Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas
This study has been completed.
Information provided by (Responsible Party):
First received: October 1, 2007
Last updated: February 15, 2012
Last verified: February 2012
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.
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
- 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 Outcome Measures:
- 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) ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2004 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538018
||Clinical Sciences & Operations
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 1, 2007
||February 15, 2012
||Thailand: Khon Kaen University Ethics Committee for Human Research
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 23, 2014
Respiratory Tract Diseases
Respiratory Tract Infections