Research Study for Patients with Nontuberculous Mycobacterial (NTM) Infection
OHSU’s Division of Infectious Diseases Clinic has a study for patients with newly diagnosed nontuberculous mycobacterial (NTM) infection.
NTM disease is an infection caused by a number of different bacterium called nontuberculous mycobacterium. The purpose of the study is to see if differences exist between the immune system of patients with NTM disease that gets worse and those who stay relatively healthy. If you have been diagnosed with NTM infection, either in the lungs or in another area of the body, you may be eligible for this study.
To qualify for this study, you:
- Must be diagnosed with NTM infection in 2012 or 2013
- Must be older than 18 years of age
- Must meet other study criteria
- Must not be infected with HIV
If you qualify, your participation in the study will last about 1 hour to an hour and a half. All subjects who qualify for this study will have their blood drawn for research. You will also fill out a brief survey about your current symptoms and medical history.
Blood samples will be saved for future research. Study participants will not be contacted once they completed the blood draw.
Participation is voluntary and anyone can withdraw at any time. You will receive a $10 gift card for your time and participation.
You can learn more about this study and have your questions answered by calling Sarah Siegel (Study Coordinator) at 503-494-3560 or Kevin Winthrop (Principal Investigator) at 503-494-5496.
This is research and not treatment.
OHSU IRB Number eIRB # 9463
Researchers at the University of Florida are studying potential risk factors associated with gastrointestinal intolerance of currently recommended multidrug treatment for pulmonary M. avium complex (MAC)
This study is recruiting women, age 50 or older with pulmonary MAC disease who have been on anti-mycobacterial medications for at least two weeks.
Those who are eligible and agree to participate in this research study will be asked to complete several self-administered questionnaires and to visit the University of Florida in Gainesville, Florida on five separate occasions over a period of approximately nine weeks.
During these visit, study participants will be interviewed regarding their medical history and diet, have their blood drawn, undergo tests of their body composition and tests of heart function. This will require approximately 6 hours on five separate days. Study participants will be compensated.
If interested, please contact Jennifer Hosford, Research Assistant, by phoning 352-273-9584.
Will you participate? ARIKACE Clinical Trail Now Enrolling, Designated Orphan Drug for NTM Treatment
Recruitment is now underway at 17 sites around the country for a multi-center clinical trial of ARIKACE – inhaled liposomal Amikacin – to treat pulmonary NTM disease. As of March 2013, ARIKACE has been designated by the US Food & Drug Administration (FDA) as an "orphan drug" for the treatment of NTM lung disease.
“Arikace is potentially the most significant development in recent years for the fight against pulmonary NTM, and its designation of Orphan Drug status is an exciting development for all NTM patients, as this designation is based on real data and confers tax incentives to continue work to bring this potentially important drug to market,” said Philip Leitman, President of NTM Info & Research.
“Arikace has several advantages over Amikacin, including a longer half life, and possibly a greater ability to penetrate both biofilms and macrophages, which may make the drug more effective. Although these expectations need to be verified in the clinical trial, I am truly excited by what I have been told,” he added.
The participating sites recruiting patients for the Phase 2 clinical trial, called TARGET-NTM (Treatment with ARIKACE to Realize Greater Efficacy Trial), are listed below with contact information.
ALABAMA: University of Alabama at Birmingham; contact Valerie Eubanks Tarn at firstname.lastname@example.org or 205-558-2940.
CALIFORNIA: Stanford University Medical Center; contact Susan Jacobs at email@example.com or 650-725-8082.
COLORADO: National Jewish Health; contact Kim McPeak at firstname.lastname@example.org or 303-398-1708.
D.C.: Georgetown University; contact D. Michele Cooney at email@example.com or 202-444-4982.
FLORIDA (Gainesville): University of Florida, Pulmonary Division; contact Christina Eagan at Christina.Eagan@medicine.ufl.edu or 352-273-8990.
FLORIDA (Miami): University of Miami; contact Eliana Mendes at firstname.lastname@example.org or 305-243-2568.
FLORIDA (Tampa): Tampa General Hospital; contact Suzanne Roberson at email@example.com or 813-844-7179.
KANSAS (Kansas City): University of Kansas Medical Center; contact Adam Schooley at firstname.lastname@example.org or 913-588-4022.
MARYLAND: NIH/NIAID; contact Charles Fiorentino at email@example.com or 301-443-5447.
NEW YORK: NYU Medical Center; contact Stephanie Lau at firstname.lastname@example.org or 212-263-7951.
NORTH CAROLINA: UNC Chapel Hill; contact Sharikia Burt at Sharikia_Burt@med.unc.edu or 919-966-2531.
OHIO (Cleveland): Case Medical Center's Rainbow Babies & Children's Hospital; contact David Weaver at email@example.com or 216-844-1841, or Colette Bucur at firstname.lastname@example.org or 216-844-1902.
OREGON: Oregon Health & Science University; contact Jennifer Ku at email@example.com or 503-494-1384.
