NCT Number: NCT00538018
Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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.
Time frame: (Days 8-11)
Secondary outcomes
-
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.
Time frame: (Days 17-21)
Sponsors and collaborators
Lead sponsor
Sanofi
Industry
Registry information
Important dates
- Study start
- 2003
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Oct 2, 2007
- Registry last updated
- Feb 17, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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