CLINICAL TRIAL

WHAT IS CLINICAL TRIAL?

A clinical trial is defined as any research study that assigns human participants or groups to one or more health-related interventions to assess their effects on health outcomes. These studies, also known as interventional trials, can involve a wide range of interventions, including but not limited to drugs, biological products (such as cells), surgical and radiologic procedures, medical devices, behavioral therapies, changes in care processes, and preventive measures. This definition encompasses trials from Phase I through Phase IV. Source Link: World Health Organization

Category: List of Studies

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Prospective, Duration-Randomized, Partially Blinded, Phase 2 Study of the Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients with MDR-TB
Short Title/ Acronym: DRAMATIC Trial
Status: Enrolling

Description:

DRAMATIC (Duration Randomized Anti-MDR-TB And Tailored Intervention Clinical) Trial is a multicenter, randomized, partially blinded, four-arm, phase 2 trial that will examine an injectable- and pyrazinamide-sparing regimen of bedaquiline, delamanid, levofloxacin, linezolid, and clofazimine for treatment of MDR-TB. Participants will be randomized (1:1:1:1) to the following four investigational arms. All arms receive the same investigational oral regimen of levofloxacin, bedaquiline, linezolid, delamanid, and clofazimine; each arm represents a different the total duration of treatment, specifically 16 weeks (112 doses), 24 weeks (168 doses), 32 weeks (224 doses) or 40 weeks (280 doses).

Eligibility:

Adult: 18 years of age or older Children: 12-17 years of age Are HIV seropositive (with or without baseline antiretroviral therapy) or negative (but not unknown) Have pulmonary MDR-TB with sputum that contains M. tuberculosis that is rifampin-resistant and fluoroquinolone-susceptible by a validated molecular test
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Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients PHOENIx MDR-TB
Short Title/ Acronym: PHOENIx MDR-TB
Status: Enrolling

Description:

A Phase III, open-label, multicenter trial with a cluster-randomized superiority design (eligible contacts in the same household [HH] are a cluster), to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active TB during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.

Eligibility:

An index case is defined as an adult (18 years and older) with pulmonary MDR-TB who has started MDR-TB treatment within the past 90 days Children 0 to < 5 years of age regardless of tuberculin skin test (TST)/interferon gamma release assay (IGRA), or HIV status
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A Phase II, Prospective, Randomized, Multicenter Trial to Evaluate the Efficacy and Safety/Tolerability of Two Linezolid Dosing Strategies in Combination with a Short Course Regimen for the Treatment of Drug-Resistant Tuberculosis
Short Title/ Acronym:
Status: Closed to Accrual

Desciption:

A phase II, prospective, randomized, two-arm, open-label, multicenter clinical trial to evaluate the anti-tuberculosis (TB) activity, safety, and tolerability of an injectable-free short course regimen for treatment of multidrug-/rifampicin-resistant (MDR-/RR-), pre-extensively drug-resistant (pre-XDR-), and extensively drug-resistant (XDR-) TB comparing two dosing strategies of linezolid (LZD) combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ).

Eligibility:

Participants aged 18 years and older, with or without HIV, with newly diagnosed pulmonary MDR/RR-TB, pre-XDR-TB, or XDR-TB (collectively noted as DR-TB in the protocol) Participants living with HIV are required to either be on ART or be willing to start ART within 30 days after entry.
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A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine Compared to a Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age
Short Title/ Acronym:
Status: Closed to Accrual

Desciption:

Phase 3/3b efficacy study to demonstrate the efficacy of the aQIV vaccine compared to an influenza comparator vaccine in the prevention of laboratory-confirmed influenza A and/or B in adults aged 65 years and older.

Eligibility:

Gender: Male and Female Adults aged 65 years and older with no or stable comorbidities.
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A Phase 2b/c, Multi-Arm, 2- Stage, Duration Randomized Trial of the Efficacy and Safety of Two to Four Months Treatment with Regimens Containing Bedaquiline OPC-167832, and Sutezolid, Plus Either Pretomanid or Delamanid, in Adults with Pulmonary Tuberculosis
Short Title/ Acronym: PAN TB
Status: Closed to Accrual

Desciption:

This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).

Eligibility:

Between 18 and 65 (inclusive) years of age Both sexes will be eligible for the trial if they have recently diagnosed, untreated (≤4 days of treatment), microbiologically confirmed, drug susceptible, pulmonary Tuberculosis.
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A Phase 2, Randomized, Adaptive, Dose-ranging, Open-label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Short Title/ Acronym: RAD-TB
Status: Pending Site Activation

Description:

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. The adaptive design allows for regimens to be added during the trial for efficient testing of new drugs and drug combinations, identified as promising via translational modeling, against the standard of care (SOC) within the same trial infrastructure.

Eligibility:

Ages 18 years and above Participants with Xpert MTB/RIF positive drug-susceptible pulmonary TB Living with and without HIV
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IMAGINE-TBM (A5384): Improved Management with Antimicrobial aGents Isoniazid rifampiciN LinEzolid for TBM
Short Title/ Acronym: Imagine TBM
Status: Pending Site Activation

Description:

A Phase II, Randomized, Open-Label Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid and Pyrazinamide versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents with Tuberculous Meningitis

Eligibility:

Ages 15 and above Gender: Male and Female participants Who has a defnite, probable or possible TB meningitis diagnosis with or without HIV co-infection
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An open-label, multi-center Phase I/II trial of the pharmacokinetics, safety, tolerability and acceptability of new formulations of clofazimine and moxifloxacin in children routinely treated for rifampicin-resistant tuberculosis
Short Title/ Acronym: CATALYST
Status: Completed

Description:

This is an open-label, multicentre phase I/II trial of the pharmacokinetics, safety and acceptability of novel formulations of moxifloxacin and clofazimine in children routinely treated for RR-TB.

Eligibility:

HIV-infected and -uninfected children from birth to < 15 years of age Who had either clinically diagnosed or confirmed RR-TB and had started RR-TB treatment in routine care
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ACost Estimation of TB treatment under BPaL based regimen in the Philippines
Short Title/ Acronym: BPaL Costing Study
Status: Completed

Description:

This was a cross-sectional study which estimated the patient and provider costs of BPaL compared to current standard-of-care treatment in the Philippines.

Abstract:

Patients on BPaL under operational research, or 9–11-month standard short oral regimen (SSOR). And 18–21-month standard long oral regimen (SLOR) under programmatic conditions were interviewed using the WHO cross-sectional TB patient cost tool. Provider costs were assessed through a bottom-up and top-down costing analysis.
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A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
Short Title/ Acronym: A5397/HVTN 603
Status: Pending Site Activation

Description:

A5397/HVTN 603 is a double-blinded, placebo-controlled study which will give participants 2 injections of a study vaccine called ID93+GLA-SE or a placebo at different times after they have started taking TB treatment. The researchers will compare responses in people who get the study vaccine to people who get the placebo. This study will enroll both people with and without HIV. It is the first to test ID93 + GLA-SE in people living with HIV (PLWH).

Eligibility:

People aged 18 years or older who have: pulmonary TB that is sensitive to certain TB medications. Do not have drug resistant TB and have not been treated for TB previously. Started standard TB treatment (per local guidelines) within the past 7 days and are living with or without HIV. For PLWH: taking HIV treatment for at least 90 days with an undetectable viral load and a CD4 count at least 250.