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

NCT01095978 | Completed Results

• 1 other identifier: P11-979
• Study Type: observational
• Target: 2,822
• Locations: 1 country
• Sites: 126

Brief 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.

Conditions

Respiratory Tract Infections

Keywords

Klacid SR; Clarithromycin; Respiratory tract infections; Bronchitis; Pneumonia

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (3)

• Adverse Effects

  Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)

• Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)

  Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)

• Termination of Treatment

  Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)

Study Arms (1)

Acute upper respiratory tract diseases, bronchitis, pneumonia

Drug: Clarithromycin (Klacid SR)

Interventions

Clarithromycin (Klacid SR) DRUG

Klacid SR in a dose of 1000 mg once daily

Also known as: Biaxin, Abbotic, Biclar, Klacid, Klaricid, Zeclar, Clarithromycin, Klacid SR

Acute upper respiratory tract diseases, bronchitis, pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consulting rooms of general practitioners, pulmonologists, and allergologists and centers with experience in the treatment of patients with acute upper respiratory tract diseases, acute bronchitis or acute exacerbation of chronic bronchitis or mild community-acquired pneumonia.

You may qualify if:

• Men, women 18 years with
• Acute tracheitis.
• Acute tracheobronchitis.
• Acute bronchitis.
• Mild community-acquired pneumonia.
• Acute exacerbation of chronic bronchitis.
• To whom decision to initiate Klacid SR therapy in a dose of 1000 mg has been made by physician.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (126)

