Clinical Trial: Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis or Mild Community-acquired This PMOS will be conducted in a prospective, open-label, single-country, multicenter format. The investigational sites will be consulting rooms of GPs (general practitioner), pneumologists and centers with experience in the treatment of patients with lower respiratory tract infection, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a PMOS, Klacid®SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not prescribe Klacid®SR would be taken prior to entry of a subject in the study.

Follow-up of patients should enable two patient visits during this period. Screening/Inclusion Visit will be performed when the decision to start the treatment with Klacid®SR is made. Inclusion of patient in the study will succeed at day 0 (S/I Visit). The Second Visit will follow 10 - 16 days after the Screening/Inclusion Visit.

Current Primary Outcome:

• Compliance (Was the Dosage Followed - Yes, no) [ Time Frame: Day 10 - 16 ]
  Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.
• The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events [ Time Frame: Day 0 through Days 10 - 16 ]
  The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details.

Original Primary Outcome:

• Compliance (was the dosage followed - yes, no; duration of therapy - days) [ Time Frame: Day 10 - 16 ]
• The tolerability of Klacid®SR will be assessed by evaluation of adverse events [ Time Frame: Day 0 ]
• The tolerability of Klacid®SR will be assessed by evaluation of adverse events [ Time Frame: Day 10 - 16 ]

Current Secondary Outcome:

• Body Temperature [ Time Frame: Day 0 ]
  Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Day 0 (Baseline) is summarized.
• Body Temperature [ Time Frame: Day 10 - 16 ]
  Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Visit 2 is summarized.
• Cough and Its Character [ Time Frame: Day 0 ]
  Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Baseline is presented.
• Cough and Its Character [ Time Frame: Day 10 - 16 ]
  Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Visit 2 is presented.
• Dyspnoea [ Time Frame: Day 0 ]
  Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Baseline is presented.
• Dyspnoea [ Time Frame: Day 10 - 16 ]
  Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Visit 2 is presented.
• Auscultation [ Time Frame: Day 0 ]
  Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Baseline is summarized.
• Auscultation [ Time Frame: Day 10 - 16 ]
  Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Visit 2 is summarized.

Original Secondary Outcome:

• Body Temperature [ Time Frame: Day 0 ]
• Body Temperature [ Time Frame: Day 10 - 16 ]
• Cough and Its Character [ Time Frame: Day 0 ]
• Cough and Its Character [ Time Frame: Day 10 - 16 ]
• Dyspnoea [ Time Frame: Day 0 ]
• Dyspnoea [ Time Frame: Day 10 - 16 ]
• Auscultation [ Time Frame: Day 0 ]
• Auscultation [ Time Frame: Day 10 - 16 ]

Dates:
Date Received: April 20, 2010
Date Started: March 2010
Date Completion:
Last Updated: September 9, 2011
Last Verified: September 2011