If you are living with NTM lung infection caused by Mycobacterium abscessus Complex (MABc), you may qualify for a research study and receive an investigational drug (or placebo) and study-related care from a study doctor.
If you are living with NTM lung infection caused by Mycobacterium abscessus Complex (MABc), you may qualify for a research study and receive an investigational drug (or placebo) and study-related care from a study doctor.
Recruitment is now underway for a new clinical research study in patients with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Abscessus Complex (MABc). The study is evaluating an investigational drug, taken orally, once daily.
You may qualify for this study if you:
This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you and determine if you may qualify to participate.
If you qualify and agree to take part, you will:
You will have an in-person visit to a research site so they can assess if you meet the criteria to participate in the study by:
If you qualify and agree to take part, you will be asked to attend monthly in-person visits at the research site. During the visits, you will:
During the Treatment Period, you will be asked to take study medication (investigational drug or placebo) every day for up to 3 months. You will not be able to take other medications to treat your NTM lung infection during this time.
Assistance with travel & expenses associated with travel to/from study visits may be provided.
About 30 days after you finish taking the study medication, you will have a phone call with the research site staff to tell them how you are feeling.
Currently there are no FDA-approved treatments for NTM lung infections caused by MABc, further highlighting the importance of the PTK0796-NTM-20203 study to the NTM community. A clinical study is a way to evaluate a drug in people with a certain illness. Some clinical studies (or "clinical trials") investigate drugs that doctors cannot yet prescribe. A goal of a clinical study is to learn if an "investigational drug" is safe and effective for people to take. Effective means it helps in some way to use the investigational drug for a certain disease or illness. Participating in this study may include:
Carefully consider the benefits and risks of a clinical trial. Talk with your healthcare provider, your family, and the site research team. Ask questions and discuss your concerns. The more you know about clinical trials, the better prepared you will be to participate and receive the care you expect.
A clinical study is a research study that tests a medicine or treatments in people. Clinical studies are also sometimes called clinical trials or clinical research. Clinical research helps us answer questions about the medicine/treatment being studied, like does it work and is it safe. They involve collecting information from study tests and procedures to answer certain questions. They may or may not directly benefit the participant, but the study results may help patients in the future. Clinical studies are voluntary, so it is up to the participant to decide if he or she wants to be in a clinical study. More information about studies being conducted and results from completed studies can be found at clinicaltrials.gov.
Studies have criteria that must be met in order to participate. The set of criteria to enter each clinical study is chosen carefully and is specific to the study. For each trial, this set of criteria is needed to prove whether a medicine works and is safe in a specific patient population. These requirements are applied equally to potential participants before they join the study. Trial criteria are based on things like age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Carefully consider the benefits and risks of a clinical trial. Talk with your healthcare provider, your family, and the site research team. Ask questions and discuss your concerns. The more you know about clinical trials, the better prepared you will be to participate and receive the care you expect.
Before a clinical study can start, it must be reviewed by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any possible benefits. Each study follows a carefully controlled plan (protocol) that explains what researchers will do during the study. During the study, researchers report the results to the study’s IRB, to medical journals, and to government agencies. If problems such as severe side effects happen during a study, it may be stopped or paused to protect participants. It is important to remember that you can leave a clinical study at any time for any reason. However, you should always talk to your study site doctor before you stop.
An IRB is a committee of doctors, data experts, community advocates, and others who help ensure that a trial is done in an ethical way and the rights and welfare of participants are protected.
A substance/treatment that is tested in clinical studies to see if it works and is safe for a disease before it can be approved by the US Food & Drug Administration (FDA) or other regulatory agencies outside of the US to be prescribed by a doctor.
Before you decide if you’ll join a clinical trial, learn as much as possible about it. You should feel comfortable asking the study doctor/team all of your questions about the trial, the care you can expect, and if there are costs. This is part of the informed consent process. Carefully consider the benefits and risks of a clinical trial. Talk with your healthcare provider, your family, and the site research team. Ask questions and discuss your concerns. The more you know about clinical trials, the better prepared you will be to participate and receive the care you expect.
Informed consent is the process in which researchers talk with you if you are thinking about enrolling, or have enrolled, in a clinical study. They will have you read an informed consent form (ICF) that describes what will happen to you during the study and possible benefits and risks. It tells you that taking part in the study is voluntary, and that you may leave the study at any time. The goal of the informed consent process is to protect participants who enroll in clinical trials. The informed consent process starts when a possible participant first asks for information about the study and continues until the trial ends. You should not sign an informed consent form until you are comfortable that your questions have been answered.
There are currently no approved drugs to treat NTM lung infections caused by MABc. This study is being done to see how well an investigational drug works (if it is safe and effective) to treat NTM lung infections caused by MABc.
Yes, there have been other clinical trials for the investigational drug for other medical conditions. The investigational drug is currently approved by the FDA to treat two other medical conditions (community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections). This is the first time that the investigational drug is being studied in patients with NTM lung infections caused by MABc.
The investigational drug (or placebo) are tablets that will be taken once a day by mouth.
No. All study related tests and procedures are provided at no cost to you or your health insurance company while in the study. Patients who qualify to participate in the study will receive at no cost: • Investigational drug (or placebo) • Study-related care from the study doctor • Reimbursement for travel expenses associated with study visits You or your health insurance company are responsible for the cost of routine treatment once you exit the study. The study site staff may help you check with your health plan and your doctor about any costs not related to the study.
Participants will be in the study for up to 6 months (including a screening period of up to 8 weeks, a 3-month treatment period, and a 30-day follow-up period).
Approximately 75 participants will be in this research study.
There may be some risks associated with the investigational drug or from study tests and procedures. Before you agree to take participate in the study, your study doctor and staff will provide you with an informed consent form that describes the possible risks and will answer any questions that you may have. Carefully consider the benefits and risks of a clinical trial. Talk with your healthcare provider, your family, and the site research team. Ask questions and discuss your concerns. The more you know about clinical trials, the better prepared you will be to participate and receive the care you expect.
The medical benefits of the investigational drug to treat NTM caused by MABc are not yet known. Your NTM may get better, worse or stay the same.
Yes, participation in a clinical trial is voluntary, and participants are free to leave a clinical study at any time for any reason. It is important to always talk to your study site doctor before you stop participating in a clinical trial.
Please visit: https://clinicaltrials.gov/ct2/show/NCT04922554?term=NCT04922554&draw=2&rank=1
Please visit: www.ntminfo.org
Development of new drugs depends on patients participating in clinical research studies. If you are interested in participating in the PTK0796-NTM-20203 study, please click the button below to locate a participating research site.
Paratek Pharmaceuticals (the sponsor of this clinical study) is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. Paratek’s focus is on drugs for patients, both in and out of the hospital, with infectious diseases and other difficult to treat conditions. Paratek pursues solutions that enable positive outcomes and lead to positive patient stories. Paratek has two office locations in Boston, MA and King of Prussia, PA and more than 200 employees in the United States. For more information about Paratek please visit: www.paratekpharma.com
If you're interested in learning more about the PTK0796-NTM-20203 study, you can find additional details at https://clinicaltrials.gov/ct2/show/NCT04922554.