Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR

Chronic Bronchitis Clinical Trial

Official title:

Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR in Patients With Upper Respiratory Infection, Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in the Czech Republic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130883
• Other study ID #: P12-109
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: September 8, 2011
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: September 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial Summary

This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, 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 acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, 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. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.

Description:

Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3130
• 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.

• Patients treated with Klacid®SR between 6 weeks and 24 months prior to start of the PMOS.

• Patients:

• with acute tracheitis,

• acute tracheobronchitis,

• acute bronchitis,

• mild community-acquired pneumonia or

• acute exacerbation of chronic bronchitis

Exclusion Criteria:

• Patients without previous administration of Klacid®SR and patients who used Klacid®SR less than 6 weeks ago or more than 24 months ago. The information about previous administration of Klacid®SR will be based on physician records or patients anamnesis.

• 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 (CAP)
• Pneumonia
• Tracheitis
• Tracheobronchitis

Locations

Country	Name	City	State
Czech Republic	Site Reference ID/Investigator# 37381	Bilina
Czech Republic	Site Reference ID/Investigator# 37391	Bilina
Czech Republic	Site Reference ID/Investigator# 37282	Blansko
Czech Republic	Site Reference ID/Investigator# 37324	Blansko
Czech Republic	Site Reference ID/Investigator# 37424	Boskovice
Czech Republic	Site Reference ID/Investigator# 37329	Brandys nad Labem
Czech Republic	Site Reference ID/Investigator# 37443	Breclav
Czech Republic	Site Reference ID/Investigator# 37268	Brno
Czech Republic	Site Reference ID/Investigator# 37299	Brno
Czech Republic	Site Reference ID/Investigator# 37327	Brno
Czech Republic	Site Reference ID/Investigator# 37331	Brno
Czech Republic	Site Reference ID/Investigator# 37380	Brno
Czech Republic	Site Reference ID/Investigator# 37396	Brno
Czech Republic	Site Reference ID/Investigator# 37403	Brno
Czech Republic	Site Reference ID/Investigator# 37411	Brno
Czech Republic	Site Reference ID/Investigator# 37429	Bucovice
Czech Republic	Site Reference ID/Investigator# 37444	Bucovice
Czech Republic	Site Reference ID/Investigator# 37298	Budweis
Czech Republic	Site Reference ID/Investigator# 37433	Bustehrad
Czech Republic	Site Reference ID/Investigator# 37374	Caslav
Czech Republic	Site Reference ID/Investigator# 37267	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 37269	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 37302	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 37392	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 37408	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 37362	Cheb
Czech Republic	Site Reference ID/Investigator# 47286	Cheb
Czech Republic	Site Reference ID/Investigator# 37413	Chrudim
Czech Republic	Site Reference ID/Investigator# 37372	Decin
Czech Republic	Site Reference ID/Investigator# 37394	Decin
Czech Republic	Site Reference ID/Investigator# 26623	Hardec Kralove
Czech Republic	Site Reference ID/Investigator# 37270	Hardec Kralove
Czech Republic	Site Reference ID/Investigator# 37371	Hardec Kralove
Czech Republic	Site Reference ID/Investigator# 43225	Hardec Kralove
Czech Republic	Site Reference ID/Investigator# 37263	Holesov
