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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 15, 2005 | ||||
| Last Updated Date | March 13, 2007 | ||||
| Start Date ICMJE | August 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
A 20% reduction of the duration of clinical symptoms of exacerbation is expected | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00190437 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD | ||||
| Official Title ICMJE | ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD | ||||
| Brief Summary | Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU. The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD ) |
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| Detailed Description | This is a multicenter, randomised, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Obstructive Lung Disease (COLD) | ||||
| Intervention ICMJE | Drug: Amoxicillin-clavulanic | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 520 | ||||
| Completion Date | October 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00190437 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | P010310, AOM01075, ANTEAB | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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