Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia - Full Text View

Sponsor:	Hospital Mutua de Terrassa
Collaborator:	Fondo de Investigacion Sanitaria
Information provided by:	Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier:	NCT00429975

Purpose

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

Condition	Intervention	Phase
Pneumonia, Pneumococcal	Drug: levofloxacin Drug: ceftriaxone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison Between Ceftriaxone and Levofloxacin on Cytokine Expression Over Time in Severe Pneumococcal Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Ceftriaxone Ceftriaxone Sodium Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Hospital Mutua de Terrassa:

Primary Outcome Measures:

Circulating levels of pro and anti-inflammatory cytokines at 0h, 24, 72 h and 120 h from inclusion

Secondary Outcome Measures:

the relationship between cytokine expression, clinical variables and severity of disease.

Estimated Enrollment:	45
Study Start Date:	August 2004
Estimated Study Completion Date:	September 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429975

Locations

Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221

Sponsors and Collaborators

Hospital Mutua de Terrassa

Fondo de Investigacion Sanitaria

Investigators

Principal Investigator:	ESTHER CALBO, MD	Hospital Mutua de Terrassa
Principal Investigator:	MONTSERRAT ALSINA, MD	HOSPITAL MUTUA TERRASSA
Principal Investigator:	MARIONA XERCAVINS, MD	Hospital Mutua de Terrassa
Principal Investigator:	EVA CUCHI, MD	Hospital Mutua de Terrassa
Principal Investigator:	MONICA RODRIGUEZ-CARBALLEIRA, PhD	Hospital Mutua de Terrassa
Study Director:	JAVIER GARAU, PhD	Hospital Mutua de Terrassa

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00429975 History of Changes
Other Study ID Numbers:	FIS G03/103
Study First Received:	January 31, 2007
Last Updated:	January 31, 2007
Health Authority:	SPAIN: AGEMED (Agencia Española del Medicamento y Productos Sanitarios.

Keywords provided by Hospital Mutua de Terrassa:

fluorquinolones,
b-lactams,
immunomodulation.

Additional relevant MeSH terms:

Pneumonia
Pneumonia, Pneumococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Ceftriaxone

Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on February 09, 2012