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Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00538018
Collaborator
(none)
978
Enrollment
17
Duration (Months)

Study Details

Study Description

Brief Summary

Demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed by local guidelines ("usual care") for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high bacterial resistance areas.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
978 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Jun 1, 2004
Actual Study Completion Date :
Jun 1, 2004

Outcome Measures

Primary Outcome Measures

  1. To compare the effect of telithromycin versus "usual care" on the total symptoms score of pneumonia and on health outcomes, in CAP adult outpatients at the end of therapy visit. [(Days 8-11)]

Secondary Outcome Measures

  1. For health outcomes at the test of cure visit; e.g. additional LRTI-related antibiotic use, LRTI related hospitalization with length of stay and LRTI related office visit/emergency room visit. [(Days 17-21)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult outpatients with mild to moderate CAP. Diagnosis of CAP was based on the presence of fever and/or hyperleucocytosis and the new and sudden onset of at least two clinical signs and symptoms of pneumonia (cough, dyspnea or tachypnea, chills, pleuritic chest pain, purulent sputum or change in sputum character, auscultatory findings). Clinical diagnosis of CAP had to be confirmed by chest X-ray findings (e.g. presence of presumably new infiltrate). Specimens for microbiological documentation had to be collected within 24 hours prior to enrollment.
Exclusion Criteria:

  • Subjects requiring parenteral antibiotic treatment.

  • Subjects with severe CAP requiring hospitalization. The CAP was to be considered as severe in the presence of any of the following conditions:

  • chest X-ray showing a multilobar consolidation (> 1 lobe)3 and/ or an increase in the size of the opacity by greater than or = to 50% within 48 hours of the current evaluation

  • shock

  • altered mental status (disorientation to person, place or time that is not known to be chronic, lethargy, stupor or coma)

  • total peripheral white blood cell count < 4,000/mm3

  • requirement for mechanical ventilation

  • requirement for vasopressors

  • acute renal failure

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00538018
Other Study ID Numbers:
  • HMR3647A_4015
First Posted:
Oct 2, 2007
Last Update Posted:
Feb 17, 2012
Last Verified:
Feb 1, 2012
Additional relevant MeSH terms:
Pneumonia
Telithromycin

Study Results

No Results Posted as of Feb 17, 2012