Site Reference ID/Investigator# 29842

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 29848

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30028

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30046

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30047

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30049

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30059

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30074

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30080

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30099

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30535

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30572

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30574

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30575

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30576

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30577

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30578

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30579

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30580

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30581

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30582

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30583

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30589

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30590

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30622

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30623

Dnipro, 49000, Ukraine

Location

Site Reference ID/Investigator# 30050

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30051

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30054

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30057

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30060

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30066

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30071

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30073

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30573

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30584

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30585

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30600

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30601

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 30586

Donetsk, 83112, Ukraine

Location

Site Reference ID/Investigator# 30587

Donetsk, 83112, Ukraine

Location

Site Reference ID/Investigator# 30588

Donetsk, 83112, Ukraine

Location

Site Reference ID/Investigator# 29840

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30052

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30056

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30058

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30065

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30067

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30075

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30076

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30078

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30079

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30096

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30102

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30616

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30617

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30624

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30625

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30626

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30627

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30628

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30632

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30633

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 40761

Kharkiv, 61000, Ukraine

Location

Site Reference ID/Investigator# 30027

Kiev, 01000, Ukraine

Location

Site Reference ID/Investigator# 30097

Kiev, 01004, Ukraine

Location

Site Reference ID/Investigator# 30098

Kiev, 01004, Ukraine

Location

Site Reference ID/Investigator# 30100

Kiev, 01004, Ukraine

Location

Site Reference ID/Investigator# 30614

Kiev, 01004, Ukraine

Location

Site Reference ID/Investigator# 30615

Kiev, 01004, Ukraine

Location

Site Reference ID/Investigator# 30101

Kiev, 01030, Ukraine

Location

Site Reference ID/Investigator# 22142

Kiev, 01033, Ukraine

Location

Site Reference ID/Investigator# 30553

Kiev, 01033, Ukraine

Location

Site Reference ID/Investigator# 30554

Kiev, 01033, Ukraine

Location

Site Reference ID/Investigator# 30555

Kiev, 01033, Ukraine

Location

Site Reference ID/Investigator# 30556

Kiev, 01033, Ukraine

Location

Site Reference ID/Investigator# 30557

Kiev, 01033, Ukraine

Location

Site Reference ID/Investigator# 30558

Kiev, 01033, Ukraine

Location

Site Reference ID/Investigator# 30061

Kiev, 02094, Ukraine

Location

Site Reference ID/Investigator# 30533

Kiev, 03026, Ukraine

Location

Site Reference ID/Investigator# 30534

Kiev, 03026, Ukraine

Location

Site Reference ID/Investigator# 30591

Kiev, 03110, Ukraine

Location

Site Reference ID/Investigator# 30592

Kiev, 03110, Ukraine

Location

Site Reference ID/Investigator# 30593

Kiev, 03110, Ukraine

Location

Site Reference ID/Investigator# 30069

Kiev, 03115, Ukraine

Location

Site Reference ID/Investigator# 30537

Kiev, 04053, Ukraine

Location

Site Reference ID/Investigator# 30538

Kiev, 04053, Ukraine

Location

Site Reference ID/Investigator# 30539

Kiev, 04053, Ukraine

Location

Site Reference ID/Investigator# 30540

Kiev, 04053, Ukraine

Location

Site Reference ID/Investigator# 29839

Kiev, 04074, Ukraine

Location

Site Reference ID/Investigator# 30531

Kremenchuk, 39600, Ukraine

Location

Site Reference ID/Investigator# 30532

Kremenchuk, 39600, Ukraine

Location

Site Reference ID/Investigator# 40759

Kyiv, 22666, Ukraine

Location

Site Reference ID/Investigator# 40760

Kyiv, 22666, Ukraine

Location

Site Reference ID/Investigator# 30604

Luhansk, 91000, Ukraine

Location

Site Reference ID/Investigator# 30605

Luhansk, 91000, Ukraine

Location

Site Reference ID/Investigator# 30606

Luhansk, 91000, Ukraine

Location

Site Reference ID/Investigator# 30559

Lviv, 79000, Ukraine

Location

Site Reference ID/Investigator# 30561

Lviv, 79000, Ukraine

Location

Site Reference ID/Investigator# 30562

Lviv, 79000, Ukraine

Location

Site Reference ID/Investigator# 30563

Lviv, 79000, Ukraine

Location

Site Reference ID/Investigator# 30564

Lviv, 79000, Ukraine

Location

Site Reference ID/Investigator# 29948

Odesa, 65000, Ukraine

Location

Site Reference ID/Investigator# 30055

Odesa, 65000, Ukraine

Location

Site Reference ID/Investigator# 30062

Odesa, 65000, Ukraine

Location

Site Reference ID/Investigator# 30594

Odesa, 65000, Ukraine

Location

Site Reference ID/Investigator# 30595

Odesa, 65000, Ukraine

Location

Site Reference ID/Investigator# 29838

Poltava, 36000, Ukraine

Location

Site Reference ID/Investigator# 30044

Poltava, 36000, Ukraine

Location

Site Reference ID/Investigator# 30045

Poltava, 36000, Ukraine

Location

Site Reference ID/Investigator# 30063

Poltava, 36000, Ukraine

Location

Site Reference ID/Investigator# 30126

Poltava, 36000, Ukraine

Location

Site Reference ID/Investigator# 30618

Poltava, 36000, Ukraine

Location

Site Reference ID/Investigator# 30619

Poltava, 36000, Ukraine

Location

Site Reference ID/Investigator# 30620

Poltava, 36000, Ukraine

Location

Site Reference ID/Investigator# 30621

Poltava, Poltava, Ukraine

Location

Site Reference ID/Investigator# 30072

Simferopol, 95000, Ukraine

Location

Site Reference ID/Investigator# 30629

Vynnytsya, 21000, Ukraine

Location

Site Reference ID/Investigator# 30631

Vynnytsya, 21000, Ukraine

Location

Site Reference ID/Investigator# 30190

Yevpatoria, 97400, Ukraine

Location

Site Reference ID/Investigator# 30068

Zaporizhya, 69000, Ukraine

Location

Site Reference ID/Investigator# 30565

Zaporizhya, 69000, Ukraine

Location

Site Reference ID/Investigator# 30566

Zaporizhya, 69000, Ukraine

Location

Site Reference ID/Investigator# 30567

Zaporizhya, 69000, Ukraine

Location

Site Reference ID/Investigator# 30568

Zaporizhya, 69000, Ukraine

Location

Site Reference ID/Investigator# 30570

Zaporizhya, 69000, Ukraine

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Bronchitis; Pneumonia

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Irina Magdik, MD

  Abbott Laboratories S.A., Ukraine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2010
• First Posted: March 30, 2010
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 11, 2011
• Results First Posted: June 15, 2011

Record last verified: 2011-06

Locations

UA (126)