Evidence map›Paper›PMID 9713009›Full record

Trial reportArchives of disease in childhood1998

Efficacy, tolerance, and pharmacokinetics of once daily tobramycin for pseudomonas exacerbations in cystic fibrosis.

P Vic, S Ategbo, D Turck, M O Husson, V Launay, G A Loeuille, A Sardet, A Deschildre, D Druon, C Arrouet-Lagande

Open access · bronzeAbstract readClinical TrialComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of disease in childhood, 1998. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 5 pooled it
6.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 5 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
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  6. Trial
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  10. Review
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  12. Article
  13. Duration of intravenous antibiotic therapy in people with cystic fibrosis.The Cochrane database of systematic reviews · 2016
    Review
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  15. Review
  16. Article
  17. Article
  18. 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 · 2012
    Article
  19. National survey of extended-interval aminoglycoside dosing in pediatric cystic fibrosis pulmonary exacerbations.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2011
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

P VicDepartment of Paediatrics, Lille University Hospital, France.
S Ategbo
D Turck
M O Husson
V Launay
G A Loeuille
A Sardet
A Deschildre
D Druon
C Arrouet-Lagande
Université de Lille · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare once daily with thrice daily tobramycin for treatment of Pseudomonas aeruginosa infection in patients with cystic fibrosis.

design22 patients with cystic fibrosis, mean (SD) age 11 (3.4) years (range 5.6-19.3), with pulmonary pseudomonas exacerbations were randomly assigned to receive a 14 day course of tobramycin (15 mg/kg/day) either in three infusions (group A) (n = 10) or a single daily infusion (group B) (n = 12), combined with ceftazidime (200 mg/kg/day as three intravenous injections). Efficacy was assessed by comparison of pulmonary, nutritional, and inflammatory indices on days 1 and 14. Cochlear and renal tolerance were assessed on days 1 and 14. Tobramycin concentration was measured in serum and sputum 1, 2, 3, 4, 8, and 24 hours after the start of the infusion. Analysis was by non-parametric Wilcoxon test.

resultsVariables improving (p < 0.05) in both groups A and B were, respectively: weight/height (+4% and +3.1%), plasma prealbumin (+66 and +63 mg/l), forced vital capacity (FVC) (+14% and +11%), forced expiratory volume in one second (+15% and +14%), and forced expiratory flow between 25% and 75% of FVC (+13% and +21%). Improvement was not significantly different between groups. Renal and cochlear indices remained within the normal range. Serum peak concentration of tobramycin on day 1 was 13.2 (7.1) mg/l in group A and 42.5 (11.2) mg/l in group B (p < 0.001); serum trough was 1.1 (0.8) mg/l in group A and 0.3 (0.2) mg/l in group B (p < 0.01). Tobramycin concentrations in sputum were two to three times higher in group B than group A.

conclusionsOnce daily tobramycin combined with three injections of ceftazidime is safe and effective for the treatment of pseudomonas exacerbations in cystic fibrosis patients.

Indexed as

AdolescentAdultAnti-Bacterial AgentsCeftazidimeCephalosporinsChildChild, PreschoolCystic FibrosisDrug Administration ScheduleFemaleHumansInfusions, IntravenousInjections, IntravenousMalePseudomonas InfectionsSputumAnti-Bacterial AgentsCeftazidimeCephalosporinsTobramycin

Identifiers

PMID9713009
PMCPMC1717599
OpenAlexW1982069984

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.