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

Community-acquired Pneumonia Clinical Trial

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 Bronchopneumonia in Common Clinical Practice in the Slovak Republic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108185
• Other study ID #: P12-060
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: September 9, 2011
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: September 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovak Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3181
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Community-acquired Pneumonia
• Pneumonia
• Respiratory Tract Infections
• Tracheitis
• Tracheobronchitis

Locations

Country	Name	City	State
Slovakia	Site Reference ID/Investigator# 37753	Banska Bystrica
Slovakia	Site Reference ID/Investigator# 37758	Banska Bystrica
Slovakia	Site Reference ID/Investigator# 37806	Bardejov
Slovakia	Site Reference ID/Investigator# 38052	Bojnice
Slovakia	Site Reference ID/Investigator# 25682	Bratislava
Slovakia	Site Reference ID/Investigator# 37677	Bratislava
Slovakia	Site Reference ID/Investigator# 37678	Bratislava
Slovakia	Site Reference ID/Investigator# 37679	Bratislava
Slovakia	Site Reference ID/Investigator# 37680	Bratislava
Slovakia	Site Reference ID/Investigator# 37681	Bratislava
Slovakia	Site Reference ID/Investigator# 37729	Bratislava
Slovakia	Site Reference ID/Investigator# 37732	Bratislava
Slovakia	Site Reference ID/Investigator# 37823	Bratislava
Slovakia	Site Reference ID/Investigator# 37824	Bratislava
Slovakia	Site Reference ID/Investigator# 37825	Bratislava
Slovakia	Site Reference ID/Investigator# 37826	Bratislava
Slovakia	Site Reference ID/Investigator# 37827	Bratislava
Slovakia	Site Reference ID/Investigator# 37828	Bratislava
Slovakia	Site Reference ID/Investigator# 37829	Bratislava
Slovakia	Site Reference ID/Investigator# 37830	Bratislava
Slovakia	Site Reference ID/Investigator# 37831	Bratislava
Slovakia	Site Reference ID/Investigator# 37832	Bratislava
Slovakia	Site Reference ID/Investigator# 37833	Bratislava
Slovakia	Site Reference ID/Investigator# 37834	Bratislava
Slovakia	Site Reference ID/Investigator# 37835	Bratislava
Slovakia	Site Reference ID/Investigator# 37836	Bratislava
Slovakia	Site Reference ID/Investigator# 37837	Bratislava
Slovakia	Site Reference ID/Investigator# 37838	Bratislava
Slovakia	Site Reference ID/Investigator# 37839	Bratislava
Slovakia	Site Reference ID/Investigator# 37840	Bratislava
Slovakia	Site Reference ID/Investigator# 37861	Bratislava
Slovakia	Site Reference ID/Investigator# 37864	Bratislava
Slovakia	Site Reference ID/Investigator# 37866	Bratislava
Slovakia	Site Reference ID/Investigator# 37754	Brezno
Slovakia	Site Reference ID/Investigator# 37755	Brezno
Slovakia	Site Reference ID/Investigator# 37756	Brezno
Slovakia	Site Reference ID/Investigator# 37863	Dojc
Slovakia	Site Reference ID/Investigator# 38048	Dolne Vestenice
Slovakia	Site Reference ID/Investigator# 37694	Dolny Kubin
Slovakia	Site Reference ID/Investigator# 38029	Drienov
Slovakia	Site Reference ID/Investigator# 38056	Dudince
Slovakia	Site Reference ID/Investigator# 37688	Galanta
Slovakia	Site Reference ID/Investigator# 37703	Galanta
Slovakia	Site Reference ID/Investigator# 37808	Giraltovce
Slovakia	Site Reference ID/Investigator# 37708	Horka nad Vahom
Slovakia	Site Reference ID/Investigator# 38054	Hronske Klacany
Slovakia	Site Reference ID/Investigator# 37745	Humenne
Slovakia	Site Reference ID/Investigator# 37752	Humenne
Slovakia	Site Reference ID/Investigator# 37814	Humenne
