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NCT03673956

Topical Antibiotics in Chronic Rhinosinusitis

Completed Phase 1, PHASE2 Results posted Last updated 20 April 2022
What this trial tests

Phase 1, PHASE2 trial testing Mupirocin in Chronic Rhinosinusitis (Diagnosis) in 19 participants. Completed in 1 February 2021.

Timeline
26 September 2018
Primary endpoint
1 February 2021
1 February 2021

Quick facts

Lead sponsorMayo Clinic
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment19
Start date26 September 2018
Primary completion1 February 2021
Estimated completion1 February 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

Adults 18 to 80, any sex, with Chronic Rhinosinusitis (Diagnosis). 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.

Subjects Who Developed Antibiotic Resistance Organisms Primary · Post-intervention (within 21 days of intervention completion)

Number of subjects who developed new antibiotic resistance organisms measured by nasal swab of the affected sinonasal cavity and sent for stain, culture, and sensitivity.

GroupValue95% CI
Mupirocin Antibiotic Nasal Saline Rinse0
Tobramycin Topical Antibiotic Nasal Saline Rinse0
Levofloxacin Topical Antibiotic Nasal Saline Rinse1
Vancomycin Topical Antibiotic Nasal Saline Rinse0
Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey Secondary · Baseline, Post-intervention (within 21 days of intervention completion)

Scores are measured from 0-5 in a 22-item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms.

GroupValue95% CI
Mupirocin Antibiotic Nasal Saline Rinse-18± 21.8
Tobramycin Topical Antibiotic Nasal Saline Rinse14
Levofloxacin Topical Antibiotic Nasal Saline Rinse-25.5± 34.6
Vancomycin Topical Antibiotic Nasal Saline Rinse-11
Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores. Secondary · Baseline, Post-intervention (within 21 days of intervention completion)

Scores are measured on a 0-2 scale for nasal polyps, edema, and secretions in both right and left nasal cavities. Total scores range from 0 to 12 with higher scores indicating greater evidence of sinonasal disease on physical exam.

GroupValue95% CI
Mupirocin Antibiotic Nasal Saline Rinse-5.3± 2.8
Tobramycin Topical Antibiotic Nasal Saline Rinse-3
Levofloxacin Topical Antibiotic Nasal Saline Rinse-2.4± 2.4
Vancomycin Topical Antibiotic Nasal Saline Rinse0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mupirocin Antibiotic Nasal Saline Rinse
Serious: 0/12 (0%)
Deaths: 0/12
Tobramycin Topical Antibiotic Nasal Saline Rinse
Serious: 0/1 (0%)
Deaths: 0/1
Levofloxacin Topical Antibiotic Nasal Saline Rinse
Serious: 0/5 (0%)
Deaths: 0/5
Vancomycin Topical Antibiotic Nasal Saline Rinse
Serious: 0/1 (0%)
Deaths: 0/1
Other adverse events (5 terms — click to expand)

ReactionSystemMupirocin Antibiotic Nasal…Tobramycin Topical Antibio…Levofloxacin Topical Antib…Vancomycin Topical Antibio…
HeadacheNervous system disorders
Face PainGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders
Facial PressureGeneral disorders
Nasal DrainageGeneral disorders

Data from ClinicalTrials.gov NCT03673956 adverse events section.

Sponsor's own description

Researchers are trying to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Mupirocin

Trials testing the same drug.

Other recruiting trials for Chronic Rhinosinusitis (Diagnosis)

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03673956.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing