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

Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis or Mild Community-acquired Bronchopneumonia in Common Clinical Practice in the Slovak Republic

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01108185

Enrollment

3181

Registered

2010-04-21

Start date

2010-03-31

Completion date

2010-07-31

Last updated

2011-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchitis, Chronic Bronchitis, Community-acquired Pneumonia, Tracheitis, Tracheobronchitis

Keywords

treatment with Klacid®SR, tracheitis, tracheobronchitis, bronchitis, chronic bronchitis, community-acquired pneumonia

Brief summary

The aim of this post-marketing observational study (PMOS) is to describe the relief of symptoms, tolerability and compliance of treatment with Klacid®SR in a dose 1000 mg once daily in patients with lower respiratory tract infection or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).

Detailed description

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men, women at least 18 years old * with acute tracheitis, * acute tracheobronchitis, * acute bronchitis, * mild community-acquired pneumonia or * acute exacerbation of chronic bronchitis

Exclusion criteria

* Patients with known hypersensitivity to macrolide antibiotics * Patients with documented renal impairment (creatinine clearance under 30 ml/min). * Patients with documented liver parenchyma impairment (AST, ALT and GMT \> 3x higher level in comparison with the norm) * Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine * Pregnancy * Breast feeding

Design outcomes

Primary

Measure	Time frame	Description
Compliance (Was the Dosage Followed - Yes, no)	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	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.

Secondary

Measure	Time frame	Description
Body Temperature	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.
Cough and Its Character	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.
Dyspnoea	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.
Auscultation	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.

Countries

Slovakia

Participant flow

Participants by arm

Arm	Count
Acute Respiratory Infections Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.	3,181
Total	3,181

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	12
Overall Study	Non-compliance	15

Baseline characteristics

Characteristic	Acute Respiratory Infections
Age, Customized 20 to 29 years	411 participants
Age, Customized 30 to 39 years	873 participants
Age, Customized 40 to 49 years	787 participants
Age, Customized 50 to 59 years	538 participants
Age, Customized 60 to 69 years	331 participants
Age, Customized 70 to 79 years	130 participants
Age, Customized 80 years or older	50 participants
Age, Customized Age not reported	11 participants
Age, Customized Less than 20 years	50 participants
Diagnosis Acute bronchitis	921 Participants
Diagnosis Acute exacerbation of chronic bronchitis	281 Participants
Diagnosis Acute tracheitis	870 Participants
Diagnosis Acute tracheobronchitis	926 Participants
Diagnosis Mild community-acquired bronchopneumonia	183 Participants
Region of Enrollment Slovakia	3181 participants
Sex: Female, Male Female	NA Participants
Sex: Female, Male Male	NA Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	7 / 3,181
serious Total, serious adverse events	0 / 3,181

Outcome results

Primary

Compliance (Was the Dosage Followed - Yes, no)

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.

Time frame: Day 10 - 16