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

Respiratory Tract Infections Clinical Trial

— KLARAINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095978
• Other study ID #: P11-979
• Status: Completed
• Phase: N/A
• First received: February 28, 2010
• Last updated: June 29, 2011
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: State Pharmacological Center - Ministry of HealthUkraine: Ministry of Health
• Study type: Observational

Clinical Trial Summary

To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid® sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis, acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic bronchitis or mild community-acquired pneumonia.

This postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format.

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 with local guidelines.

Description:

The postmarketing observational study is observational in nature. Its follow-up is not interventional and is left to the judgment of each physician during the observational period, which defines the survey for each patient. Follow-up of patients should enable two patient visits during this period.

The screening/inclusion visit (Visit 1) will be performed when the decision for Klacid SR therapy in a daily dose of 1000 mg is made. The second visit of the patient will occur 10 - 16 days from the screening/inclusion Visit (upon physician's decision). The physician can change the numbers and time of the visits. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2822
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men, women 18 years with

1. Acute tracheitis.

2. Acute tracheobronchitis.

3. Acute bronchitis.

4. Mild community-acquired pneumonia.

5. Acute exacerbation of chronic bronchitis.

• To whom decision to initiate Klacid SR therapy in a dose of 1000 mg has been made by physician.

Exclusion Criteria:

• Known hypersensitivity to macrolide antibiotics

• Documented renal impairment (creatinine clearance under 30 ml/min)

• Concomitant therapy with the following drugs: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine

• Pregnancy

• Breast feeding

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Pneumonia
• Respiratory Tract Infections
• Tracheitis

