Trial Outcomes & Findings for Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR (NCT NCT01076153)

Last Updated: 2011-07-12

Results Overview

Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.

Recruitment status

COMPLETED

Target enrollment

760 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2011-07-12

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	760
Overall Study COMPLETED	749
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Symptoms improved/resolved	10
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Klacid MR n=694 Participants The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.
Age Continuous	41.16 years STANDARD_DEVIATION 14.22 • n=99 Participants
Age, Customized 18 to 20 years	28 participants n=99 Participants
Age, Customized 21 to 30 years	154 participants n=99 Participants
Age, Customized 31 to 40 years	204 participants n=99 Participants
Age, Customized 41 to 50 years	141 participants n=99 Participants
Age, Customized 51 to 60 years	102 participants n=99 Participants
Age, Customized Over 60 years	65 participants n=99 Participants
Sex: Female, Male Female	404 Participants n=99 Participants
Sex: Female, Male Male	290 Participants n=99 Participants
Region of Enrollment Thailand	694 participants n=99 Participants
Diagnosis Upper respiratory tract infection	510 participants n=99 Participants
Diagnosis Lower respiratory tract infection	165 participants n=99 Participants
Diagnosis Both upper and lower respiratory tract infections	19 participants n=99 Participants
Risk factor: Smoking status Participant was a smoker	164 participants n=99 Participants
Risk factor: Smoking status Participant did not smoke	530 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline to 14 days

Population: The per-protocol population consisted of 694 participants as 66 participants were excluded for 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).

Outcome measures

Outcome measures
Measure	Klacid MR (Total Number Recovered) n=658 Participants Male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR who were in the recovered population.	Klacid MR (URTI, Recovered) n=491 Participants Participants in the recovered population who had a diagnosis of upper respiratory tract infection (URTI) at study entry.	Klacid MR (LRTI, Recovered) n=148 Participants Participants in the recovered population who had a diagnosis of lower respiratory tract infection (LRTI) at study entry.	Klacid MR (URTI and LRTI, Recovered) n=19 Participants Participants in the recovered population who had a diagnosis of both upper and lower respiratory tract infections at study entry.
Average Time From Baseline to Recovery From Cough and Other Symptoms	7.06 Days Standard Deviation 2.65	6.76 Days Standard Deviation 2.11	7.82 Days Standard Deviation 3.75	9.05 Days Standard Deviation 3.08

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: The safety population included all participants who took at least 1 dose of Klacid.

Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.

Outcome measures

Outcome measures
Measure	Klacid MR (Total Number Recovered) n=760 Participants Male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR who were in the recovered population.	Klacid MR (URTI, Recovered) Participants in the recovered population who had a diagnosis of upper respiratory tract infection (URTI) at study entry.	Klacid MR (LRTI, Recovered) Participants in the recovered population who had a diagnosis of lower respiratory tract infection (LRTI) at study entry.	Klacid MR (URTI and LRTI, Recovered) Participants in the recovered population who had a diagnosis of both upper and lower respiratory tract infections at study entry.
Number and Type of Adverse Events Non-serious Adverse Events	7 Events	—	—	—
Number and Type of Adverse Events Serious Adverse Events	0 Events	—	—	—

Adverse Events

Klacid MR

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Klacid MR n=760 participants at risk 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.
Gastrointestinal disorders Dysgeusia	0.39% 3/760 • Number of events 4 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid MR.
Gastrointestinal disorders Abdominal pain	0.13% 1/760 • Number of events 1 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid MR.
Cardiac disorders Palpitations	0.13% 1/760 • Number of events 1 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid MR.
Musculoskeletal and connective tissue disorders Muscle strain	0.13% 1/760 • Number of events 1 • All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid MR.

Additional Information

Global Medical Services

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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.
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