Antibiotic or Not in Non-purulent Exacerbations of COPD:... | NCT01091493

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

NCT01091493

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Status

Completed

Last Update Posted

Jul 6, 2018Actual

Enrollment

73Actual

Phase

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Moxifloxacin

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 5, 2018Actual

Completion Date

Jul 5, 2018Actual

First Submitted Date

Mar 19, 2010

First Submission Date that Met QC Criteria

Mar 23, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2018

Last Update Posted Date

Jul 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nestor Soler Porcar, MD, PhD, Especialista Senior, Fundacion Clinic per a la Recerca BiomédicaPrincipal Investigator

Lead Sponsor

Fundacion Clinic per a la Recerca BiomédicaOTHER

Collaborators

Name	Class
Instituto de Salud Carlos III	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Antibiotic	No Intervention	Patients will not receive antibiotics, although the study is double-blind.
Antibiotic	Active Comparator	Patients will receive in a masked way, moxifloxacin.	Drug: Moxifloxacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moxifloxacin	Drug	Moxifloxacin 400 mg administered once a day for 5 days	Antibiotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD		Six months

Secondary Outcomes

Measure	Description	Time Frame
Efficacy/Safety in treatment on re-hospitalizations at six months.		Six monts
In-hospital stay (days)		Six months
All cause mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nestor Soler, MD,PhD	Hospital Clinic of Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Miquel Servet		Zaragoza	Aragon	50009	Spain
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17630021	Background	Murray CJ, Lopez AD, Black R, Mathers CD, Shibuya K, Ezzati M, Salomon JA, Michaud CM, Walker N, Vos T. Global burden of disease 2005: call for collaborators. Lancet. 2007 Jul 14;370(9582):109-110. doi: 10.1016/S0140-6736(07)61064-2. No abstract available.
8887592	Background	Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines