Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT01076153

First received: February 24, 2010

Last updated: July 1, 2011

Last verified: June 2011

History of Changes

Results First Received: April 22, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Respiratory Tract Infection
Intervention:	Drug: Clarithromycin (Klacid® MR)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 760 participants were enrolled in the study. 694 were analyzed as 66 participants had protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).

Reporting Groups

	Description
Klacid MR	Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.

Participant Flow: Overall Study

	Klacid MR
STARTED	760
COMPLETED	749
NOT COMPLETED	11
Symptoms improved/resolved	10
Adverse Event	1

Baseline Characteristics

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Reporting Groups

	Description
Klacid MR	The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.

Baseline Measures

	Klacid MR
Number of Participants [units: participants]	694
Age ^[1] [units: years] Mean ± Standard Deviation	41.16 ± 14.22
Age, Customized ^[1] [units: participants]
18 to 20 years	28
21 to 30 years	154
31 to 40 years	204
41 to 50 years	141
51 to 60 years	102
Over 60 years	65
Gender ^[1] [units: participants]
Female	404
Male	290
Region of Enrollment ^[1] [units: participants]
Thailand	694
Diagnosis ^[2] [units: participants]
Upper respiratory tract infection	510
Lower respiratory tract infection	165
Both upper and lower respiratory tract infections	19
Risk factor: Smoking status ^[3] [units: participants]
Participant was a smoker	164
Participant did not smoke	530

[1]	Based on per-protocol population (694 participants).
[2]	Participant diagnosis at study entry for the per-protocol population (694 participants).
[3]	Whether or not participants smoked cigarettes for the per-protocol population (694 participants).

Outcome Measures

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1. Primary:

Average Time From Baseline to Recovery From Cough and Other Symptoms [ Time Frame: Baseline to 14 days ]

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2. Secondary:

Number and Type of Adverse Events [ Time Frame: Baseline to 14 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110

No publications provided

Responsible Party:	Savary Om/ Regional Medical Director, Abbott Laboratories
ClinicalTrials.gov Identifier:	NCT01076153 History of Changes
Other Study ID Numbers:	P08-331
Study First Received:	February 24, 2010
Results First Received:	April 22, 2011
Last Updated:	July 1, 2011
Health Authority:	Thailand: Food and Drug Administration

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