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Clarithromycin Study for Evaluation of Treatment, Safety & Recovery Time of Respiratory Tract Infection (RTI) in Saudi Clinical Setting (CLOSER)

2014-07-23 21:10:00 | BioPortfolio

Summary

Clarithromycin Observational Study for Evaluation of treatment, Safety & Recovery Time of Respiratory Tract Infection in Saudi Clinical Setting (CLOSER)

Description

The objective is to describe the effectiveness, measured by clinical success and the recovery time of symptoms (cough, mucus, fever and sore throat), tolerability and compliance of treatment with Klacid XL once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.

Primary endpoints:

- Time to the resolution of cough and other symptoms. Time to recovery was defined as the number of days required for the patient to return to baseline after initiation of Klacid XL therapy.

- Baseline is defined as the the symptom status prior the onset of RTI. This status is based on the patient & physician assessment. Fast recovery is defined as the resolution of symptoms in less than or equal to 5 days from the start of Klacid XL treatment. Secondary endpoints:

- Adverse Events:record the number, symptoms and severity of adverse events for Klacid XL. The action taken, outcome and relationship to Klacid XL treatment should be addressed.

- Percentage of treatment failure:defined as failure to return to baseline before 10 days or the requirement of new treatments or medications during the first 10 days for persistence or aggravation of symptoms.

- Factors affecting the speed of recovery:identifying variables independently and significantly associated with the speed of recovery.

- Individual Clinical outcomes of treatment:

1. Body temperature (highest temperature; duration of temperature over 37.0 degree of Celsius in days, oral measurement)

2. Cough and its character (present or not; type of cough:productive, irritating; duration; all reported by the patient)

3. Dyspnoea (type of dyspnoea:after exercise, rest; duration; reported by the patient)

4. Auscultation findings (normal, abnormal - wheezing, crackles),

5. Mucus production (yes - disappearance or significant decrease of mucus amount and / or viscosity, no),

6. Adverse Events (no, yes - description),

7. Compliance (treatment was followed in both dosage and duration - yes, no),

8. Termination of treatment (planned, premature - reason).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Conditions

Respiratory Tract Infection

Intervention

clarithromycin (Klacid XL)

Status

Not yet recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:00-0400

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