18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Absolute Change in Forced Expiratory Volume at One Second (FEV1) % Predicted Between Study Arms With Acute Pulmonary Exacerbation (APE) TreatmentPrimary· up to 14 days, from beginning to end of APE treatment
absolute change in forced expiratory volume at one second (FEV1) % predicted, or percent predicted FEV1, between study arms with acute pulmonary exacerbation (APE) treatment
Group
Value
95% CI
Standard Colistin Arm
6.5
± 9.5
Modified Colistin Arm
4.4
± 3.0
Standard Tobramycin Arm
4.5
± 6.3
Rate of Occurrence of the Development of Acute Kidney Injury (AKI) During APE TreatmentPrimary· up to 14 days, from beginning to end of APE treatment
Group
Value
95% CI
Standard Colistin Arm
1
Modified Colistin Arm
0
Standard Tobramycin Arm
5
Longitudinal Differences in Exacerbation Rates Between Tobramycin and Colistin Use as Seen in Readmission RateSecondary· from the beginning of APE treatment to 12 months after APE treatment
time to next admission for exacerbation measured in days when comparing of different antibiotic therapies
Group
Value
95% CI
Standard Colistin Arm
154
± 115
Modified Colistin Arm
283
± 309
Standard Tobramycin Arm
241
± 184
Differences in Occurrences of Neurotoxicity and Ototoxicity Related Side Effects Between Study Arms as Reported by Treating Physician(s)Secondary· up to 14 days, from beginning to end of APE treatment
absolute occurrences of adverse event rates are being compared between treatment groups using logistic regression, adjusting for age, co-administration of medications such as vancomycin and trimethoprim-sulfamethoxazole, baseline FEV1, admits in the previous year, and diagnosis of CF related diabetes (CFRD) as covariates.
Group
Value
95% CI
Standard Colistin Arm
2
Modified Colistin Arm
1
Standard Tobramycin Arm
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 14 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to find the safest and most effective way to administer IV antibiotics to treat acute pulmonary exacerbations (APEs) in patients with cystic fibrosis (CF) that are caused by pathogens, like Pseudomonas aeruginosa. This study will test the safety and effectiveness of two commonly prescribed IV antibiotics: tobramycin and colistin. Though regularly used, not much is known about how these drugs compare with each other in terms of their toxicities, both during short term treatment of an APE and after many treatment courses with these drugs over many years. There are currently no guidelines on the safest and most effective antibiotics to use when treating APEs. We will study kidney function, sputum cultures, and treatment outcomes in patients receiving routine administration of one of these two IV antibiotics. We will also test these outcomes in patients receiving a less frequent dosing schedule for IV colistin. The hope is that this new schedule for IV colistin, which is twice a day and adjusted based on blood and urine tests, will reduce harmful side effects, such as kidney damage, while still being a powerful treatment against CF microbial pathogens.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07326540 — Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients W
· Phase 3
· not yet recruiting
NCT05586815 — Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Carbapenem-Resistant A. Baumannii Infection
· Phase 4
· unknown
NCT05613361 — The Effect of Curcumin Against Colistin-induced Nephrotoxicity
· Phase 3
· unknown
NCT05542446 — Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation
· Phase 4
· terminated
NCT05258851 — Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections
· Phase 3
· terminated
Other recruiting trials for Cystic Fibrosis
Currently open trials in the same condition.
NCT07437105 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants
· Phase 1
· recruiting
NCT07283770 — Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants
· Phase 1
· recruiting
NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine
· recruiting
NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation.
· Phase 3
· recruiting
NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI
· Phase 1, PHASE2
· active not recruiting
Other National Jewish Health trials
Trials by the same sponsor.
NCT06435520 — Enhancing Hypnotic Medication Discontinuation in Primary Care
· Phase 4
· recruiting
NCT06262282 — Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria
· enrolling by invitation
NCT06155747 — Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
· recruiting
NCT04724278 — Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study
· unknown
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Jewish Health
Last refreshed: 21 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02918409.