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NCT Number: NCT01091493

Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy

COPD is one of the most important causes of morbidity and mortality and supposes a sanitary problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation of COPD (AECOPD) per year, being these the principal causes of of hospitalizations, respiratory problems and medical visits. After an episode of AECOPD, the majority of patients develop a transitory (or permanent) worsening in their quality of life and 50% of them will require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an evidence of viral infection could be documented. Even though the antibiotic treatment might not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD results in a very expensive disease and raises the rate of resistance of bacteria. The available literature have shown that there's a relation between exacerbations and infections, based on sputum samples.

In summary, is well known that at least a 50% of the episodes of AECOPD might be associated with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide and generalized in hospitalized patients. Clinical trials have shown correlation between AECOPD with sputum purulence (which correlates with presence of bacteria), however they've not included NON-purulent AECOPD, even though they're a significative group of patients hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of antibiotic treatment in this group of patients in a well designed trial.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Miquel Servet, Zaragoza, Aragon, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD diagnosis according to GOLD guidelines
  • Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease
  • Failure of outpatient treatment
  • Increasing of dyspnea in the last days
  • Comorbidity that causes detriment of respiratory function

Exclusion criteria

  • Life expectancy of less than 6 months
  • Mechanical Ventilation
  • Cardiovascular condition that causes exacerbation
  • Immunosuppression
  • Pulmonary infiltrates that suggest pneumonia
  • Antibiotic treatment in the last month
  • Pregnancy
  • ECG with a large QT segment
  • Hypokalemia
  • Hepatic failure or renal failure

Treatment and study plan

moxifloxacin

Drug

Moxifloxacin 400 mg administered once a day for 5 days

Other names: Actira

Primary outcomes

  1. Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD

    Time frame: Six months

Secondary outcomes

  1. Efficacy/Safety in treatment on re-hospitalizations at six months.

    Time frame: Six monts

  2. In-hospital stay (days)

    Time frame: Six months

  3. All cause mortality

    Time frame: One and Six months

  4. Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire

    Time frame: Hospitalization day 1 and six months

    This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ)

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy

Acronym: AEPOC-ATB

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2010
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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