Czech Republic	Site Reference ID/Investigator# 43230	Holesov
Czech Republic	Site Reference ID/Investigator# 37274	Hradek
Czech Republic	Site Reference ID/Investigator# 37367	Hranice
Czech Republic	Site Reference ID/Investigator# 37364	Hrebec
Czech Republic	Site Reference ID/Investigator# 37404	Jablonec nad Nisou
Czech Republic	Site Reference ID/Investigator# 47283	Jablonec nad Nisou
Czech Republic	Site Reference ID/Investigator# 43229	Jaromer
Czech Republic	Site Reference ID/Investigator# 37376	Jindrichuv Hradec
Czech Republic	Site Reference ID/Investigator# 37290	Kaplice
Czech Republic	Site Reference ID/Investigator# 37363	Karlovy Vary
Czech Republic	Site Reference ID/Investigator# 37369	Karlovy Vary
Czech Republic	Site Reference ID/Investigator# 37445	Karlovy Vary
Czech Republic	Site Reference ID/Investigator# 37283	Kladno
Czech Republic	Site Reference ID/Investigator# 37382	Kolin
Czech Republic	Site Reference ID/Investigator# 37368	Konice
Czech Republic	Site Reference ID/Investigator# 37415	Konice
Czech Republic	Site Reference ID/Investigator# 37272	Kralovice
Czech Republic	Site Reference ID/Investigator# 42162	Kunovice
Czech Republic	Site Reference ID/Investigator# 43224	Kyjov
Czech Republic	Site Reference ID/Investigator# 37323	Letohrad
Czech Republic	Site Reference ID/Investigator# 37389	Liberec
Czech Republic	Site Reference ID/Investigator# 37416	Litomysl
Czech Republic	Site Reference ID/Investigator# 37384	Litvinov
Czech Republic	Site Reference ID/Investigator# 37428	Marianske Lazne
Czech Republic	Site Reference ID/Investigator# 37289	Melnik
Czech Republic	Site Reference ID/Investigator# 37293	Mestec Kralove
Czech Republic	Site Reference ID/Investigator# 43228	Mohelnice
Czech Republic	Site Reference ID/Investigator# 43233	Mohelnice
Czech Republic	Site Reference ID/Investigator# 43227	Moravska Trebova
Czech Republic	Site Reference ID/Investigator# 47290	Most
Czech Republic	Site Reference ID/Investigator# 37297	Neratovice
Czech Republic	Site Reference ID/Investigator# 37397	Novy Bor
Czech Republic	Site Reference ID/Investigator# 37303	Novy Jicin
Czech Republic	Site Reference ID/Investigator# 37400	Novy Jicin
Czech Republic	Site Reference ID/Investigator# 37399	Obristvi
Czech Republic	Site Reference ID/Investigator# 37279	Olomouc
Czech Republic	Site Reference ID/Investigator# 37280	Olomouc
Czech Republic	Site Reference ID/Investigator# 37395	Pardubice
Czech Republic	Site Reference ID/Investigator# 47284	Plana
Czech Republic	Site Reference ID/Investigator# 37271	Plzen
Czech Republic	Site Reference ID/Investigator# 37273	Plzen
Czech Republic	Site Reference ID/Investigator# 37423	Plzen
Czech Republic	Site Reference ID/Investigator# 37431	Plzen
Czech Republic	Site Reference ID/Investigator# 37325	Podebrady
Czech Republic	Site Reference ID/Investigator# 47282	Podebrady
Czech Republic	Site Reference ID/Investigator# 37262	Prague
Czech Republic	Site Reference ID/Investigator# 37275	Prague
Czech Republic	Site Reference ID/Investigator# 37288	Prague
Czech Republic	Site Reference ID/Investigator# 37291	Prague
Czech Republic	Site Reference ID/Investigator# 37300	Prague
Czech Republic	Site Reference ID/Investigator# 37301	Prague
Czech Republic	Site Reference ID/Investigator# 37326	Prague
Czech Republic	Site Reference ID/Investigator# 37330	Prague
Czech Republic	Site Reference ID/Investigator# 37332	Prague
Czech Republic	Site Reference ID/Investigator# 37328	Prague 1
Czech Republic	Site Reference ID/Investigator# 37375	Prague 10
Czech Republic	Site Reference ID/Investigator# 37294	Prague 14
Czech Republic	Site Reference ID/Investigator# 37398	Prague 2
Czech Republic	Site Reference ID/Investigator# 37410	Prague 3
Czech Republic	Site Reference ID/Investigator# 37387	Prague 4
Czech Republic	Site Reference ID/Investigator# 37390	Prague 4
