Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

NCT00429975 | Terminated Phase 4

• 1 other identifier: FIS G03/103
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumonia, Pneumococcal

Keywords

fluorquinolones,; b-lactams,; immunomodulation.

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

levofloxacin DRUG

ceftriaxone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with an acute febrile respiratory illness accompanied by a new radiographic infiltrate consistent with this diagnosis.
• and with a confirmed pneumococcal aetiology

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Hospital Mutua de Terrassa

Terrassa, BARCELONA, 08221, Spain

Location

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Interventions

Levofloxacin; Ceftriaxone

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• JAVIER GARAU, PhD

  Hospital Mutua de Terrassa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Study Start: August 1, 2004
• Study Completion: September 1, 2005
• Last Updated: February 1, 2007

Record last verified: 2007-01

Locations

ES (1)