SOUTH CAROLINA: Medical University of South Carolina; contact Ashley Jones at firstname.lastname@example.org or 843-792-4349.
WISCONSIN: Medical College of Wisconsin & Froedtert Hospital; contact Rachel Harris at email@example.com or 414-955-7030.
If information on other participating centers becomes publicly available, that information will be added to this page on our website.
Below is a list of Key Inclusion and Exclusion Criteria for participation in the study.
Key Inclusion Criteria:
- Diagnosis of pulmonary NTM disease in accordance with ATS/IDSA criteria with evidence of nodular bronchiectasis and/or cavitary disease by CT scan.
- History of infection with either Mycobacterium avium complex (MAC) or Mycobacterium abscessus (or both), with at least 2 documented positive sputum cultures in the prior 2 years – at least one positive culture within 6 months prior to screening for clinical trial participation.
- Positive sputum culture obtained at screening visit (either MAC or abscessus, or both).
- Receiving ATS/IDSA guidelines-based treatment regimen for at least 6 months prior to screening with persistently positive sputum cultures.
- Ability to produce at least 3mL of sputum or willingness to undergo an induction that produces at least 3 mL of sputum for clinical evaluation.
- If a female of childbearing potential, patient must agree to practice an acceptable method of birth control.
- Male or female between 18 and 85 years of age.
Key Exclusion Criteria:
- Forced expiratory volume in one second less than 30% of predicted at screening.
- Active pulmonary malignancy, or any malignancy requiring radiation or chemotherapy within one year prior to screening, or anticipated during the study period.
- Pulmonary tuberculosis requiring treatment or treated within 2 years.
- History of lung transplantation.
- Clinically significant cardiac disease.
- Hemoptysis of 60 mL or more in a 24-hour period within 4 weeks prior to screening.
- Active allergic bronchopulmonary mycosis or any other condition requiring systemic steroids at a dose equivalent to at least 10 mg/day of prednisone within 3 months prior to screening, or anticipated during the study period.
- Hypersensitivity to aminoglycosides.
- Any change in chronic multi-drug regimen for NTM within 28 days prior to Study Day 1.
- Evidence of biliary cirrhosis with portal hypertension.
- History of daily, continuous oxygen supplementation.
- Smoking tobacco or any substance within 6 months prior to screening, or anticipated inability to refrain from smoking throughout the study
There is a new, multi-centered clinical research study of a new product for use in patients with Bronchiectasis. This study is funded and sponsored by an Australian pharmaceutical company called Pharmaxis Ltd. This letter is to provide you with some general information about this trial, and to invite you to discuss this study with us, should you be interested in participating.
The name of the research trial is “A phase III multicenter, randomized, parallel group, controlled, double blind study to investigate the safety and efficacy of inhaled mannitol over 12 months in treatment of bronchiectasis.”
An inhalable powder of mannitol is a new investigative medication which, it is hoped, will help to change the moisture of lung mucus, making it thinner so that it is easier to clear and so that physiotherapy will be more effective. Previous studies have shown that patients with bronchiectasis who have been treated with mannitol have shown an improvement in quality of life, less need for antibiotics and were able to clear more mucus from their lungs. The information from this study may help us to treat people with bronchiectasis in the future.
This study is being conducted in hospitals in the USA, UK, Germany, Australia, New Zealand, Belgium, Netherlands, Chile and Argentina and a total of 474 people with bronchiectasis will take part.
We are asking for people with Bronchiectasis to consider taking part in this research study. In particular we are seeking people who have chronic mucus production that is associated with recurrent chest infections. Not all people who would like to take part in this study are suitable though, for example; smokers, those who have very poor or very good lung function, and pregnant or breastfeeding women cannot be included. In addition, people who are currently using hypertonic saline, must be prepared to stop using this for 14 days before the study and for the duration of the study.
Study participants will receive either inhaled mannitol or a placebo-control (a ‘dummy’ study medication, although it looks and tastes like mannitol, it will not have an effect on respiratory symptoms).
The study consists of 9 visits over a year. Each visit will last for about 1-2 hours. The first two visits will be used to determine eligibility to enter the study and record details such as: past medical history, current medications, weight, height and age.
The procedures which will be conducted at most of the study visits will include: a brief physical examination, lung function testing and quality of life questionnaires. A small blood sample and sputum sample will also be collected at each visit in order to monitor safety. Apart from the study medication, a self administered physiotherapy device called an Acapella will be provided, which will help to mobilize the mucus prior to study visits.
There are risks, discomforts and inconveniences associated with any research study or medicine. Inhaled mannitol can cause side effects although not everybody gets them. The most common side effects reported for inhaled mannitol in studies are: cough, headache, sore throat, nausea (feeling sick), discomfort in the chest and shortness of breath. Wheezing and coughing up blood may also occur, less frequently, and may rarely be severe in some patients.
Without treatment, wheeze induced by inhaled mannitol will resolve on its own within 60 minutes in most cases, or is quickly reversible with medication (salbutamol/albuterol). Dry or sore throat may be reduced by taking a drink after each treatment.
