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

Sponsor:	Abbott
Collaborator:	Eilaf CRO
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT01075204

Purpose

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

Condition	Intervention
Respiratory Tract Infection	Drug: clarithromycin (Klacid XL)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)

Resource links provided by NLM:

Drug Information available for: Clarithromycin

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Time to recovery (defined as the number of days required to return to baseline after initiation of Klacid). Baseline is defined as the symptom status prior to the onset of RTI. Fast recovery is less than or equal to 5 days from start of Klacid therapy. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events: record the number, symptoms and severity of adverse events for Klacid XL. The action taken, outcome and relationship to Klacid XL treatment should be addressed. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Percentage of treatment failure:defined as failure to return to baseline before 10 days or the requirement of new treatments or medications during the first 10 days for persistence or aggravation of symptoms. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Factors affecting the speed of recovery:identifying variables independently and significantly associated with the speed of recovery. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	418
Study Start Date:	January 2011
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
RTI patients on clarithromycin (Klacid XL) Patients with respiratory tract infection (upper or lower), between ages of 18 to 70 years.	Drug: clarithromycin (Klacid XL) clarithromycin modified release (Klacid XL) for 7 days. Other Names: clarithromycin Modified Release Klacid XL Biaxin XL

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Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic

Criteria

Inclusion Criteria:

- Patients with Respiratory Tract Infections, adults, between 18 & 70 years

Exclusion Criteria:

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.
Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment.(creatinine clearance under 30 ml/min, AST, ALT and GMT equal or more than 3x higher level in comparison with the norm)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075204

Contacts

Contact: Tarek Mohamed Azzam	+966-2-6655000
Contact: Tamer Amin	+966-2-6655000

Locations

Egypt
Site Ref # / Investigator 50162	Completed
Cairo, Egypt
Site Ref # / Investigator 50237	Completed
Cairo, Egypt
Site Ref # / Investigator 50215	Completed
Cairo, Egypt
Site Ref # / Investigator 50236	Completed
Cairo, Egypt
Site Ref # / Investigator 50235	Completed
Cairo, Egypt
Site Ref # / Investigator 50225	Completed
Cairo, Egypt
Site Ref # / Investigator 51204	Completed
Cairo, Egypt
Site Ref # / Investigator 51205	Completed
Cairo, Egypt
Site Ref # / Investigator 50213	Completed
Helwan, Egypt
Site Ref # / Investigator 51206	Completed
Tanta, Egypt
Site Ref # / Investigator 51207	Completed
Tanta, Egypt
Saudi Arabia
Site Ref # / Investigator 22543	Recruiting
Jeddah, Saudi Arabia, 21461
Principal Investigator: Site Ref # / Investigator 22543

Sponsors and Collaborators

Abbott

Eilaf CRO

Investigators

Study Director:

Ashraf Kamel, MD

Abbott Laboratories - Saudi Arabia

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01075204 History of Changes
Other Study ID Numbers:	P11-989
Study First Received:	February 23, 2010
Last Updated:	January 16, 2012
Health Authority:	Saudi Arabia: Ethics Committee; Egypt: Ministry of Health and Population

Keywords provided by Abbott:

Respiratory Tract Infection
Clarithromycin
Recovery

Additional relevant MeSH terms:

Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012