Respiratory Tract InfectionCLOSERNCT01075204

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

An observational study of Respiratory Tract Infection, run by Abbott at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Tract Infection
What is being tested?: clarithromycin modified release 500 mg
How many people: 335 participants
Where: 12 sitesin 2 countries
Study dates: Jan 2011to Jan 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Adults, equal to or more than 18 years years of age
Patients with respiratory tract infections, including any of the following:
Acute tracheitis, acute tracheobronchitis
Acute sinusitis
Chronic sinusitis
Acute tonsillopharyngitis

Show all 9Show fewer

Acute bronchitis
Mild community-acquired pneumonia
Acute exacerbation of chronic bronchitis

Who cannot join

Known hypersensitivity to or previously intolerant of macrolides.
Illness severe enough to warrant hospitalization or parenteral therapy.
Concomitant use of any of the following medications:
Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir.

Show all 9Show fewer

Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm).
Mental condition rendering the subject unable to understand the nature of the study.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

Egypt11 sites

Site Ref # / Investigator 50162
Cairo
Site Ref # / Investigator 50215
Cairo
Site Ref # / Investigator 50225
Cairo
Site Ref # / Investigator 50235
Cairo
Site Ref # / Investigator 50236
Cairo
Site Ref # / Investigator 50237
Cairo
Site Ref # / Investigator 51204
Cairo
Site Ref # / Investigator 51205
Cairo
Site Ref # / Investigator 50213
Helwan
Site Ref # / Investigator 51206
Tanta
Site Ref # / Investigator 51207
Tanta

Other trials in Egypt

Saudi Arabia1 site

Site Ref # / Investigator 22543
Jeddah, 21461

Other trials in Saudi Arabia

About this study

Conditions: Respiratory Tract Infection
Being tested: clarithromycin modified release 500 mg
Keywords: Respiratory Tract Infection, Clarithromycin, Recovery
Medical subject headings: Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

clarithromycin modified release 500 mgDrug
Also called Clarithromycin Modified Release 500 mg (Klacid XL)
clarithromycin modified release 500 mg for 7 days

Study groups in NCT01075204
Study group	Role	What they receive
Clarithromycin modified release		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. Receives: Drug: clarithromycin modified release 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 10 days

Secondary outcomes (11)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Jan 2012

First posted25 Feb 2010 (estimated)
Study startJan 2011
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory Tract InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01075204
Sponsor's protocol ID: P11-989
Acronym: CLOSER
Status last verified: Feb 2013
First submitted: 23 Feb 2010
Last updated: 12 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
ClinicalTrials.gov ID: NCT01075204
Acronym / sponsor ID: CLOSER / P11-989
Conditions: Respiratory Tract Infection
Keywords: Respiratory Tract Infection, Clarithromycin, Recovery
Study type: Observational
Recruitment status: Completed
Enrolment: 335 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Eilaf
Study start: Jan 2011
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 25 Feb 2010 (estimated)
Results: Posted 30 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Clarithromycin modified release	–	Drug: clarithromycin modified release 500 mgPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (9 listed)

Adults, equal to or more than 18 years years of age
Patients with respiratory tract infections, including any of the following:

Key exclusion criteria (9 listed)

Known hypersensitivity to or previously intolerant of macrolides.
Illness severe enough to warrant hospitalization or parenteral therapy.
Concomitant use of any of the following medications:
Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
clarithromycin modified release 500 mgAlso: Clarithromycin Modified Release 500 mg (Klacid XL)clarithromycin modified release 500 mg for 7 days	Drug	Clarithromycin modified release

Primary outcome

Percentage of Participants With a Fast Recovery
Time frame: 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.
Percentage of Participants With Clinical Success
Time frame: 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.
Classification of Overall Response
Time frame: 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).

11 secondary outcomes

Percentage of Participants With Treatment Failure
Time frame: 10 days
Factors Affecting the Speed of Recovery
Time frame: 10 days
Number of Participants With Adverse Events
Time frame: 10 days
Fever Status at End of Study
Time frame: 10 days
Cough Status at End of Study
Time frame: 10 days
Sputum Status at End of Study
Time frame: 10 days
Dyspnea Status at End of Study
Time frame: 10 days
Abnormal Breathing Sounds Status at End of Study
Time frame: 10 days
Rhinorrhea Status at End of Study
Time frame: 10 days
Post-nasal Discharge Status at End of Study
Time frame: 10 days
Percentage of Participants Compliant With Treatment
Time frame: 10 days

Results and safety

Results posted to the registry on 30 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clarithromycin Modified Release	335	335

Primary outcome: Percentage of Participants With a Fast Recovery

Time frame: Day 1 to Day 5. Number. Unit: percentage of participants

Measure	Clarithromycin Modified Release n = 335
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

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

Primary outcome: Percentage of Participants With Clinical Success

Time frame: 10 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Clarithromycin Modified Release n = 335
Value	86.9 (83.28 to 90.52)

Population analysed: All enrolled patients.

Primary outcome: Classification of Overall Response

Time frame: 10 days. Number. Unit: participants

Measure	Clarithromycin Modified Release n = 335
Fast responders	43
Slow responders	248
Failure response	44

Population analysed: All enrolled patients

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clarithromycin Modified Release	0 of 335 (0%)	2 of 335 (0.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamed Tahoun, Bachelor study director

Abbott Laboratories - Saudi Arabia

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Tract Infection, run by Abbott at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Fast Recovery (time frame: Day 1 to Day 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01075204.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.