Participants will not be responsible for any costs for the required study visits, examinations, procedures, and drug supplies. Participants will be reimbursed for reasonable transport costs associated with the study.
Below is a list of all 19 study locations that are currently recruiting patients for this study. If you are interested in participating, please directly contact the study staff at the below locations for information:
|National Jewish Medical and Research Center||Denver, CO||Dr. Charles Daley & Nina Thompson||303-398-1911|
|University of Connecticut Health Center, Pulmonary Div.||Farmington, CT||Dr. Mark Metersky & Ruth Howard||860-679-4903|
|-Institution name available upon request-||Washington, DC||Sara Leone||610-363-5120, x102|
|Univ. of Miami, Div. of Pulmonary and Critical Care Medicine||Miami, FL||Dr. Matthias Salathe & Carolina Aguiar||305-243-5545|
|Florida Pulmonary Research Institute, LLC||Winter Park, FL||Dr. Faisal Fakih & Allison Only||407-215-1899|
|Chest Medicine Clinical Research||Skokie, IL||Dr. Vadim Leyenson & Laurelle Gasich||847-679-8470|
|-Institution name available upon request-||Chicago, IL||Sara Leone||610-363-5120, x102|
|-Institution name available upon request-||Rochester, MN||Sara Leone||610-363-5120, x102|
|CardioPulmonary Research Center||Chesterfield, MO||Dr. Neil Ettinger & Sue Merli||314-576-4501|
|Univ. of North Carolina - Chapel Hill||Chapel Hill, NC||Dr. Peadar Noone & Sharikia Burt||919-966-2531|
|Pulmonary and Allergy Associates||Summit, NJ||Dr. Robert Sussman & Marissa Rienton-Lim||908-934-0440, x1902|
|Winthrop University Hospital||Mineola, NY||Dr. Jonathan Ilowite & Betsy Pinnick||516-663-9582|
|Research Associates of New York||New York, NY||Dr. Louis DePalo & Nicole St. Vrestil||212-996-1105|
|The Oregon Clinic, PC||Portland, OR||Dr. Melvin Morganroth & Kim La Morticella||503-963-3183|
|Temple Univ. Hospital, Temple Lung Center||Philadelphia, PA||Dr. Gerard Criner & Sylvia Johnson||215-707-4679|
|-Institution name available upon request-||Philadelphia, PA||Sara Leone||610-363-5120, x102|
|South Carolina Pharmaceutical Research||Spartanburg, SC||Dr. Gregory Feldman & Emily Collins||864-515-0092|
|Alamo Clinical Research||San Antonio, TX||Dr. Peter Fornos & Sandra Gonzales||210-223-3010|
|Pulmonary Associates of Richmond - Clinical Research Division||Richmond, VA||Dr. Ritsu Kuno & Charmaine Taylor||804-323-7002|
Please note that all research visits must take place at Oregon Health & Science University in Portland, Oregon. Blood samples cannot be shipped from outside clinics or labs.
Title: Human T Cell Responses to Mycobacterium avium: Antigen Discovery Project
Principal Investigator: Kevin Winthrop, MD, MPH
Research Institution: Oregon Health & Science University, Portland, OR
Sponsors: ViTi, Inc.
We are researching blood cells to learn more about how people’s immune systems react to Mycobacterium avium complex (MAC). The results of this research may be used to improve tests that diagnose Mycobacterium avium infections (MAC or MAI).
- 18-75 years of age
- Active pulmonary MAC disease
- Weight greater than 110 lbs.
- Immunosuppressed individuals including those with HIV infection or those on potent immunosuppressive drugs, including chronic steroids
- Current use of Coumadin (blood thinner)
- Donation of blood within the last 8 weeks
- Leukapheresis within the past 3 weeks
- Pregnancy or recent childbirth
Participation involves a 30 minute screening visit at OHSU. During this visit, questions will be asked about your Mycobacterium avium infection and 4 tablespoons of blood will be drawn. If the screening test results show you can continue in the study, you will have another visit for a procedure called leukapheresis. In leukapheresis, some of your white blood cells are collected by drawing blood continuously from one arm, putting the blood through a special machine, and returning it to your other arm. This will take approximately 3-4 hours. If you complete both visits, you will receive $300 and may be eligible for up to $50 for travel.
If you are interested in participating, or have questions about the study, please contact Cara Varley (503-494-1384, firstname.lastname@example.org).
Researchers at University of Washington and Oregon Health & Science University (OHSU) are investigating a diagnostic blood test that could make it easier to diagnose MAC/MAI infections faster in the future. This is only for M. avium and M. intracellulare patients.
Volunteers will be asked to provide a small blood sample at OHSU. The study takes 30-60 minutes and volunteers will be compensated $20 for time and travel costs.
The study investigator will also request permission to obtain records from the participant's treating physician to confirm MAC lung disease diagnosis.
**Participants must be from Washington or Oregon.**
For more information, please contact Cara Varley at (503) 494-1966 or email@example.com
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