Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00538018
First received: October 1, 2007
Last updated: February 15, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pneumonia |
Drug: Telithromycin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Sanofi:
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) ]
| Enrollment: | 978 |
| Study Start Date: | January 2003 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00538018 History of Changes |
| Other Study ID Numbers: | HMR3647A_4015 |
| Study First Received: | October 1, 2007 |
| Last Updated: | February 15, 2012 |
| Health Authority: | Thailand: Khon Kaen University Ethics Committee for Human Research |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Telithromycin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013