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IV Gallium for Cystic Fibrosis and NTM Infections (ABATE Trial)
ABATE Trial Summary
This trial will test the safety of two 5-day cycles of gallium given intravenously to adults with CF who also have an infection with NTM.
ABATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowABATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 119 Patients • NCT02354859ABATE Trial Design
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- I have been diagnosed with osteoporosis.I am currently being treated for NTM disease or will start treatment soon.My health has been stable for the last week.My doctor believes my symptoms are due to NTM disease, despite treatment for other infections.Your blood test results show low levels of hemoglobin, platelets, or neutrophil count, high levels of certain liver enzymes, high serum creatinine, or low ionized calcium.You have repeatedly tested positive for certain types of bacteria in the sputum or lung fluid samples. This means that the same bacteria species has been found in your samples over time, or that you have had multiple positive test results within certain timeframes.You can cough up phlegm.I haven't started any new long-term medications in the last 28 days.I am 18 years old or older.I am willing to stop taking azithromycin for the study period.Your nasal potential difference (NPD) test shows a significant change in response to certain solutions.I am not pregnant, breastfeeding, and I agree to use effective birth control if I can have children.You have had two positive sputum or BAL cultures for NTM bacteria, taken at least 28 days apart.Two positive culture results show the same type of bacteria or microorganism.The sweat chloride level is higher than 60 milliequivalent (mEq)/liter in the sweat test.I have two known mutations in my CFTR gene.You have positive test results for certain types of bacteria called M. avium complex or M. abscessus complex.You have a known allergy to gallium.I have had an organ or bone marrow transplant.I am 18 years old or older.I have been diagnosed with cystic fibrosis based on my symptoms.I have not taken azithromycin in the last 14 days.I have not taken bisphosphonates in the week before starting the trial.I haven't used any experimental drugs or joined any clinical trials in the last 28 days.You have not had any negative test results for NTM since the first of the two positive test results.My NTM infection has either never been treated or was successfully treated over 2 years ago.You are able to breathe out a certain amount of air, as tested during screening.
- Group 1: Infusion of IV Gallium
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the upper-limit for participants in this medical experiment?
"This study necessitates the recruitment of 40 qualified applicants. Prospective participants can be recruited from Johns Hopkins University in Baltimore, Maryland and Nationwide Children's Hospital in Columbus, Ohio."
Is this medical experiment currently accepting participants?
"Clinicaltrials.gov currently indicates that this medical trial is actively seeking participants, who would have initially been informed of the study on June 17th 2021 with a most recent update being posted on October 31st 2022."
Has the Federal Drug Administration approved Gallium nitrate for therapeutic use?
"In light of its Phase 1 status, which suggests a limited amount of safety and efficacy data available, the team at Power judged gallium nitrate's safety to be rated as 1."
Is the research project being conducted in multiple Canadian health care centers?
"Currently, 10 different clinical trial sites are hosting this medical research. Participants can select the location closest to them; Baltimore, Columbus and Charleston among other cities offer access to the study. This helps reduce transportation requirements for those taking part in it."
Are there any related research projects that have employed Gallium nitrate?
"The initial research for gallium nitrate began at University of Texas Southwestern in 2021. Subsequently, two completed trials and one active trial have been undertaken; multiple locations are running the ongoing clinical study, most notably Baltimore, Maryland."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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