A Phase 1b, Multi-center Study of IV Gallium Nitrate in Patients with Cystic Fibrosis who are colonized with Nontuberculous Mycobacteria (the ABATE study)

Date Added
September 1st, 2022
PRO Number
Pro00123092
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis, Nontuberculous mycobacteria (NTM)
Summary

This is a prospective, multicenter open-label study in adults with CF who are colonized with NTM. Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium. Subjects will be on study for up to 148 days, with a screening period of up to 7 days and active study period up to 20 days. About 40 people with CF who are 18 years of age or older will take part in this study at about 10 hospitals and clinics around the country.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Standardizing Treatments for Pulmonary Exacerbations: A platform for evaluating treatment decisions to improve outcomes (STOP360)

Date Added
November 22nd, 2022
PRO Number
Pro00124625
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis
Summary

The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF pulmonary exacerbations during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean ppFEV1 (pulmonary function testing) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms. The study will compare treatment of an intravenous aminoglycoside and β-lactams (AG) versus intravenous β-lactams only (non-AG) in people with CF diagnosed with a pulmonary exacerbation who will be treated for Pa.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A MULTI-CENTER STUDY OF NON-INVASIVE COLORECTAL CANCER EVALUATION IN CYSTIC FIBROSIS (NICE-CF)

Date Added
December 1st, 2022
PRO Number
Pro00124304
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis
Summary

This is a cross-sectional, multi-center study comparing stool-based testing (multi-target DNA-based test and quantitative FIT test) to standard of care colonoscopy for CRC screening in PwCF. The study includes an enrollment visit, two stool samples completed at home, a clinical screening colonoscopy, and three participant surveys which will be completed at enrollment and remotely.
The total duration of participant participation will be 3-12 months, depending on the timing of the completion of the stool sample and the participant's colonoscopy. The targeted participant timeline is 3 months from enrollment to the completion of a clinical screening colonoscopy. To allow for varying site-specific clinical colonoscopy scheduling delays and COVID delays in scheduling, the duration of time between stool sampling and screening colonoscopy may extend up to 12 months for inclusion of data in the study. However, greater than 3 months duration between stool-based testing and colonoscopy will be considered a protocol deviation.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF (STRONG-CF)

Date Added
June 19th, 2023
PRO Number
Pro00129339
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis
Summary

This is a prospective, multicenter observational study to investigate clinical markers of nutritional status, physical frailty, and sarcopenia in adults with CF spanning a range of lung impairment and to identify barriers and risk factors to optimize nutrition and physical functioning in this patient population. Repeat measurements of body composition and physical function by various methods will be taken during the study and compared to clinical outcomes, as well as with each other. Smaller sub-set studies will be performed to assess bioimpedance analysis (BIA) and/or ultrasound as measures of body composition. Two cohorts matched by age, sex, race, and CFTR genotype severity will be enrolled: (1) those with FEV1 <60% and (2) those with FEV1 ≥60%.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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