An observational study in Respiratory Tract Infection, sponsored by Abbott. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-12.
Sponsored by Abbott · Observational
The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 335 is above the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.
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Assignment to clarithromycin therapy falls within current clinical practice and was not decided in advance by this protocol. Study participants were selected from patients seen at the primary care clinic, with a preliminary clinical diagnosis of an upper or lower respiratory tract infection who were considered for antibiotic treatment and prescribed clarithromycin.
Patients with respiratory tract infections, including any of the following:
Exclusion Criteria:
Concomitant use of any of the following medications:
Patients with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Drug: clarithromycin modified release 500 mg
clarithromycin modified release 500 mg for 7 days
Also known as: Clarithromycin Modified Release 500 mg (Klacid XL)
Percentage of Participants With a Fast Recovery
Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment. Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom.
Time frame: Day 1 to Day 5
Percentage of Participants With Clinical Success
Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.
Time frame: 10 days
Classification of Overall Response
Based on the participant and physician's assessment, overall symptom response was classified as follows: * Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment. * Slow Responders: participants showing clinical recovery between Day 6 \& Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms). * Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms).
Time frame: 10 days
Percentage of Participants With Treatment Failure
Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms. Participants with treatment failure were further categorized as: * All symptoms improved but not resolved within the study period; * Some symptoms improved and some resolved; * Some symptoms resolved or improved while other symptoms did not improve (unchanged); * Some symptoms resolved or improved while other symptoms became worse.
Time frame: 10 days
Factors Affecting the Speed of Recovery
Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.
Time frame: 10 days
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.
Time frame: 10 days
Fever Status at End of Study
Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.
Time frame: 10 days
Cough Status at End of Study
Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.
Time frame: 10 days
Sputum Status at End of Study
Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.
Time frame: 10 days
Dyspnea Status at End of Study
Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.
Time frame: 10 days
Abnormal Breathing Sounds Status at End of Study
Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.
Time frame: 10 days
Rhinorrhea Status at End of Study
Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.
Time frame: 10 days
Post-nasal Discharge Status at End of Study
Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.
Time frame: 10 days
Percentage of Participants Compliant With Treatment
Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.
Time frame: 10 days
| Milestone | Clarithromycin Modified Release |
|---|---|
| Started | 335 |
| Completed | 335 |
| Not completed | 0 |
Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment. Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom.
| percentage of participants | Clarithromycin Modified Release |
|---|---|
| All symptoms together [N=335] | 12.8 |
| Fever response [N=184] | 54.3 |
| Cough response [N=215] | 27.4 |
| Sputum response [N=212] | 29.7 |
| Dyspnea response [N=62] | 37.1 |
| Abnormal breath sounds response [N=47] | 42.6 |
| Rhinorrhea response [N=113] | 28.3 |
| Nasal congestion response [N=233] | 33.5 |
| Post-nasal discharge response [N=178] | 18.5 |
| Sneezing response [N=87] | 25.3 |
| Sore throat response [N=200] | 38.0 |
| Painful swallowing response [N=162] | 38.9 |
| Itchy watery eye response [N=33] | 6.1 |
| Malaise response [N=68] | 30.9 |
| Myalgia response [N=79] | 34.2 |
Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms. Participants with treatment failure were further categorized as: * All symptoms improved but not resolved within the study period; * Some symptoms improved and some resolved; * Some symptoms resolved or improved while other symptoms did not improve (unchanged); * Some symptoms resolved or improved while other symptoms became worse.
| percentage of participants | Clarithromycin Modified Release |
|---|---|
| Treatment failure total | 13.1 |
| All symptoms improved but not resolved | 0.9 |
| Some symptoms improved and some resolved | 3.9 |
| Some symptoms resolved/improved, others unchanged | 6.9 |
| Some symptoms resolved/improved/others worsened | 1.5 |
Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.
| coefficient | Clarithromycin Modified Release |
|---|---|
| Age | -0.007 |
| Gender | 0.216 |
| Body mass index (BMI) | 0.004 |
| Tobacco use | 0.419 |
| Steroid use | -0.456 |
| Bronchial asthma | 0.140 |
| Allergic rhinitis | 19.292 |
| Nasal septum deviation | 18.698 |
| Chronic obstructive pulmonary disease (COPD) | 19.281 |
An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.
| participants | Clarithromycin Modified Release |
|---|---|
| Any adverse event | 2 |
| Serious adverse event | 0 |
Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.
| percentage of participants | Clarithromycin Modified Release |
|---|---|
| Percentage of Participants With Clinical Success | 86.9 (83.28 to 90.52) |
Based on the participant and physician's assessment, overall symptom response was classified as follows: * Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment. * Slow Responders: participants showing clinical recovery between Day 6 \& Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms). * Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms).
| participants | Clarithromycin Modified Release |
|---|---|
| Fast responders | 43 |
| Slow responders | 248 |
| Failure response | 44 |
Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.
| participants | Clarithromycin Modified Release |
|---|---|
| Resolved | 120 |
| Improved | 70 |
| No change | 5 |
| No fever | 140 |
Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.
| participants | Clarithromycin Modified Release |
|---|---|
| Resolved | 93 |
| Improved | 100 |
| No change | 23 |
| Worsened | 4 |
| No cough | 113 |
Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.
| participants | Clarithromycin Modified Release |
|---|---|
| Resolved | 88 |
| Improved | 102 |
| No change | 19 |
| Worsened | 4 |
| No sputum | 120 |
Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.
| participants | Clarithromycin Modified Release |
|---|---|
| Resolved | 31 |
| Improved | 28 |
| No change | 2 |
| Worsened | 1 |
| No dyspnea | 273 |
Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.
| participants | Clarithromycin Modified Release |
|---|---|
| Resolved | 30 |
| Improved | 13 |
| No change | 4 |
| No abnormal breath sounds | 288 |
Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.
| participants | Clarithromycin Modified Release |
|---|---|
| Resolved | 55 |
| Improved | 56 |
| No change | 2 |
| No rhinorrhea | 222 |
Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.
| participants | Clarithromycin Modified Release |
|---|---|
| Resolved | 75 |
| Improved | 98 |
| No change | 6 |
| No post-nasal discharge | 154 |
Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.
| percentage of participants | Clarithromycin Modified Release |
|---|---|
| 6 days | 43 |
| 7 days | 54 |
| 8 days | 3 |
Collected over 10 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clarithromycin Modified Release | — | 0/335 (0%) | 2/335 (0.6%) |
| Event | Clarithromycin Modified Release |
|---|---|
| DyspepsiaGastrointestinal disorders | 1/335 |
| DiarrheaGastrointestinal disorders | 1/335 |
| Age Continuous(years) | Clarithromycin Modified Release |
|---|---|
| Mean | 35.48 ± 12.552 |
| Sex/Gender, Customized(participants) | Clarithromycin Modified Release |
|---|---|
| Male | 205 |
| Female | 122 |
| Missing | 8 |
| Region of Enrollment(participants) | Clarithromycin Modified Release |
|---|---|
| Egypt | 120 |
| Saudi Arabia | 215 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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