Trial Outcomes & Findings for Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER) (NCT NCT01075204)

NCT ID: NCT01075204

Last Updated: 2013-02-12

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 335 participants
• Primary outcome timeframe: Day 1 to Day 5
• Results posted on: 2013-02-12

Participant Flow

Participant milestones

Measure	Clarithromycin Modified Release Participants 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.
Overall Study STARTED	335
Overall Study COMPLETED	335
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)

Baseline characteristics by cohort

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Age Continuous	35.48 years STANDARD_DEVIATION 12.552 • n=5 Participants
Sex/Gender, Customized Male	205 participants n=5 Participants
Sex/Gender, Customized Female	122 participants n=5 Participants
Sex/Gender, Customized Missing	8 participants n=5 Participants
Region of Enrollment Egypt	120 participants n=5 Participants
Region of Enrollment Saudi Arabia	215 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 5

Population: All enrolled participants. For the individual symptoms, N indicates the number of participants with that symptom at Baseline and with available recovery data.

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Percentage of Participants With a Fast Recovery Malaise response [N=68]	30.9 percentage of participants
Percentage of Participants With a Fast Recovery All symptoms together [N=335]	12.8 percentage of participants
Percentage of Participants With a Fast Recovery Fever response [N=184]	54.3 percentage of participants
Percentage of Participants With a Fast Recovery Cough response [N=215]	27.4 percentage of participants
Percentage of Participants With a Fast Recovery Sputum response [N=212]	29.7 percentage of participants
Percentage of Participants With a Fast Recovery Dyspnea response [N=62]	37.1 percentage of participants
Percentage of Participants With a Fast Recovery Abnormal breath sounds response [N=47]	42.6 percentage of participants
Percentage of Participants With a Fast Recovery Rhinorrhea response [N=113]	28.3 percentage of participants
Percentage of Participants With a Fast Recovery Nasal congestion response [N=233]	33.5 percentage of participants
Percentage of Participants With a Fast Recovery Post-nasal discharge response [N=178]	18.5 percentage of participants
Percentage of Participants With a Fast Recovery Sneezing response [N=87]	25.3 percentage of participants
Percentage of Participants With a Fast Recovery Sore throat response [N=200]	38.0 percentage of participants
Percentage of Participants With a Fast Recovery Painful swallowing response [N=162]	38.9 percentage of participants
Percentage of Participants With a Fast Recovery Itchy watery eye response [N=33]	6.1 percentage of participants
Percentage of Participants With a Fast Recovery Myalgia response [N=79]	34.2 percentage of participants

PRIMARY outcome

Timeframe: 10 days

Population: All enrolled patients.

Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Percentage of Participants With Clinical Success	86.9 percentage of participants Interval 83.28 to 90.52

PRIMARY outcome

Timeframe: 10 days

Population: All enrolled patients

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).

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Classification of Overall Response Fast responders	43 participants
Classification of Overall Response Slow responders	248 participants
Classification of Overall Response Failure response	44 participants

SECONDARY outcome

Timeframe: 10 days

Population: All enrolled patients

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Percentage of Participants With Treatment Failure Treatment failure total	13.1 percentage of participants
Percentage of Participants With Treatment Failure All symptoms improved but not resolved	0.9 percentage of participants
Percentage of Participants With Treatment Failure Some symptoms improved and some resolved	3.9 percentage of participants
Percentage of Participants With Treatment Failure Some symptoms resolved/improved, others unchanged	6.9 percentage of participants
Percentage of Participants With Treatment Failure Some symptoms resolved/improved/others worsened	1.5 percentage of participants

SECONDARY outcome

Timeframe: 10 days

Population: All enrolled patients

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Factors Affecting the Speed of Recovery Age	-0.007 coefficient
Factors Affecting the Speed of Recovery Gender	0.216 coefficient
Factors Affecting the Speed of Recovery Body mass index (BMI)	0.004 coefficient
Factors Affecting the Speed of Recovery Tobacco use	0.419 coefficient
Factors Affecting the Speed of Recovery Steroid use	-0.456 coefficient
Factors Affecting the Speed of Recovery Bronchial asthma	0.140 coefficient
Factors Affecting the Speed of Recovery Allergic rhinitis	19.292 coefficient
Factors Affecting the Speed of Recovery Nasal septum deviation	18.698 coefficient
Factors Affecting the Speed of Recovery Chronic obstructive pulmonary disease (COPD)	19.281 coefficient

SECONDARY outcome

Timeframe: 10 days

Population: All enrolled patients.

