Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

NCT ID: NCT00429975

Last Updated: 2007-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-09-30

Brief Summary

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The purpose of this study is to compare levofloxacin vs ceftriaxone impact on the cytokine production in patients with pneumococcal pneumonia.

Detailed Description

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Bacterial alveolar invasion is followed by a compartmentalized inflammatory response. Data suggest that some antimicrobials may induce a differential release of cytokines, with the potential of either accelerating or down regulating cytokine production.

The aim of our study was to compare the effects of ceftriaxone compared with levofloxacin on cytokine systemic concentrations in patients with pneumococcal pneumonia.

Conditions

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Pneumonia, Pneumococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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levofloxacin

Intervention Type DRUG

ceftriaxone

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondo de Investigacion Sanitaria

OTHER

Sponsor Role collaborator

Hospital Mutua de Terrassa

OTHER

Sponsor Role lead

Principal Investigators

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ESTHER CALBO, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Mutua de Terrassa

MONTSERRAT ALSINA, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL MUTUA TERRASSA

MARIONA XERCAVINS, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Mutua de Terrassa

EVA CUCHI, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Mutua de Terrassa

MONICA RODRIGUEZ-CARBALLEIRA, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Mutua de Terrassa

JAVIER GARAU, PhD

Role: STUDY_DIRECTOR

Hospital Mutua de Terrassa

Locations

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Hospital Mutua de Terrassa

Terrassa, BARCELONA, Spain

Site Status

Countries

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Spain

Other Identifiers

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FIS G03/103

Identifier Type: -

Identifier Source: org_study_id

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