Trial reportThorax1996
Minimisation of aminoglycoside toxicity in patients with cystic fibrosis.
Trial report in Thorax, 1996. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 8 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
14 citing papers in PubMed, 8 syntheses or guidelines pooled it, 53 citations in OpenAlex.
- Intravenous antibiotics for pulmonary exacerbations in people with cystic fibrosis.The Cochrane database of systematic reviews · 2025Pooled it
- Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Once-daily versus multiple-daily dosing with intravenous aminoglycosides for cystic fibrosis.The Cochrane database of systematic reviews · 2019Pooled it
- Eradication therapy for Burkholderia cepacia complex in people with cystic fibrosis.The Cochrane database of systematic reviews · 2019Pooled it
- Treatment for chronic methicillin-sensitive Staphylococcus aureus pulmonary infection in people with cystic fibrosis.The Cochrane database of systematic reviews · 2018Pooled it
- Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis.The Cochrane database of systematic reviews · 2018Pooled 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
- Tobramycin pharmacokinetic and pharmacodynamic targets in people with cystic fibrosis.British journal of clinical pharmacology · 2026Review
- Defining the Importance of Age-Related Changes in Drug Clearance to Optimizing Aminoglycoside Dosing Regimens for Adult Patients with Cystic Fibrosis.European journal of drug metabolism and pharmacokinetics · 2022Article
- Changes in the inner ear structures in cystic fibrosis patients.International journal of pediatric otorhinolaryngology · 2017Article
- Occurrence and risk of cochleotoxicity in cystic fibrosis patients receiving repeated high-dose aminoglycoside therapy.Antimicrobial agents and chemotherapy · 2001Article
- Pharmacokinetic optimisation of antibacterial treatment in patients with cystic fibrosis. Current practice and suggestions for future directions.Clinical pharmacokinetics · 1998Review
- Changes in MIC alter responses of Pseudomonas aeruginosa to tobramycin exposure.Antimicrobial agents and chemotherapy · 1998Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is evidence that administration of higher doses of aminoglycosides given less frequently improves the bactericidal effect and reduces the potential to cause side effects. To investigate this, a prospectively randomised open label therapeutic trial was undertaken in stratified groups of patients with cystic fibrosis to examine the efficacy and toxic potential of an aminoglycoside dosing regimen designed to generate high peak drug concentrations at 12 hourly intervals compared with conventional dosing at eight hourly intervals.
methodsPatients in group A received tobramycin eight hourly using a dose aimed at generating a peak concentration of 10 mg/l with trough concentrations below 2 mg/l, and those in group B received the total daily dose required to achieve eight hourly target concentrations administered as two equal 12 hourly doses. Clinical outcomes measured and assessed included vestibular symptoms, hearing and renal function, length of hospital stay, readmission rate, and mortality.
resultsTwenty nine patients were recruited during a six month period, 20 to group A and nine to group B. The average peak tobramycin level was higher in group B (12.5 (2.2) mg/l) than in group A (7.9 (1.9) mg/l), whilst the average trough level was higher in group A (0.8 (0.3) mg/l) than in group B (0.5 (0.2) mg/l). There was a difference in the number of ototoxic events between patients in group A (seven of 18, 38.9%) and group B (none of eight), but no difference was found in other outcome measures assessed.
conclusionsThese results suggest that 12 hourly high peak aminoglycoside dosing may be less toxic than equivalent eight hourly dosing, without any apparent difference in efficacy.
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What OpenQuestion holds
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.