Clinical trial NCT00717561: A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia
Official title: A National, Prospective, Randomized, Open Label Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin vs IV Ceftriaxone + IV Azithromycin Followed by PO Amoxicilline/Clavulanate and PO Clarithromycin in Subjects With Community-acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: CAP
Community-acquired pneumonia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.


Eligibility criteria: Inclusion Criteria:

* Hospitalized non-ICU patients (age, \>= 18 years)
* Clinical signs and symptoms of CAP, with PSI score IV or V
* Radiologically confirmed evidence of a new and/or progressive infiltrate(s)
* Requirement for initial parenteral therapy
* At least 2 of the following conditions:

  * Productive or non productive cough with or without purulent or mucosus or mucopurulent sputum
  * Dyspnea and/or tachypnea (respiratory rate of \> 20 breaths/min)
  * Rigors and/or chills
  * Pleuritic chest pain
  * Auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation
  * Fever (an oral temperature of \>= 38 °C, a rectal temperature of \>= 39 °C, or a tympanic temperature of \>= 38.5 °C) or hypothermia (rectal or core temperature of \< 35 °C), and a WBC count of \>= 10,000 cells/mm3 or \>= 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of \< 4500 cells/mm3)
* Written informed consent

Exclusion Criteria:

* PSI Class I-III and V with need for ICU admission
* Hospitalization for \> 48 hours before developing pneumonia, or discharge from hospital \< 30 days prior. Note: patients currently residing in residential long-term facilities can be enrolled in the study

Primary outcomes:
measure: Clinical response 20 days after completion of study treatment (Test-of-Cure visit)
timeFrame: 20 days after last dose of study drug (TOC Visit)
Secondary outcomes:
measure: Clinical and bacteriological response on the day of switch from IV to oral therapy
timeFrame: Day of switch from IV to oral therapy
measure: Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5)
timeFrame: Day 3-5
measure: Bacteriological response at TOC
timeFrame: 20 days after last dose of study drug
measure: Clinical and bacteriological response at the end of treatment
timeFrame: Day 7-14 after first dose of study drug
measure: Mortality attributable to pneumonia at the Test-of-Cure visit
timeFrame: 20 days after last dose of study drug
Other outcomes:
Locations:
city: Lungro
country: Italy
state: Cosenza
city: San Cesario
country: Italy
state: Lecce
city: Fossombrone
country: Italy
state: Pesaro e Urbino
city: Pregiato di Cava dei Tirreni
country: Italy
state: Salerno
city: Vittorio Veneto
country: Italy
state: Treviso
city: Ascoli Piceno
country: Italy
city: Benevento
country: Italy
city: Brescia
country: Italy
city: Catania
country: Italy
city: Chieti
country: Italy
city: Foggia
country: Italy
city: Lucca
country: Italy
city: Macerata
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Palermo
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Sassari
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: