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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00429975 |
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Date of registration:
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31/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia
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Scientific title:
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Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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45 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00429975 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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EVA CUCHI, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Mutua de Terrassa |
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Name:
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JAVIER GARAU, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Mutua de Terrassa |
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Name:
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MONTSERRAT ALSINA, MD |
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Address:
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Email:
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Affiliation:
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HOSPITAL MUTUA TERRASSA |
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Name:
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ESTHER CALBO, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Mutua de Terrassa |
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Name:
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MARIONA XERCAVINS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Mutua de Terrassa |
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Name:
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MONICA RODRIGUEZ-CARBALLEIRA, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Mutua de Terrassa |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients with an acute febrile respiratory illness accompanied by a new radiographic
infiltrate consistent with this diagnosis.
- and with a confirmed pneumococcal aetiology
Exclusion Criteria:
- age < 18 years,
- pneumonia distal to endobronchial obstruction,
- pulmonary tuberculosis,
- bronchiectasis,
- known allergy to B-lactams or fluoroquinolones,
- underlying systemic autoimmune disease
- immunocompromised states including patients on maintenance oral corticosteroids, HIV
infection,
- pregnancy,
- patients that received antimicrobial therapy in the 15 days preceding the current
episode and those who had received fluoroquinolones in the last month, or non
steroidal anti-inflammatory therapy in the last two weeks.
- Patients with renal failure (serum creatinine > 2 mg / dL),
- and patients with a documented pneumococcal pneumonia in the previous 4 weeks
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pneumonia, Pneumococcal
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Intervention(s)
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Drug: ceftriaxone
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Drug: levofloxacin
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Primary Outcome(s)
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Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion
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Secondary Outcome(s)
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the relationship between cytokine expression, clinical variables and severity of disease.
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Secondary ID(s)
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FIS G03/103
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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