Slovakia	Site Reference ID/Investigator# 37815	Humenne
Slovakia	Site Reference ID/Investigator# 37687	Jelka
Slovakia	Site Reference ID/Investigator# 37737	Kosice
Slovakia	Site Reference ID/Investigator# 37740	Kosice
Slovakia	Site Reference ID/Investigator# 37741	Kosice
Slovakia	Site Reference ID/Investigator# 37742	Kosice
Slovakia	Site Reference ID/Investigator# 37744	Kosice
Slovakia	Site Reference ID/Investigator# 37767	Kosice
Slovakia	Site Reference ID/Investigator# 37788	Kosice
Slovakia	Site Reference ID/Investigator# 38030	Kosice
Slovakia	Site Reference ID/Investigator# 38035	Kosice
Slovakia	Site Reference ID/Investigator# 38040	Kosice
Slovakia	Site Reference ID/Investigator# 38043	Kosice
Slovakia	Site Reference ID/Investigator# 37810	Levoca
Slovakia	Site Reference ID/Investigator# 37811	Levoca
Slovakia	Site Reference ID/Investigator# 37686	Likavka
Slovakia	Site Reference ID/Investigator# 37690	Lubochna
Slovakia	Site Reference ID/Investigator# 37790	Lucenec
Slovakia	Site Reference ID/Investigator# 37791	Lucenec
Slovakia	Site Reference ID/Investigator# 37792	Lucenec
Slovakia	Site Reference ID/Investigator# 37793	Lucenec
Slovakia	Site Reference ID/Investigator# 37795	Lucenec
Slovakia	Site Reference ID/Investigator# 37797	Lucenec
Slovakia	Site Reference ID/Investigator# 37798	Lucenec
Slovakia	Site Reference ID/Investigator# 37859	Malacky
Slovakia	Site Reference ID/Investigator# 37865	Malacky
Slovakia	Site Reference ID/Investigator# 37696	Martin
Slovakia	Site Reference ID/Investigator# 37702	Martin
Slovakia	Site Reference ID/Investigator# 37706	Martin
Slovakia	Site Reference ID/Investigator# 37743	Michalovce
Slovakia	Site Reference ID/Investigator# 37766	Michalovce
Slovakia	Site Reference ID/Investigator# 38028	Michalovce
Slovakia	Site Reference ID/Investigator# 37862	Modra
Slovakia	Site Reference ID/Investigator# 38042	Moldava nad Bodvou
Slovakia	Site Reference ID/Investigator# 37697	Namestovo
Slovakia	Site Reference ID/Investigator# 38036	Nitra
Slovakia	Site Reference ID/Investigator# 38038	Nitra
Slovakia	Site Reference ID/Investigator# 38039	Nitra
Slovakia	Site Reference ID/Investigator# 38041	Nitra
Slovakia	Site Reference ID/Investigator# 38050	Nitra
Slovakia	Site Reference ID/Investigator# 38053	Nitra
Slovakia	Site Reference ID/Investigator# 37692	Nitrianske Pravno
Slovakia	Site Reference ID/Investigator# 38047	Nitrianske Rudno
Slovakia	Site Reference ID/Investigator# 38045	Novaky
Slovakia	Site Reference ID/Investigator# 38049	Oslany
Slovakia	Site Reference ID/Investigator# 38051	Partizanske
Slovakia	Site Reference ID/Investigator# 37731	Piestany
Slovakia	Site Reference ID/Investigator# 37858	Piestany
Slovakia	Site Reference ID/Investigator# 37812	Podhradie
Slovakia	Site Reference ID/Investigator# 37757	Pohorelska Masa
Slovakia	Site Reference ID/Investigator# 37804	Presov
Slovakia	Site Reference ID/Investigator# 37809	Presov
Slovakia	Site Reference ID/Investigator# 37817	Presov
Slovakia	Site Reference ID/Investigator# 37789	Revuca
Slovakia	Site Reference ID/Investigator# 37799	Revuca
Slovakia	Site Reference ID/Investigator# 37762	Rimavska Sobota
Slovakia	Site Reference ID/Investigator# 37763	Rimavska Sobota
Slovakia	Site Reference ID/Investigator# 37764	Rimavska Sobota
Slovakia	Site Reference ID/Investigator# 37765	Rimavska Sobota
Slovakia	Site Reference ID/Investigator# 37800	Roznava
Slovakia	Site Reference ID/Investigator# 37801	Roznava
Slovakia	Site Reference ID/Investigator# 37693	Ruzomberok
Slovakia	Site Reference ID/Investigator# 37698	Ruzomberok
Slovakia	Site Reference ID/Investigator# 37685	Samorin
