Trial · NCT01075204
Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
NCT01075204, Completed, Abbott; results first posted 2013-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER). Trials, record NCT01075204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01075204
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
- NCT number
- NCT01075204
- Status
- Completed
- Enrollment
- 335 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Respiratory Tract Infection
- Interventions
- clarithromycin modified release 500 mg
- First posted
- 2010-02-25
- Last updated
- 2013-02-12
- Results first posted
- 2013-01-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Fast Recovery | Day 1 to Day 5 | 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. |
| Primary | Percentage of Participants With Clinical Success | 10 days | Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment. |
| Primary | Classification of Overall Response | 10 days | 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). |
| Secondary | Percentage of Participants With Treatment Failure | 10 days | 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. |
| Secondary | Factors Affecting the Speed of Recovery | 10 days | 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. |
| Secondary | Number of Participants With Adverse Events | 10 days | 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. |
| Secondary | Fever Status at End of Study | 10 days | 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. |
| Secondary | Cough Status at End of Study | 10 days | 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. |
| Secondary | Sputum Status at End of Study | 10 days | 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. |
| Secondary | Dyspnea Status at End of Study | 10 days | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Fast Recovery | Day 1 to Day 5 | All enrolled participants. For the individual symptoms, N indicates the number of participants with that symptom at Baseline and with available recovery data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Failure | 10 days | All enrolled patients | percentage of participants | NUMBER |
| SECONDARY | Factors Affecting the Speed of Recovery | 10 days | All enrolled patients | coefficient | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | 10 days | All enrolled patients. | participants | NUMBER |
| PRIMARY | Percentage of Participants With Clinical Success | 10 days | All enrolled patients. | percentage of participants | NUMBER |
| PRIMARY | Classification of Overall Response | 10 days | All enrolled patients | participants | NUMBER |
| SECONDARY | Fever Status at End of Study | 10 days | All enrolled patients | participants | NUMBER |
| SECONDARY | Cough Status at End of Study | 10 days | Enrolled patients with cough data available. | participants | NUMBER |
| SECONDARY | Sputum Status at End of Study | 10 days | Enrolled patients with sputum data available. | participants | NUMBER |
| SECONDARY | Dyspnea Status at End of Study | 10 days | All enrolled patients | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | All symptoms together [N=335] | 12.8 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Fever response [N=184] | 54.3 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Cough response [N=215] | 27.4 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Sputum response [N=212] | 29.7 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Dyspnea response [N=62] | 37.1 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Abnormal breath sounds response [N=47] | 42.6 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Rhinorrhea response [N=113] | 28.3 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Nasal congestion response [N=233] | 33.5 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Post-nasal discharge response [N=178] | 18.5 | percentage of participants | |
| Percentage of Participants With a Fast Recovery | Clarithromycin Modified Release | Sneezing response [N=87] | 25.3 | percentage of participants |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clarithromycin Modified Release | 335 | |
| Overall Study | COMPLETED | Clarithromycin Modified Release | 335 | |
| Overall Study | NOT COMPLETED | Clarithromycin Modified Release | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dyspepsia | Gastrointestinal disorders | Clarithromycin Modified Release | 1 | 335 | |
| other | Diarrhea | Gastrointestinal disorders | Clarithromycin Modified Release | 1 | 335 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clarithromycin Modified Release | ||
| Total, other adverse events | Clarithromycin Modified Release | 2 | 335 |
| Total, serious adverse events | Clarithromycin Modified Release | 0 | 335 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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