Telithromycin in Respiratory Tract Infections

NCT00261105 | Completed Phase 4

• 1 other identifier: HMR3647A_4026
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary Objectives:

• The primary objective of the study is to evaluate clinical efficacy i.e. to show that with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community acquired respiratory tract infections: community acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in outpatients. Secondary Objectives: The secondary objectives are to:
• Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which additional antibacterials were prescribed to treat the primary infection; the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data, chest X-ray and sinus X-ray if available.
• Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Clinical Outcome (Global Assessment by the participating physicians)

  During the Study Conduct

Secondary Outcomes (4)

• Rate at which additional antibacterials were prescribed to treat the primary infection

  During the study conduct

• Rate of hospitalisation due to a complication of the primary infection

  During the study conduct

• Assessment of chest X-ray and sinus X-ray if available.

  During the study conduct

• Adverse Event (AE) and Serious Adverse Event (SAE) reported

  from the inform consent signed up to the end of the study

Interventions

telithromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General Conditions
• Outpatients
• Fulfillment of clinical diagnostic criteria for one of the following indications:
• Mild to moderate Community Acquired Pneumonia (CAP)
• Acute bacterial Exacerbation of Chronic Bronchitis (AECB)
• Acute Sinusitis (AS)
• For CAP
• The Criteria to be fulfilled are:
• New onset of at least two of the following:
• Cough
• Production of purulent sputum
• Auscultatory findings compatible with pneumonia, e.g. rales, evidence of pulmonary consolidation
• Dyspnea or tachypnea
• Fever
• Elevated total white blood cell count \> 10 000/mm3 or \>15% bands regardless of total count

You may not qualify if:

• General Conditions
• Subjects presenting with any of the following will not be included in the study:
• Treatment required during the study with ergot alkaloid derivatives, pimozide, astemizole, terfenadine, cisapride, simvastatin, atorvastatin and lovastatin, and the oral use of the benzodiazepines midazolam, triazolam and alprazolam.
• History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation.
• Known hypersensitivity to telithromycin or to macrolide antibiotics.
• Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry).
• Pregnant or breast-feeding women. For the women of childbearing potential it is left to the investigators discretion to establish a lack of pregnancy, e.g. with contraceptive use, menstrual pattern, urinary pregnancy test.
• Subjects with severely impaired renal function (creatinine clearance \<30 ml/min).
• Subjects that had received anti-bacterials for more than 24 hours within 7 days prior to enrollment in the study, unless the treatment has failed.
• Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation.
• Infection, other than the primary infection for which the subject is being included in the study that requires use of other systemic anti-bacterial drug.
• Splenectomised subjects.
• Use of Ketek® (telithromycin) or participation in a study using Ketek® (telithromycin) in the previous 30 calendar days.
• Subjects that have received any investigational drug within 4 weeks of enrollment in the study.
• No subject will be allowed to enroll in this study more than once.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

telithromycin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Won-Sik Lee, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2005
• First Posted: December 2, 2005
• Study Start: February 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: December 1, 2005
• Last Updated: September 25, 2009

Record last verified: 2009-09