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Number of Participants With Adverse Events Any adverse event	2 participants
Number of Participants With Adverse Events Serious adverse event	0 participants

SECONDARY outcome

Timeframe: 10 days

Population: All enrolled patients

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Fever Status at End of Study Resolved	120 participants
Fever Status at End of Study Improved	70 participants
Fever Status at End of Study No change	5 participants
Fever Status at End of Study No fever	140 participants

SECONDARY outcome

Timeframe: 10 days

Population: Enrolled patients with cough data available.

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.

Outcome measures

Measure	Clarithromycin Modified Release n=333 Participants Participants 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.
Cough Status at End of Study Resolved	93 participants
Cough Status at End of Study Improved	100 participants
Cough Status at End of Study No change	23 participants
Cough Status at End of Study Worsened	4 participants
Cough Status at End of Study No cough	113 participants

SECONDARY outcome

Timeframe: 10 days

Population: Enrolled patients with sputum data available.

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.

Outcome measures

Measure	Clarithromycin Modified Release n=333 Participants Participants 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.
Sputum Status at End of Study Resolved	88 participants
Sputum Status at End of Study Improved	102 participants
Sputum Status at End of Study No change	19 participants
Sputum Status at End of Study Worsened	4 participants
Sputum Status at End of Study No sputum	120 participants

SECONDARY outcome

Timeframe: 10 days

Population: All enrolled patients

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Dyspnea Status at End of Study Worsened	1 participants
Dyspnea Status at End of Study Resolved	31 participants
Dyspnea Status at End of Study Improved	28 participants
Dyspnea Status at End of Study No change	2 participants
Dyspnea Status at End of Study No dyspnea	273 participants

SECONDARY outcome

Timeframe: 10 days

Population: All enrolled patients

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Abnormal Breathing Sounds Status at End of Study Resolved	30 participants
Abnormal Breathing Sounds Status at End of Study Improved	13 participants
Abnormal Breathing Sounds Status at End of Study No change	4 participants
Abnormal Breathing Sounds Status at End of Study No abnormal breath sounds	288 participants

SECONDARY outcome

Timeframe: 10 days

Population: All enrolled patients

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Rhinorrhea Status at End of Study Resolved	55 participants
Rhinorrhea Status at End of Study Improved	56 participants
Rhinorrhea Status at End of Study No change	2 participants
Rhinorrhea Status at End of Study No rhinorrhea	222 participants

SECONDARY outcome

Timeframe: 10 days

Population: Enrolled patients with post-nasal discharge data available.

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.

Outcome measures

Measure	Clarithromycin Modified Release n=333 Participants Participants 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.
Post-nasal Discharge Status at End of Study Resolved	75 participants
Post-nasal Discharge Status at End of Study Improved	98 participants
Post-nasal Discharge Status at End of Study No change	6 participants
Post-nasal Discharge Status at End of Study No post-nasal discharge	154 participants

SECONDARY outcome

Timeframe: 10 days

Population: All enrolled patients.

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.

Outcome measures

Measure	Clarithromycin Modified Release n=335 Participants Participants 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.
Percentage of Participants Compliant With Treatment 6 days	43 percentage of participants
Percentage of Participants Compliant With Treatment 7 days	54 percentage of participants
Percentage of Participants Compliant With Treatment 8 days	3 percentage of participants

Adverse Events

Clarithromycin Modified Release

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Clarithromycin Modified Release n=335 participants at risk Participants 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.
Gastrointestinal disorders Dyspepsia	0.30% 1/335 • 10 days
Gastrointestinal disorders Diarrhea	0.30% 1/335 • 10 days

Additional Information

Esther Oppermann, Clinical Trial Manager

Abbott

Phone: 49 511 6750 3954

Email: esther.oppermann@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER