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Efficacy and safety of sequential moxifloxacin IV / PO compared to levofloxacin IV plus ceftriaxone IV followed by PO levofloxacin, in the treatment of patients with community-acquired pneumonia.

MULTINATIONAL, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE THE EFFECTIVENESS AND SECURITY OF THE INTRAVENOUS / ORAL SEQUENTIAL MOXIFLOXACINE COMPARED WITH INTRAVENOUS CEFTRIAXONE MORE INTRAVENOUS LEVOFLOXACINE FOLLOWED BY ORAL LEVOFLOXACIN, IN THE TREATMENT OF PATIENTS WITH SEVERE PNEUMONIA ACQUIRED IN THE COMMUNITY.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-094-03
Enrollment
Unknown
Registered
2003-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Moxifloxacin Type of group
Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039) Group name:Levofloxacin + Ceftriaxone Type of group
Intravenous combination therapy of levofloxacin 500 mg twice daily and ceftriaxone (2 g once a day) followed by oral levofloxacin (500 mg twice a day for 7 to 14 days).

Sponsors

BAYER S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients 18 years of age or older. All the signs and symptoms of pneumonia. Fine Score> 71 Informed written consent obtained from the patient or legal representative.

Exclusion criteria

Exclusion criteria: Known hypersensitivity to fluoroquinolones, or other quinolones, and / or to beta-lactams, and / or to macrolide antibiotic medications. Female patients who are pregnant or breastfeeding. Antecedents of disease / tendon alteration related to treatment with fluroquinolones.

Design outcomes

Primary

MeasureTime frame
Outcome name:The clinical response to the study medication will be defined as follows: Improvement, failure, indeterminate and cure. Measure:Evaluation of clinical efficacy Timepoints:5 day—

Secondary

MeasureTime frame
Outcome name:The critical events committee will blindly assess and fail on all cardiac clinical events and indications of QT prolongation. Measure:Clinical safety assessment Timepoints:5 day—

Countries

France, Italy, Peru, Portugal, Spain, United Kindgdom, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)