Czech Republic	Site Reference ID/Investigator# 43232	Prague 4
Czech Republic	Site Reference ID/Investigator# 43236	Prague 4
Czech Republic	Site Reference ID/Investigator# 43365	Prague 4
Czech Republic	Site Reference ID/Investigator# 37295	Prague 5
Czech Republic	Site Reference ID/Investigator# 37427	Prague 5
Czech Republic	Site Reference ID/Investigator# 37419	Prague 6
Czech Republic	Site Reference ID/Investigator# 37438	Prague 6
Czech Republic	Site Reference ID/Investigator# 37414	Prague 9
Czech Republic	Site Reference ID/Investigator# 47289	Prague 9
Czech Republic	Site Reference ID/Investigator# 37378	Pribor
Czech Republic	Site Reference ID/Investigator# 37412	Pribor
Czech Republic	Site Reference ID/Investigator# 37425	Pribram
Czech Republic	Site Reference ID/Investigator# 37432	Pribram
Czech Republic	Site Reference ID/Investigator# 37430	Prostejov
Czech Republic	Site Reference ID/Investigator# 37437	Prostejov
Czech Republic	Site Reference ID/Investigator# 37442	Rakovnik
Czech Republic	Site Reference ID/Investigator# 37393	Raspenava
Czech Republic	Site Reference ID/Investigator# 37421	Roznov pod Radhostem
Czech Republic	Site Reference ID/Investigator# 37287	Sadova
Czech Republic	Site Reference ID/Investigator# 37406	Slapanice
Czech Republic	Site Reference ID/Investigator# 37383	Steti
Czech Republic	Site Reference ID/Investigator# 37278	Sumperk
Czech Republic	Site Reference ID/Investigator# 43223	Sumperk
Czech Republic	Site Reference ID/Investigator# 43234	Sumperk
Czech Republic	Site Reference ID/Investigator# 37285	Tachov
Czech Republic	Site Reference ID/Investigator# 37386	Teplice
Czech Republic	Site Reference ID/Investigator# 37264	Trebic
Czech Republic	Site Reference ID/Investigator# 37277	Trebic
Czech Republic	Site Reference ID/Investigator# 43231	Trebon
Czech Republic	Site Reference ID/Investigator# 37405	Trinec
Czech Republic	Site Reference ID/Investigator# 43366	Tyn
Czech Republic	Site Reference ID/Investigator# 37265	Tyn nad Vltavou
Czech Republic	Site Reference ID/Investigator# 37434	Uherske Hradiste
Czech Republic	Site Reference ID/Investigator# 37365	Uhersky Brod
Czech Republic	Site Reference ID/Investigator# 37284	Velke Pavlovice
Czech Republic	Site Reference ID/Investigator# 37385	Vlasim
Czech Republic	Site Reference ID/Investigator# 37322	Zamberk
Czech Republic	Site Reference ID/Investigator# 37366	Zdar nad Sazavou
Czech Republic	Site Reference ID/Investigator# 43235	Zlin

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disappearance or Significant Alleviation of Symptoms	Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response.	Day 8 - 16	No
Primary	Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)	Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).	Day 0, Day 8 - 16	No
Secondary	Body Temperature	Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).	Day 0, Day 8-16	No
Secondary	Bacteriological Investigation (if Available)	The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.	Day 0	No
Secondary	Cough and Its Character	Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)	Day 0, Day 8-16	No
Secondary	Dyspnea and Its Type	Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).	Day 0, Day 8-16	No
Secondary	Auscultation	Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).	Day 0, Day 8-16	No
Secondary	Chest X-ray in Case of Community-Acquired Pneumonia (CAP)	Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.	Day 0	No
Secondary	Study Drug Given as the First, Second or Third Antimicrobial Treatment	Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.	Day 0	No
Secondary	Compliance	Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.	Day 8 - 16	No
Secondary	Termination of Treatment Due to Noncompliance	Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.	Day 8 - 16	No