Trial reportAntimicrobial agents and chemotherapy2006
Absence of cochleotoxicity measured by standard and high-frequency pure tone audiometry in a trial of once- versus three-times-daily tobramycin in cystic fibrosis patients.
Trial report in Antimicrobial agents and chemotherapy, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 6 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Intravenous antibiotics for pulmonary exacerbations in people with cystic fibrosis.The Cochrane database of systematic reviews · 2025Pooled it
- Aminoglycosides: Single- or Multiple-daily Dosing? An Updated Qualitative Systematic Review of Randomized Trials on Toxicity and Efficacy.Current molecular medicine · 2024Pooled it
- Once-daily versus multiple-daily dosing with intravenous aminoglycosides for cystic fibrosis.The Cochrane database of systematic reviews · 2019Pooled it
- Once-daily versus multiple-daily dosing with intravenous aminoglycosides for cystic fibrosis.The Cochrane database of systematic reviews · 2017Pooled it
- Intravenous antibiotics for pulmonary exacerbations in people with cystic fibrosis.The Cochrane database of systematic reviews · 2015Pooled it
- Hearing thresholds at high frequency in patients with cystic fibrosis: a systematic review.Brazilian journal of otorhinolaryngologyPooled it
- Tobramycin pharmacokinetic and pharmacodynamic targets in people with cystic fibrosis.British journal of clinical pharmacology · 2026Review
- Aminoglycosides-Related Ototoxicity: Mechanisms, Risk Factors, and Prevention in Pediatric Patients.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Aminoglycoside- and glycopeptide-induced ototoxicity in children: a systematic review.JAC-antimicrobial resistance · 2021Review
- Pharmacokinetic and Pharmacodynamic Optimization of Antibiotic Therapy in Cystic Fibrosis Patients: Current Evidences, Gaps in Knowledge and Future Directions.Clinical pharmacokinetics · 2021Review
- The cumulative effects of intravenous antibiotic treatments on hearing in patients with cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2017Article
- d-Methionine reduces tobramycin-induced ototoxicity without antimicrobial interference in animal models.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2016Article
- Extended-Interval Aminoglycoside Use in Cystic Fibrosis Exacerbation in Children and Young Adults: A Prospective Quality Improvement Project.Global pediatric health · 2016Article
- Evaluation of serum concentrations achieved with an empiric once-daily tobramycin dosage regimen in children and adults with cystic fibrosis.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2012Article
- Minimizing the toxicity of aminoglycosides in cystic fibrosis.Journal of the Royal Society of Medicine · 2010Article
- Once daily dosing of aminoglycosides in pediatric cystic fibrosis patients: a review of the literature.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2008Article
- Central auditory system assessment in children and adolescents with cystic fibrosis: electrophysiology and central auditory processing.Jornal de pediatriaArticle
- High frequency hearing thresholds and product distortion otoacoustic emissions in cystic fibrosis patients.Brazilian journal of otorhinolaryngologyObservational
- Chirp-Evoked Otoacoustic Emissions and Middle Ear Absorbance for Monitoring Ototoxicity in Cystic Fibrosis Patients.Ear and hearingArticle
- Safety of Extended Interval Tobramycin in Cystic Fibrosis Patients Less an 6 Years Old.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAGArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We undertook assessment of hearing in patients with cystic fibrosis who were taking part in a large randomized controlled trial of once- versus three-times-daily tobramycin for pulmonary exacerbations of cystic fibrosis (the TOPIC study). All patients were eligible to have standard pure tone audiometry performed across the frequency range of 0.25 to 8 kHz. High-frequency pure tone audiometry over 10 to 16 kHz was also performed with a subset of patients. Audiometry was undertaken at the start of tobramycin treatment, at the end of a 14-day course of treatment, and at follow-up 6 to 8 weeks later. We enrolled 244 patients, of whom 219 (125 children and 94 adults) completed treatment. Nineteen patients were excluded from analysis due to abnormal baseline audiometry. Complete pre- and posttreatment standard audiological data were obtained for 168/219 patients. We found no significant differences in hearing thresholds when they were assessed at the baseline, at the end of treatment, and at follow-up 6 to 8 weeks later were compared. In addition, no significant differences in hearing thresholds were detected between treatment regimens. Similar results were obtained for the subset of 63/168 patients who underwent high-frequency audiometry. We conclude that for a single 14-day course of tobramycin treatment in patients with cystic fibrosis with no preexisiting auditory deficit, no measurable effect on hearing was apparent with either once- or three-times-daily treatment. Estimation of the cumulative cochleotoxic risk in cystic fibrosis patients due to repeated aminoglycoside therapy, as evidenced by the patients excluded from this study due to hearing loss, also requires further characterization.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.