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Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD--the ABACOPD study.

ABSTRACT: Antibiotic-resistant strains of pathogenic bacteria are increasingly prevalent in hospitals and the community. Acute exacerbations of COPD (AE-COPD) often result in administration of antibiotics although more than half of exacerbations are associated with detection of respiratory viruses and potentially pathogenic bacteria can only be detected in 20-30% of cases. There is a paucity of placebo-controlled clinical trials and up to today no single study has been powered sufficiently to prove the efficacy of antibiotic treatment in AE-COPD. Most studies so far did not include current standards of care comprising administration of systemic corticosteroids.A total of 980 patients with moderate acute exacerbations will be included in 22 German centers (hospitals and private practices). Patients will receive a standardized treatment for exacerbation including systemic corticosteroids, inhaled bronchodilators and supplementary oxygen if needed and will be randomized to additional treatment with placebo or antibiotic (oral sultamicillin) for five days.The primary endpoint is clinical failure defined by need for additional antibiotic treatment until day 30. Secondary endpoints will assure that management of AE-COPD without antibiotics does not result either in increased occurrence of relapse, new exacerbations, prolonged recovery, or unwanted long-term consequences.ABACOPD will be the first sufficiently powered double-blind placebo-controlled study in the field to systematically assess the question whether antibiotics, known to increase antibiotic resistance, are really needed in a well-defined patient cohort receiving state-of-the art treatment in all other aspects.ClinicalTrials.gov: NCT01892488.

SUBMITTER: Rohde GG

PROVIDER: S-EPMC4350292 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD--the ABACOPD study.

Rohde Gernot G U GG Koch Armin A Welte Tobias T

BMC pulmonary medicine 20150127

<h4>Background</h4>Antibiotic-resistant strains of pathogenic bacteria are increasingly prevalent in hospitals and the community. Acute exacerbations of COPD (AE-COPD) often result in administration of antibiotics although more than half of exacerbations are associated with detection of respiratory viruses and potentially pathogenic bacteria can only be detected in 20-30% of cases. There is a paucity of placebo-controlled clinical trials and up to today no single study has been powered sufficien ...[more]

PMID: 25623589

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Project description:BackgroundEpstein-Barr virus (EBV) frequently is measured at high levels in COPD using sputum quantitative polymerase chain reaction, whereas airway immunohistochemistry analysis has shown EBV detection to be common in severe disease.Research questionIs valaciclovir safe and effective for EBV suppression in COPD?Study design and methodsThe Epstein-Barr Virus Suppression in COPD (EViSCO) trial was a randomized double-blind placebo-controlled trial conducted at the Mater Hospital Belfast, Northern Ireland. Eligible patients had stable moderate-to-severe COPD and sputum EBV (measured using quantitative polymerase chain reaction) and were assigned randomly (1:1) to valaciclovir (1 g tid) or matching placebo for 8 weeks. The primary efficacy outcome was sputum EBV suppression (defined as ≥ 90% sputum viral load reduction) at week 8. The primary safety outcome was the incidence of serious adverse reactions. Secondary outcome measures were FEV1 and drug tolerability. Exploratory outcomes included changes in quality of life, sputum cell counts, and cytokines.ResultsFrom November 2, 2018, through March 12, 2020, 84 patients were assigned randomly (n = 43 to valaciclovir). Eighty-one patients completed trial follow-up and were included in the intention-to-treat analysis of the primary outcome. A greater number of participants in the valaciclovir group achieved EBV suppression (n = 36 [87.8%] vs n = 17 [42.5%]; P < .001). Valaciclovir was associated with a significant reduction in sputum EBV titer compared with placebo (-90,404 copies/mL [interquartile range, -298,000 to -15,200 copies/mL] vs -3,940 copies/mL [interquartile range, -114,400 to 50,150 copies/mL]; P = .002). A statistically nonsignificant 24-mL numerical FEV1 increase was shown in the valaciclovir group (difference, -44 mL [95% CI, -150 to 62 mL]; P = .41). However, a reduction in sputum white cell count was noted in the valaciclovir group compared with the placebo group (difference, 2.89 [95% CI, 1.5 × 106-7.4 × 106]; P = .003).InterpretationValaciclovir is safe and effective for EBV suppression in COPD and may attenuate the sputum inflammatory cell infiltrate. The findings from the current study provide support for a larger trial to evaluate long-term clinical outcomes.Trial registryClinicalTrials.gov; No.: NCT03699904; URL: www.Clinicaltrialsgov.

