if HCV antibody positive must have a negative HCV PCR For individuals assigned to female sex at birth and who are of reproductive potential negative pregnancy test urine HCG or serum βHCG within 3 days 72 hours prior to entry by any network approved nonUS laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs Individuals assigned to female sex at birth who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications Male or female condoms Diaphragm or cervical cap with spermicide if available Intrauterine device IUD or intrauterine system IUS Hormone based birth control eg oral contraceptives DepoProvera NuvaRing implants For individuals who are assigned male sex at birth who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives They are also strongly advised to inform their nonpregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation For individuals assigned male sex at birth with pregnant partners willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation For individuals assigned male sex at birth willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation Documentation of Karnofsky performance score 60 obtained within 14 days prior to study entry Chest xray obtained within 14 days prior to study entry A verifiable address or residence readily accessible for visiting and willingness to inform the study team of any change of address during study treatment and follow-up period Ability and willingness of individual to provide informed consent.
排除标准
- •More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry Current extrapulmonary TB in the opinion of the investigator QTcF interval 450 ms within 7 days prior to study entry History of or ongoing heart failure Personal or family history of congenital QT prolongation History of known untreated ongoing hypothyroidism History of or ongoing bradyarrhythmia History of torsades de pointes Current Grade 2 or higher peripheral neuropathy Other medical conditions eg diabetes liver or kidney disease blood disorders chronic diarrhea in the opinion of the site investigator in which the current clinical condition of the participant is likely to prejudice the response to or assessment of treatment Pregnant or breastfeeding or planning to become pregnant within the next 12 months Weight 35 kg Unable to take oral medications Taking any of prohibited medications Known allergy sensitivity or any hypersensitivity to components of investigational agents or their formulation Active drug or alcohol use or dependence or mental illness eg major depression that, in the opinion of the site investigator would interfere with adherence to study requirements Taking an investigational drug or vaccine within 30 or more days prior to study entry.
结局指标
主要结局
Difference in mean log10 (Time to positivity (TTP)) slope from longitudinal mycobacteria growth indicator tube (MGIT) liquid culture measurements over the first 6 weeks of treatment [ Time Frame: Weeks 0, 1, 2, 3, 4 and 6 ]
时间窗: 8 weeks
for each experimental treatment arm compared to the SOC arm
时间窗: 8 weeks
Difference in the cumulative proportion of participants having at least one new Grade 3 or higher adverse event (AE) by week 8 of treatment [ Time Frame: 8 weeks ]
时间窗: 8 weeks
次要结局
- Cumulative proportion of participants with stable sputum culture conversion by week 8 as measured by culture-negative status via MGIT liquid culture at two consecutive measurements(Mean log10 TTP slope from longitudinal MGIT liquid culture measurements over the first 8 weeks of treatment)
研究者
Dr Sanjay Gaikwad
BJ Medical College and Sassoon General Hospital
研究点 (1)
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