Intervention

Drug:
• Clarithromycin (Klacid SR)
Klacid SR in a dose of 1000 mg once daily

Locations

Country	Name	City	State
Ukraine	Site Reference ID/Investigator# 29842	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 29848	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30028	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30046	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30047	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30049	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30059	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30074	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30080	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30099	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30535	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30572	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30574	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30575	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30576	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30577	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30578	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30579	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30580	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30581	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30582	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30583	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30589	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30590	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30622	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30623	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 30050	Donetsk
Ukraine	Site Reference ID/Investigator# 30051	Donetsk
Ukraine	Site Reference ID/Investigator# 30054	Donetsk
Ukraine	Site Reference ID/Investigator# 30057	Donetsk
Ukraine	Site Reference ID/Investigator# 30060	Donetsk
Ukraine	Site Reference ID/Investigator# 30066	Donetsk
Ukraine	Site Reference ID/Investigator# 30071	Donetsk
Ukraine	Site Reference ID/Investigator# 30073	Donetsk
Ukraine	Site Reference ID/Investigator# 30573	Donetsk
Ukraine	Site Reference ID/Investigator# 30584	Donetsk
Ukraine	Site Reference ID/Investigator# 30585	Donetsk
Ukraine	Site Reference ID/Investigator# 30586	Donetsk
Ukraine	Site Reference ID/Investigator# 30587	Donetsk
Ukraine	Site Reference ID/Investigator# 30588	Donetsk
Ukraine	Site Reference ID/Investigator# 30600	Donetsk
Ukraine	Site Reference ID/Investigator# 30601	Donetsk
Ukraine	Site Reference ID/Investigator# 29840	Kharkov
Ukraine	Site Reference ID/Investigator# 30052	Kharkov
Ukraine	Site Reference ID/Investigator# 30056	Kharkov
Ukraine	Site Reference ID/Investigator# 30058	Kharkov
Ukraine	Site Reference ID/Investigator# 30065	Kharkov
Ukraine	Site Reference ID/Investigator# 30067	Kharkov
Ukraine	Site Reference ID/Investigator# 30075	Kharkov
Ukraine	Site Reference ID/Investigator# 30076	Kharkov
Ukraine	Site Reference ID/Investigator# 30078	Kharkov
Ukraine	Site Reference ID/Investigator# 30079	Kharkov
Ukraine	Site Reference ID/Investigator# 30096	Kharkov
Ukraine	Site Reference ID/Investigator# 30102	Kharkov
Ukraine	Site Reference ID/Investigator# 30616	Kharkov
Ukraine	Site Reference ID/Investigator# 30617	Kharkov
Ukraine	Site Reference ID/Investigator# 30624	Kharkov
Ukraine	Site Reference ID/Investigator# 30625	Kharkov
Ukraine	Site Reference ID/Investigator# 30626	Kharkov
Ukraine	Site Reference ID/Investigator# 30627	Kharkov
Ukraine	Site Reference ID/Investigator# 30628	Kharkov
Ukraine	Site Reference ID/Investigator# 30632	Kharkov
Ukraine	Site Reference ID/Investigator# 30633	Kharkov
Ukraine	Site Reference ID/Investigator# 40761	Kharkov
Ukraine	Site Reference ID/Investigator# 22142	Kiev
Ukraine	Site Reference ID/Investigator# 29839	Kiev
Ukraine	Site Reference ID/Investigator# 30027	Kiev
Ukraine	Site Reference ID/Investigator# 30061	Kiev
Ukraine	Site Reference ID/Investigator# 30069	Kiev
Ukraine	Site Reference ID/Investigator# 30097	Kiev
Ukraine	Site Reference ID/Investigator# 30098	Kiev
Ukraine	Site Reference ID/Investigator# 30100	Kiev
Ukraine	Site Reference ID/Investigator# 30101	Kiev
Ukraine	Site Reference ID/Investigator# 30533	Kiev
Ukraine	Site Reference ID/Investigator# 30534	Kiev
Ukraine	Site Reference ID/Investigator# 30537	Kiev
Ukraine	Site Reference ID/Investigator# 30538	Kiev
Ukraine	Site Reference ID/Investigator# 30539	Kiev
Ukraine	Site Reference ID/Investigator# 30540	Kiev
Ukraine	Site Reference ID/Investigator# 30553	Kiev
Ukraine	Site Reference ID/Investigator# 30554	Kiev
Ukraine	Site Reference ID/Investigator# 30555	Kiev
Ukraine	Site Reference ID/Investigator# 30556	Kiev
Ukraine	Site Reference ID/Investigator# 30557	Kiev
Ukraine	Site Reference ID/Investigator# 30558	Kiev
Ukraine	Site Reference ID/Investigator# 30591	Kiev
Ukraine	Site Reference ID/Investigator# 30592	Kiev
Ukraine	Site Reference ID/Investigator# 30593	Kiev
Ukraine	Site Reference ID/Investigator# 30614	Kiev
Ukraine	Site Reference ID/Investigator# 30615	Kiev
Ukraine	Site Reference ID/Investigator# 30531	Kremenchug
Ukraine	Site Reference ID/Investigator# 30532	Kremenchug
Ukraine	Site Reference ID/Investigator# 40759	Kyiv
Ukraine	Site Reference ID/Investigator# 40760	Kyiv
Ukraine	Site Reference ID/Investigator# 30604	Lugansk
Ukraine	Site Reference ID/Investigator# 30605	Lugansk
Ukraine	Site Reference ID/Investigator# 30606	Lugansk
Ukraine	Site Reference ID/Investigator# 30559	Lvov
Ukraine	Site Reference ID/Investigator# 30561	Lvov
Ukraine	Site Reference ID/Investigator# 30562	Lvov
Ukraine	Site Reference ID/Investigator# 30563	Lvov
Ukraine	Site Reference ID/Investigator# 30564	Lvov
Ukraine	Site Reference ID/Investigator# 29948	Odesa
Ukraine	Site Reference ID/Investigator# 30055	Odesa
Ukraine	Site Reference ID/Investigator# 30062	Odesa
Ukraine	Site Reference ID/Investigator# 30594	Odesa
Ukraine	Site Reference ID/Investigator# 30595	Odesa
Ukraine	Site Reference ID/Investigator# 29838	Poltava
Ukraine	Site Reference ID/Investigator# 30044	Poltava
Ukraine	Site Reference ID/Investigator# 30045	Poltava
Ukraine	Site Reference ID/Investigator# 30063	Poltava
Ukraine	Site Reference ID/Investigator# 30126	Poltava
Ukraine	Site Reference ID/Investigator# 30618	Poltava
Ukraine	Site Reference ID/Investigator# 30619	Poltava
Ukraine	Site Reference ID/Investigator# 30620	Poltava
Ukraine	Site Reference ID/Investigator# 30621	Poltava
Ukraine	Site Reference ID/Investigator# 30072	Simferopol'
Ukraine	Site Reference ID/Investigator# 30629	Vynnytsya
Ukraine	Site Reference ID/Investigator# 30631	Vynnytsya
Ukraine	Site Reference ID/Investigator# 30190	Yevpatoriya
Ukraine	Site Reference ID/Investigator# 30068	Zaporizhya
Ukraine	Site Reference ID/Investigator# 30565	Zaporizhya
Ukraine	Site Reference ID/Investigator# 30566	Zaporizhya
Ukraine	Site Reference ID/Investigator# 30567	Zaporizhya
Ukraine	Site Reference ID/Investigator# 30568	Zaporizhya
Ukraine	Site Reference ID/Investigator# 30570	Zaporizhya

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Temperature	Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.	Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)	No
Primary	Cough and Its Character	Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.	Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)	No
Primary	Dyspnoea	Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.	Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)	No
Primary	Auscultation Findings	Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.	Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)	No
Primary	Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia	Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.	Visit 1 (Initial visit)	No
Primary	Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)	Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.	Visit 1 (Initial visit)	No
Primary	Therapeutic Response	Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.	Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)	No
Secondary	Adverse Effects	The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.	Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)	Yes
Secondary	Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)	Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.	Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)	No
Secondary	Termination of Treatment	The number of participants who discontinued treatment is summarized.	Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)	No