Project description:ObjectiveMost exacerbations are mild to moderate, and antibiotic treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is recommended for patients with severe exacerbations or severe underlying chronic obstructive pulmonary disease (COPD). Therefore, we aimed to investigate the patient factors that are associated with the prescription of antibiotics for inappropriate indication in AECOPD.Material and methodsThis study was an observational cross-sectional study conducted in an outpatient clinic. The patients diagnosed with AECOPD and prescribed an antibiotic by a pulmonary physician were enrolled in the study. These prescriptions were documented by the pharmacist who asked the patient about the three cardinal symptoms. Appropriate and inappropriate prescription groups were defined by the types of exacerbations, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD report.ResultsThere were 138 patients, predominantly male (83%), with a mean age of 64 (±9) years. A total of 64% of the prescriptions were appropriate; however, there were 50 (36%) patients with inappropriate antibiotic prescription according to the mentioned criteria. When we compared the patient factors between the appropriate and inappropriate antibiotic prescriptions, there was no statistically significant difference in terms of age, Forced expiratory volume in first second % (FEV1%) predicted, FEV1 ml, forced vital capacity (FVC) ml, FEV1/FVC, and amount (packs/year) of smoking (p>0.05 for all parameters). FVC% was statistically significantly lower in the appropriate antibiotic prescription group compared with that in the inappropriate antibiotic prescription group (p=0.049).ConclusionThis study shows that most pulmonary physicians have a tendency to prescribe antibiotics for AECOPD according to the defined GOLD criteria. However, some of the physicians also prefer to prescribe antibiotics self-directedly, irrespective of the GOLD criteria. A physician-based questionnaire can be completed for future studies to define the underlying reasons for antibiotic prescription demands for cases of mild AECOPD.

Project description:Background:Chronic obstructive pulmonary disease (COPD) is a chronic progressive inflammatory disease of the airways, associated with frailty, disability, co-morbidity, and mortality. Individuals with COPD experience increased risk and rates of acute exacerbation as their lung disease worsens. Current treatments to prevent acute exacerbation of COPD (AECOPD) are only modestly effective. New therapies are needed to improve the quality of life and clinical outcomes for individuals living with COPD and especially for those prone to frequent recurrent AECOPD. Recent research has suggested an association of gammaglobulin or immunoglobulin G levels with AECOPD and a favorable effect of an immunoglobulin treatment on the frequency of recurrent AECOPD, healthcare provider visits, treatments, and hospitalizations. However, control trials are required to confirm this apparent association and therapeutic effect. This study aims to assess if intravenous immunoglobulin (IVIG) therapy is feasible, safe, tolerable, and potentially effective in reducing the frequency of recurrent AECOPD. Methods/design:Adult COPD patients at The Ottawa Hospital (TOH) will be recruited to partake in a randomized double-blind, parallel, two-arm, placebo control trial. Eligible patients will be administered either IVIG or normal saline following 1:1 randomization and every 4 weeks for 1 year. The primary outcome of feasibility will be determined by recruitment, patient adherence, safety and tolerance, success of the follow-up procedures, and outcome measurement. The safety and tolerability will be assessed through adverse events, adherence, and study withdrawals. Efficacy trends will be investigated by assessing incidence rates of AECOPD, improvement in quality of life, and healthcare services use and cost. Discussion:The study results will inform larger studies designed to confirm a clinically significant therapeutic effect in identifiable populations which would be a major advance in the care of COPD patients. Trial registration number:ClinicalTrial.gov, NCT03018652 and NCT02690038.

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Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD--the ABACOPD study.

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Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD--the ABACOPD study.

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