Trial reportArchives of pediatrics & adolescent medicine2011
Comparative efficacy and safety of 4 randomized regimens to treat early Pseudomonas aeruginosa infection in children with cystic fibrosis.
Trial report in Archives of pediatrics & adolescent medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00097773 (Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis), which is not on this map. Cited by 85 papers, 8 of them syntheses that pooled 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.
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.
Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis
Who cites it
85 citing papers in PubMed, 8 syntheses or guidelines pooled it, 212 citations in OpenAlex.
- Eradication treatment forEuropean respiratory review : an official journal of the European Respiratory Society · 2024Pooled it
- Brazilian guidelines for the pharmacological treatment of the pulmonary symptoms of cystic fibrosis. Official document of the Sociedade Brasileira de Pneumologia e Tisiologia (SBPT, Brazilian Thoracic Association).Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2023Guideline
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Treatments for preventing recurrence of infection with Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2019Pooled it
- Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2018Pooled it
- Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis.The Cochrane database of systematic reviews · 2017Pooled it
- Oral anti-pseudomonal antibiotics for cystic fibrosis.The Cochrane database of systematic reviews · 2016Pooled it
- Cystic Fibrosis Microbiome-directed Antibiotic Therapy Trial in Exacerbations Results Stratified (CFMATTERS): results of a multicentre randomised controlled trial.The European respiratory journal · 2025Trial
- Association of Intensity of Antipseudomonal Antibiotic Therapy With Risk of Treatment-Emergent Organisms in Children With Cystic Fibrosis and Newly Acquired Pseudomonas Aeruginosa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Intravenous versus oral antibiotics for eradication of Pseudomonas aeruginosa in cystic fibrosis (TORPEDO-CF): a randomised controlled trial.The Lancet. Respiratory medicine · 2020Trial
- Methicillin-resistant Staphylococcus aureus eradication in cystic fibrosis patients: A randomized multicenter study.PloS one · 2019Trial
- Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial.American journal of respiratory and critical care medicine · 2018Trial
- Impact of Sustained Eradication of New Pseudomonas aeruginosa Infection on Long-term Outcomes in Cystic Fibrosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015Trial
- Risk of hemoptysis in cystic fibrosis clinical trials: A retrospective cohort study.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2015Trial
- Pseudomonas aeruginosa phenotypes associated with eradication failure in children with cystic fibrosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014Trial
- Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.Pediatric pulmonology · 2013Trial
- Pseudomonas aeruginosa serology and risk for re-isolation in the EPIC trial.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2013Trial
- Incidence and clinical significance of elevated liver function tests in cystic fibrosis clinical trials.Contemporary clinical trials · 2013Trial
- Risk factors for age at initial Pseudomonas acquisition in the cystic fibrosis epic observational cohort.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2012Trial
25 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
17 authors at 8 institutions in 2 countries.
Funding
Abstract
objectiveTo investigate the efficacy and safety of 4 antipseudomonal treatments in children with cystic fibrosis with recently acquired Pseudomonas aeruginosa infection.
designRandomized controlled trial.
settingMulticenter trial in the United States.
participantsThree hundred four children with cystic fibrosis aged 1 to 12 years within 6 months of P aeruginosa detection.
interventionsParticipants were randomized to 1 of 4 antibiotic regimens for 18 months (six 12-week quarters) between December 2004 and June 2009. Participants randomized to cycled therapy received tobramycin inhalation solution (300 mg twice a day) for 28 days, with oral ciprofloxacin (15-20 mg/kg twice a day) or oral placebo for 14 days every quarter, while participants randomized to culture-based therapy received the same treatments only during quarters with positive P aeruginosa cultures.
main outcome measuresThe primary end points were time to pulmonary exacerbation requiring intravenous antibiotics and proportion of P aeruginosa -positive cultures.
resultsThe intention-to-treat analysis included 304 participants. There was no interaction between treatments. There were no statistically significant differences in exacerbation rates between cycled and culture-based groups (hazard ratio, 0.95; 95% confidence interval [CI], 0.54-1.66) or ciprofloxacin and placebo (hazard ratio, 1.45; 95% CI, 0.82-2.54). The odds ratios of P aeruginosa- positive culture comparing the cycled vs culture-based group were 0.78 (95% CI, 0.49-1.23) and 1.10 (95% CI, 0.71-1.71) comparing ciprofloxacin vs placebo. Adverse events were similar across groups.
conclusionsNo difference in the rate of exacerbation or prevalence of P aeruginosa positivity was detected between cycled and culture-based therapies. Adding ciprofloxacin produced no benefits.
trial registrationClinicalTrials.gov Identifier: NCT00097773.
Indexed as
Identifiers
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.