Clarithromycin (Klacid SR)
DrugKlacid SR in a dose of 1000 mg once daily
Other names: Biaxin, Abbotic, Biclar, Klacid, Klaricid, Zeclar, Clarithromycin, Klacid SR
NCT Number: NCT01095978
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Site Reference ID/Investigator# 29842, Dnipro, Ukraine
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Klacid SR in a dose of 1000 mg once daily
Other names: Biaxin, Abbotic, Biclar, Klacid, Klaricid, Zeclar, Clarithromycin, Klacid SR
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
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.
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
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.
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
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.
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
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.
Time frame: Visit 1 (Initial visit)
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.
Time frame: Visit 1 (Initial visit)
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.
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
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.
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
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.
Time frame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)
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.
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The number of participants who discontinued treatment is summarized.
Abbott
Industry
Acronym: KLARAINE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01033799
Bronchial Diseases, Bronchitis
München, Germany
View Trial DetailsNCT06495021
Bronchial Diseases, Bronchitis
Bloomsburg, Pennsylvania, United States
View Trial DetailsNCT05622942
Infections, Lung Diseases
Puer, Yunnan, China
View Trial DetailsNCT05321433
COVID-19, Coronaviridae Infections
Solna, Stockholm County, Sweden
View Trial Details