Slovakia	Site Reference ID/Investigator# 37735	Selice
Slovakia	Site Reference ID/Investigator# 37733	Senec
Slovakia	Site Reference ID/Investigator# 37730	Senica
Slovakia	Site Reference ID/Investigator# 38055	Slatina nad Bebravou
Slovakia	Site Reference ID/Investigator# 37805	Slovinky
Slovakia	Site Reference ID/Investigator# 38033	Snina
Slovakia	Site Reference ID/Investigator# 38034	Snina
Slovakia	Site Reference ID/Investigator# 38037	Snina
Slovakia	Site Reference ID/Investigator# 37746	Spisska Nova Ves
Slovakia	Site Reference ID/Investigator# 37747	Spisska Nova Ves
Slovakia	Site Reference ID/Investigator# 37748	Spisska Nova Ves
Slovakia	Site Reference ID/Investigator# 37750	Spisska Nova Ves
Slovakia	Site Reference ID/Investigator# 37751	Spisska Nova Ves
Slovakia	Site Reference ID/Investigator# 37813	Spisska Nova Ves
Slovakia	Site Reference ID/Investigator# 37736	Streda nad Bodrogom
Slovakia	Site Reference ID/Investigator# 38031	Streda nad Bodrogom
Slovakia	Site Reference ID/Investigator# 37860	Stupava
Slovakia	Site Reference ID/Investigator# 37816	Svidnik
Slovakia	Site Reference ID/Investigator# 38046	Topolcany
Slovakia	Site Reference ID/Investigator# 37699	Trencin
Slovakia	Site Reference ID/Investigator# 37734	Trencin
Slovakia	Site Reference ID/Investigator# 37682	Trhova Hradska
Slovakia	Site Reference ID/Investigator# 37683	Trhova Hradska
Slovakia	Site Reference ID/Investigator# 37691	Trnava
Slovakia	Site Reference ID/Investigator# 37705	Trnava
Slovakia	Site Reference ID/Investigator# 37870	Trnava
Slovakia	Site Reference ID/Investigator# 37701	Trnovec nad Vahom
Slovakia	Site Reference ID/Investigator# 37695	Turany
Slovakia	Site Reference ID/Investigator# 38032	Velke Kapusany
Slovakia	Site Reference ID/Investigator# 37868	Velke Kostolany
Slovakia	Site Reference ID/Investigator# 37760	Velky Krtis
Slovakia	Site Reference ID/Investigator# 37761	Velky Krtis
Slovakia	Site Reference ID/Investigator# 37807	Vranov nad Toplou
Slovakia	Site Reference ID/Investigator# 37867	Vrbove
Slovakia	Site Reference ID/Investigator# 37684	Vrutky
Slovakia	Site Reference ID/Investigator# 38044	Zabokreky nad Nitrou
Slovakia	Site Reference ID/Investigator# 37689	Zilina
Slovakia	Site Reference ID/Investigator# 37700	Zilina
Slovakia	Site Reference ID/Investigator# 37704	Zilina
Slovakia	Site Reference ID/Investigator# 37707	Zilina
Slovakia	Site Reference ID/Investigator# 37869	Zohor
Slovakia	Site Reference ID/Investigator# 37794	Zvolen
Slovakia	Site Reference ID/Investigator# 37796	Zvolen
Slovakia	Site Reference ID/Investigator# 37802	Zvolen
Slovakia	Site Reference ID/Investigator# 37803	Zvolen

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 10 - 16	No
Primary	The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events	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.	Day 0 through Days 10 - 16	No
Secondary	Body Temperature	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.	Day 0	No
Secondary	Body Temperature	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.	Day 10 - 16	No
Secondary	Cough and Its Character	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.	Day 0	No
Secondary	Cough and Its Character	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.	Day 10 - 16	No
Secondary	Dyspnoea	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.	Day 0	No
Secondary	Dyspnoea	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.	Day 10 - 16	No
Secondary	Auscultation	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.	Day 0	No
Secondary	Auscultation	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.	Day 10 - 16	No