Trial reportPloS one2012
Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00528190 (Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis), which is not on this map. Cited by 34 papers, 3 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.
Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 84 citations in OpenAlex.
- Management of Adult Bronchiectasis: Consensus-Based Guidelines of the German Respiratory Society.Respiration; international review of thoracic diseases · 2026Guideline
- Antifungal therapies for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Antifungal therapies for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.The Cochrane database of systematic reviews · 2016Pooled it
- Asthma and Allergic Bronchopulmonary Aspergillosis: Understanding, Insights, and State-of-the-Art.Journal of inflammation research · 2026Review
- Review
- The Real-World Effectiveness of Antifungals in People with Cystic Fibrosis andAnnals of the American Thoracic Society · 2025Article
- Influence of Fungal Colonization on Exacerbations in Patients with Cystic Fibrosis.Journal of fungi (Basel, Switzerland) · 2024Article
- Fungal lung disease.The European respiratory journal · 2024Review
- Pathogenicity and virulence ofVirulence · 2023Review
- Infection, Allergy, and Inflammation: The Role ofMicroorganisms · 2023Review
- The Clinical Association betweenAnnals of the American Thoracic Society · 2023Article
- Persistent Aspergillus fumigatus infection in cystic fibrosis: impact on lung function and role of treatment of asymptomatic colonization-a registry-based case-control study.BMC pulmonary medicine · 2022Article
- Clinician variability in the diagnosis and treatment of aspergillus fumigatus-related conditions in cystic fibrosis: An international survey.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022Article
- The Effects ofJournal of fungi (Basel, Switzerland) · 2021Article
- Fungal Infection and Inflammation in Cystic Fibrosis.Pathogens (Basel, Switzerland) · 2021Review
- Allergic Diseases Caused byAntibiotics (Basel, Switzerland) · 2021Review
- Bacterial Interactions withMicroorganisms · 2021Review
- Managing Fungal Infections in Cystic Fibrosis Patients: Challenges in Clinical Practice.Infection and drug resistance · 2021Review
- The IL-1 Receptor Is Required to Maintain Neutrophil Viability and Function DuringFrontiers in immunology · 2021Article
- Coinfection withEuropean respiratory review : an official journal of the European Respiratory Society · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMany patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF).
methodsWe performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18) or placebo (N = 17) for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1) and quality of life.
resultsOver the 24 week treatment period, 4 of 18 (22%) patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31%) placebo treated patients, P = 0.70. FEV(1) declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34). Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole.
conclusionWe did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients.
trial registrationClinicalTrials.gov NCT00528190.
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